NCT02391948 is a clinical trial in Cerebral Palsy, sponsored by University of Washington.

Who is sponsoring NCT02391948?

NCT02391948 is sponsored by University of Washington.

What condition does NCT02391948 study?

NCT02391948 studies Cerebral Palsy.

Is NCT02391948 still recruiting?

NCT02391948 is currently completed. Last updated 19 April 2019.

Are results published for NCT02391948?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-04-19 · How we verify

NCT02391948

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay

Completed Results posted Last updated 19 April 2019

What this trial tests

trial in Cerebral Palsy in 724 participants. Completed in 31 March 2017.

Timeline

1 July 2013

Primary endpoint
31 August 2016

31 March 2017

Quick facts

Lead sponsor	University of Washington
Status	Completed
Study type	OBSERVATIONAL
Enrollment	724
Start date	1 July 2013
Primary completion	31 August 2016
Estimated completion	31 March 2017
Sites	5 locations across Canada, United States

Conditions studied

Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

University of Washington

Who can join

Adults 18 Months to 12, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Early Clinical Assessment of Balance (ECAB) Primary · up to 24-months

The ECAB addresses postural control and balance across the developmental sequence. Part I has 7 items (with numbers 1,4,5,6,7 scored bilaterally): 1) lateral head righting, 2) head righting in extension, 3) head righting in flexion, 4) rotation in the trunk, 5) equilibrium reactions in sitting, 6) protective extension to the side, and 7) protective extension backwards. The items are scored on a scale of 0 = no response to 3 = complete \& consistent response. Part II has 6 items: 1) sitting with back unsupported but feet supported, 2) moving from sitting to standing, 3) standing unsupported wit

Baseline: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	79.4	± 19.6
Gross Motor Function Classification System (GMFCS) Level II	61.1	± 19.2
Gross Motor Function Classification System (GMFCS) Level III	38.0	± 14.8
Gross Motor Function Classification System (GMFCS) Level IV	23.0	± 8.8
Gross Motor Function Classification System (GMFCS) Level V	7.3	± 5.1

Baseline: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	97.4	± 5.1
Gross Motor Function Classification System (GMFCS) Level II	86.0	± 15.8
Gross Motor Function Classification System (GMFCS) Level III	44.3	± 14.3
Gross Motor Function Classification System (GMFCS) Level IV	24.7	± 10.0
Gross Motor Function Classification System (GMFCS) Level V	6.4	± 6.8

6-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	80.4	± 18.9
Gross Motor Function Classification System (GMFCS) Level II	61.6	± 19.8
Gross Motor Function Classification System (GMFCS) Level III	37.6	± 12.7
Gross Motor Function Classification System (GMFCS) Level IV	26.1	± 8.4
Gross Motor Function Classification System (GMFCS) Level V	8.1	± 7.5

6-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	97.4	± 5.2
Gross Motor Function Classification System (GMFCS) Level II	86.1	± 16.9
Gross Motor Function Classification System (GMFCS) Level III	49.0	± 17.0
Gross Motor Function Classification System (GMFCS) Level IV	24.8	± 11.9
Gross Motor Function Classification System (GMFCS) Level V	7.2	± 6.6

12-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	86.3	± 14.3
Gross Motor Function Classification System (GMFCS) Level II	64.9	± 20.8
Gross Motor Function Classification System (GMFCS) Level III	37.5	± 7.9
Gross Motor Function Classification System (GMFCS) Level IV	26.3	± 7.9
Gross Motor Function Classification System (GMFCS) Level V	7.6	± 6.3

12-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	98.1	± 4.4
Gross Motor Function Classification System (GMFCS) Level II	86.9	± 15.8
Gross Motor Function Classification System (GMFCS) Level III	50.6	± 19.0
Gross Motor Function Classification System (GMFCS) Level IV	25.0	± 10.9
Gross Motor Function Classification System (GMFCS) Level V	8.0	± 7.9

18-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	86.6	± 15.1
Gross Motor Function Classification System (GMFCS) Level II	62.8	± 18.9
Gross Motor Function Classification System (GMFCS) Level III	41.4	± 12.3
Gross Motor Function Classification System (GMFCS) Level IV	29.3	± 8.2
Gross Motor Function Classification System (GMFCS) Level V	7.7	± 7.1

18-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	97.9	± 4.8
Gross Motor Function Classification System (GMFCS) Level II	86.9	± 16.5
Gross Motor Function Classification System (GMFCS) Level III	52.6	± 19.9
Gross Motor Function Classification System (GMFCS) Level IV	25.9	± 11.7
Gross Motor Function Classification System (GMFCS) Level V	7.4	± 6.9

Spinal Alignment and Range of Motion Measure (SAROMM) Primary · up to 24-months

The SAROMM addresses joint range of motion, extensibility, and spinal alignment. The Spinal Alignment Subscale contains 4 items and the Range of Motion and Extensibility Subscale has 22 items. Each item is scored on a 5-point Likert scale, with 0 = normal alignment and range with active correction, 1 = normal alignment and range with passive correction, and 2, 3, and 4 indicating fixed deformities or contractures that are "mild", "moderate", or "severe" based on pre-specified cut points, and supported by photographs in the training manual. Scores are reported by calculating the average of scor

Baseline: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.3	± 0.3
Gross Motor Function Classification System (GMFCS) Level II	0.6	± 0.4
Gross Motor Function Classification System (GMFCS) Level III	0.9	± 0.4
Gross Motor Function Classification System (GMFCS) Level IV	1.1	± 0.5
Gross Motor Function Classification System (GMFCS) Level V	1.4	± 0.5

Baseline: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.4	± 0.3
Gross Motor Function Classification System (GMFCS) Level II	0.6	± 0.4
Gross Motor Function Classification System (GMFCS) Level III	1.0	± 0.5
Gross Motor Function Classification System (GMFCS) Level IV	1.5	± 0.6
Gross Motor Function Classification System (GMFCS) Level V	1.9	± 0.6

6-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.3	± 0.3
Gross Motor Function Classification System (GMFCS) Level II	0.6	± 0.4
Gross Motor Function Classification System (GMFCS) Level III	0.8	± 0.3
Gross Motor Function Classification System (GMFCS) Level IV	1.0	± 0.6
Gross Motor Function Classification System (GMFCS) Level V	1.2	± 0.6

6-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.4	± 0.3
Gross Motor Function Classification System (GMFCS) Level II	0.6	± 0.4
Gross Motor Function Classification System (GMFCS) Level III	0.8	± 0.4
Gross Motor Function Classification System (GMFCS) Level IV	1.3	± 0.6
Gross Motor Function Classification System (GMFCS) Level V	1.9	± 0.6

12-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.3	± 0.2
Gross Motor Function Classification System (GMFCS) Level II	0.6	± 0.4
Gross Motor Function Classification System (GMFCS) Level III	0.8	± 0.4
Gross Motor Function Classification System (GMFCS) Level IV	1.1	± 0.5
Gross Motor Function Classification System (GMFCS) Level V	1.4	± 0.6

12-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.4	± 0.3
Gross Motor Function Classification System (GMFCS) Level II	0.6	± 0.4
Gross Motor Function Classification System (GMFCS) Level III	0.9	± 0.4
Gross Motor Function Classification System (GMFCS) Level IV	1.3	± 0.5
Gross Motor Function Classification System (GMFCS) Level V	2.0	± 0.6

18-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.3	± 0.3
Gross Motor Function Classification System (GMFCS) Level II	0.6	± 0.4
Gross Motor Function Classification System (GMFCS) Level III	0.8	± 0.4
Gross Motor Function Classification System (GMFCS) Level IV	1.0	± 0.5
Gross Motor Function Classification System (GMFCS) Level V	1.3	± 0.6

18-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.4	± 0.3
Gross Motor Function Classification System (GMFCS) Level II	0.7	± 0.4
Gross Motor Function Classification System (GMFCS) Level III	0.9	± 0.3
Gross Motor Function Classification System (GMFCS) Level IV	1.3	± 0.6
Gross Motor Function Classification System (GMFCS) Level V	1.9	± 0.6

Functional Strength Assessment (FSA) Primary · up to 24-months

The FSA addresses force production ability in the neck and trunk flexor and extensor and bilateral hip and knee extensor and shoulder flexor muscle groups. Each muscle group is rated on a five-point ordinal scale from 1 = only flicker of contraction or just initiates movement against gravity to 5 = full available range against gravity and strong resistance. Scores are reported by calculating the average of scores across all 8 items. Scores range from 1 to 5. A higher score represents better force production ability.

Baseline: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.0	± 0.7
Gross Motor Function Classification System (GMFCS) Level II	3.6	± 0.6
Gross Motor Function Classification System (GMFCS) Level III	3.1	± 0.6
Gross Motor Function Classification System (GMFCS) Level IV	2.6	± 0.7
Gross Motor Function Classification System (GMFCS) Level V	1.8	± 0.7

Baseline: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.5	± 0.5
Gross Motor Function Classification System (GMFCS) Level II	4.1	± 0.6
Gross Motor Function Classification System (GMFCS) Level III	3.6	± 0.8
Gross Motor Function Classification System (GMFCS) Level IV	2.7	± 0.8
Gross Motor Function Classification System (GMFCS) Level V	1.5	± 0.5

6-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.0	± 0.7
Gross Motor Function Classification System (GMFCS) Level II	3.6	± 0.6
Gross Motor Function Classification System (GMFCS) Level III	3.1	± 0.6
Gross Motor Function Classification System (GMFCS) Level IV	2.7	± 0.6
Gross Motor Function Classification System (GMFCS) Level V	1.7	± 0.6

6-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.5	± 0.5
Gross Motor Function Classification System (GMFCS) Level II	4.1	± 0.6
Gross Motor Function Classification System (GMFCS) Level III	3.6	± 0.8
Gross Motor Function Classification System (GMFCS) Level IV	2.7	± 0.8
Gross Motor Function Classification System (GMFCS) Level V	1.6	± 0.6

12-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.2	± 0.6
Gross Motor Function Classification System (GMFCS) Level II	3.7	± 0.6
Gross Motor Function Classification System (GMFCS) Level III	3.2	± 0.7
Gross Motor Function Classification System (GMFCS) Level IV	2.8	± 0.5
Gross Motor Function Classification System (GMFCS) Level V	1.8	± 0.7

12-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.6	± 0.4
Gross Motor Function Classification System (GMFCS) Level II	4.2	± 0.6
Gross Motor Function Classification System (GMFCS) Level III	3.6	± 0.8
Gross Motor Function Classification System (GMFCS) Level IV	2.7	± 0.8
Gross Motor Function Classification System (GMFCS) Level V	1.6	± 0.5

18-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.0	± 0.7
Gross Motor Function Classification System (GMFCS) Level II	3.5	± 0.7
Gross Motor Function Classification System (GMFCS) Level III	3.1	± 0.7
Gross Motor Function Classification System (GMFCS) Level IV	2.9	± 0.6
Gross Motor Function Classification System (GMFCS) Level V	1.7	± 0.6

18-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.5	± 0.5
Gross Motor Function Classification System (GMFCS) Level II	4.1	± 0.7
Gross Motor Function Classification System (GMFCS) Level III	3.7	± 0.7
Gross Motor Function Classification System (GMFCS) Level IV	2.8	± 0.8
Gross Motor Function Classification System (GMFCS) Level V	1.7	± 0.5

Six and One-minute Walk Test (6MWT, 1MWT) Primary · up to 24-months

The 6MWT and 1MWT are submaximal, clinical exercise tests, in which the total distance traveled in 1-minute and 6-minutes, under controlled conditions, are measured. Within this study, the 6MWT/1MWT was conducted indoors or outdoors on a large, flat, hard terrain for children who were 3 years or older and who were walking without another person's assistance (GMFCS I, II, III). A surveyor's measure wheel was used to calculate the total distance (# of feet) walked and a stopwatch to keep track of the allocated time. Standardized directions are used to encourage the child to walk as far as possib

6MWT, Baseline: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	1080.3	± 273.6
Gross Motor Function Classification System (GMFCS) Level II	697.3	± 347.1
Gross Motor Function Classification System (GMFCS) Level III	396.2	± 317.6

6MWT, Baseline: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	1386.2	± 342.5
Gross Motor Function Classification System (GMFCS) Level II	1041.8	± 303.4
Gross Motor Function Classification System (GMFCS) Level III	616.9	± 307.0

6MWT, 6-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	1012.8	± 301.6
Gross Motor Function Classification System (GMFCS) Level II	611.1	± 314.5
Gross Motor Function Classification System (GMFCS) Level III	359.5	± 273.8

6MWT, 6-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	1370.0	± 321.1
Gross Motor Function Classification System (GMFCS) Level II	1075.0	± 322.1
Gross Motor Function Classification System (GMFCS) Level III	574.0	± 312.9

6MWT, 12-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	1026.7	± 282.7
Gross Motor Function Classification System (GMFCS) Level II	658.9	± 339.4
Gross Motor Function Classification System (GMFCS) Level III	314.6	± 237.1

6MWT, 12-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	1378.4	± 325.3
Gross Motor Function Classification System (GMFCS) Level II	1047.7	± 356.5
Gross Motor Function Classification System (GMFCS) Level III	690.7	± 261.1

6MWT, 18-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	1020.1	± 311.5
Gross Motor Function Classification System (GMFCS) Level II	601.6	± 239.0
Gross Motor Function Classification System (GMFCS) Level III	331.6	± 218.2

6MWT, 18-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	1351.1	± 324.4
Gross Motor Function Classification System (GMFCS) Level II	1109.0	± 324.2
Gross Motor Function Classification System (GMFCS) Level III	636.5	± 312.9

Early Activity Scale for Endurance (EASE) Primary · up to 24-months

The EASE includes 4 activity-based items requiring parents to rate their children's levels of energy, the frequency and need for rest, and the average amount of time their children can engage in physical activity. Scoring for each item is on a Likert scale of 1-5 with the value of 1 = "Never" to 5 = "Always". The four questions include: 1) "my child's physical activity level is similar to other children his or her age," 2) "my child has a high physical energy level and rarely needs to take rests when moving himself or herself around during daily activities and play time," 3) "my child does eno

Baseline: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.0	± 0.7
Gross Motor Function Classification System (GMFCS) Level II	3.6	± 0.8
Gross Motor Function Classification System (GMFCS) Level III	3.3	± 0.7
Gross Motor Function Classification System (GMFCS) Level IV	2.7	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	1.9	± 1.0

Baseline: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	3.7	± 0.7
Gross Motor Function Classification System (GMFCS) Level II	3.2	± 0.8
Gross Motor Function Classification System (GMFCS) Level III	3.0	± 0.8
Gross Motor Function Classification System (GMFCS) Level IV	2.8	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	1.7	± 0.7

6-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.0	± 0.7
Gross Motor Function Classification System (GMFCS) Level II	3.6	± 0.8
Gross Motor Function Classification System (GMFCS) Level III	3.3	± 0.8
Gross Motor Function Classification System (GMFCS) Level IV	2.8	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	1.9	± 0.9

6-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	3.8	± 0.8
Gross Motor Function Classification System (GMFCS) Level II	3.2	± 0.9
Gross Motor Function Classification System (GMFCS) Level III	3.1	± 0.8
Gross Motor Function Classification System (GMFCS) Level IV	2.8	± 1.0
Gross Motor Function Classification System (GMFCS) Level V	1.7	± 0.7

12-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.1	± 0.6
Gross Motor Function Classification System (GMFCS) Level II	3.7	± 0.7
Gross Motor Function Classification System (GMFCS) Level III	3.5	± 0.9
Gross Motor Function Classification System (GMFCS) Level IV	2.7	± 1.0
Gross Motor Function Classification System (GMFCS) Level V	2.1	± 0.9

12-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	3.8	± 0.8
Gross Motor Function Classification System (GMFCS) Level II	3.4	± 0.9
Gross Motor Function Classification System (GMFCS) Level III	3.2	± 0.8
Gross Motor Function Classification System (GMFCS) Level IV	2.8	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	1.7	± 0.7

18-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	4.3	± 0.7
Gross Motor Function Classification System (GMFCS) Level II	3.7	± 0.8
Gross Motor Function Classification System (GMFCS) Level III	3.4	± 0.8
Gross Motor Function Classification System (GMFCS) Level IV	2.6	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	1.7	± 0.7

18-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	3.8	± 0.9
Gross Motor Function Classification System (GMFCS) Level II	3.3	± 1.0
Gross Motor Function Classification System (GMFCS) Level III	3.1	± 0.9
Gross Motor Function Classification System (GMFCS) Level IV	2.8	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	1.7	± 0.8

Child Health Conditions Questionnaire Primary · up to 24-months

The Child Health Conditions questionnaire is a caregiver-completed measure of the extent to which health problems influence children's activities. Parents respond "yes" or "no" as to whether the child has each of the 16 health problems listed. If the child does not have a problem, a score of 0 is imputed for the next part of the question. If the child has a problem, parents are asked to judge the extent to which the problem affects the child's daily activities. This is measured using an 8-point ordinal scale from 0="does not have the problem", 1= "not at all" to 7 = "to a very great extent". S

Baseline: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.5	± 0.6
Gross Motor Function Classification System (GMFCS) Level II	0.9	± 0.7
Gross Motor Function Classification System (GMFCS) Level III	0.9	± 0.7
Gross Motor Function Classification System (GMFCS) Level IV	1.4	± 0.8
Gross Motor Function Classification System (GMFCS) Level V	2.1	± 1.0

Baseline: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.7	± 0.6
Gross Motor Function Classification System (GMFCS) Level II	1.1	± 0.9
Gross Motor Function Classification System (GMFCS) Level III	0.9	± 0.6
Gross Motor Function Classification System (GMFCS) Level IV	1.5	± 1.0
Gross Motor Function Classification System (GMFCS) Level V	2.4	± 1.1

6-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.5	± 0.6
Gross Motor Function Classification System (GMFCS) Level II	0.8	± 0.6
Gross Motor Function Classification System (GMFCS) Level III	0.9	± 0.7
Gross Motor Function Classification System (GMFCS) Level IV	1.3	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	2.2	± 0.8

6-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.7	± 0.7
Gross Motor Function Classification System (GMFCS) Level II	1.2	± 0.9
Gross Motor Function Classification System (GMFCS) Level III	0.9	± 0.6
Gross Motor Function Classification System (GMFCS) Level IV	1.4	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	2.4	± 1.1

12-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.4	± 0.5
Gross Motor Function Classification System (GMFCS) Level II	0.7	± 0.6
Gross Motor Function Classification System (GMFCS) Level III	0.8	± 0.7
Gross Motor Function Classification System (GMFCS) Level IV	1.3	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	2.2	± 0.9

12-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.7	± 0.7
Gross Motor Function Classification System (GMFCS) Level II	1.0	± 0.9
Gross Motor Function Classification System (GMFCS) Level III	0.8	± 0.6
Gross Motor Function Classification System (GMFCS) Level IV	1.5	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	2.3	± 1.1

18-month assessment: under 6 years

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.5	± 0.6
Gross Motor Function Classification System (GMFCS) Level II	0.9	± 0.8
Gross Motor Function Classification System (GMFCS) Level III	1.0	± 0.8
Gross Motor Function Classification System (GMFCS) Level IV	1.3	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	2.2	± 0.8

18-month assessment: 6 years and older

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0.7	± 0.6
Gross Motor Function Classification System (GMFCS) Level II	1.0	± 0.8
Gross Motor Function Classification System (GMFCS) Level III	0.9	± 0.7
Gross Motor Function Classification System (GMFCS) Level IV	1.3	± 0.8
Gross Motor Function Classification System (GMFCS) Level V	2.3	± 1.0

Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation Primary · up to 24-months

CEDL is a 40-item caregiver-completed questionnaire to estimate children's participation. Part 1 captures participation of the child in family/community and leisure/recreational activities. Part 1 is scored on two 5-point Likert scales: 1) how often a child participates (1=almost never to 4=very often), and 2) the degree of enjoyment (1=not at all to 5 a great deal). A Rasch analysis has converted scores into 0-100 scaled scores. A higher score represents a higher degree of 'leisure.'

Participation, Baseline: <6yrs

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	67.0	± 13.4
Gross Motor Function Classification System (GMFCS) Level II	65.1	± 12.4
Gross Motor Function Classification System (GMFCS) Level III	62.3	± 12.6
Gross Motor Function Classification System (GMFCS) Level IV	55.8	± 10.5
Gross Motor Function Classification System (GMFCS) Level V	54.0	± 12.5

Participation, Baseline 6yrs+

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	70.2	± 15.4
Gross Motor Function Classification System (GMFCS) Level II	63.9	± 12.7
Gross Motor Function Classification System (GMFCS) Level III	62.6	± 10.9
Gross Motor Function Classification System (GMFCS) Level IV	58.9	± 12.9
Gross Motor Function Classification System (GMFCS) Level V	52.4	± 9.7

Participation, 6-month assessment:<6yrs

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	67.9	± 13.6
Gross Motor Function Classification System (GMFCS) Level II	67.7	± 12.6
Gross Motor Function Classification System (GMFCS) Level III	57.8	± 8.8
Gross Motor Function Classification System (GMFCS) Level IV	57.3	± 9.3
Gross Motor Function Classification System (GMFCS) Level V	53.9	± 17.1

Participation, 6-month assessment 6yrs+

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	70.0	± 15.5
Gross Motor Function Classification System (GMFCS) Level II	61.4	± 12.9
Gross Motor Function Classification System (GMFCS) Level III	63.0	± 12.6
Gross Motor Function Classification System (GMFCS) Level IV	60.2	± 12.4
Gross Motor Function Classification System (GMFCS) Level V	50.0	± 9.8

Participation, 12-month assessment: <6yrs

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	70.3	± 13.3
Gross Motor Function Classification System (GMFCS) Level II	64.2	± 12.6
Gross Motor Function Classification System (GMFCS) Level III	62.3	± 9.7
Gross Motor Function Classification System (GMFCS) Level IV	56.1	± 9.9
Gross Motor Function Classification System (GMFCS) Level V	52.1	± 9.8

Participation, 12-month assessment: 6yrs+

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	70.3	± 14.1
Gross Motor Function Classification System (GMFCS) Level II	64.1	± 13.1
Gross Motor Function Classification System (GMFCS) Level III	62.1	± 12.5
Gross Motor Function Classification System (GMFCS) Level IV	58.1	± 10.8
Gross Motor Function Classification System (GMFCS) Level V	50.5	± 9.9

Participation, 18-month assessment: <6yrs

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	69.7	± 12.5
Gross Motor Function Classification System (GMFCS) Level II	66.5	± 14.2
Gross Motor Function Classification System (GMFCS) Level III	65.4	± 10.5
Gross Motor Function Classification System (GMFCS) Level IV	58.6	± 10.2
Gross Motor Function Classification System (GMFCS) Level V	54.0	± 14.1

Participation, 18-month assessment 6yrs+

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	69.3	± 13.7
Gross Motor Function Classification System (GMFCS) Level II	64.8	± 14.2
Gross Motor Function Classification System (GMFCS) Level III	58.3	± 9.2
Gross Motor Function Classification System (GMFCS) Level IV	58.0	± 11.2
Gross Motor Function Classification System (GMFCS) Level V	48.4	± 11.2

Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care Primary · up to 24-months

CEDL is a 40-item caregiver-completed questionnaire to estimate children's participation. Part 2 measures self-care, defined as the degree that the child participates in daily feeding, dressing, bathing, and toileting. Part 2 is scored on a 5-point Likert scale from 1= 'does not do the activity' to 5= 'does the activity independently most of the time'. The scale distinguishes the need for physical assistance from a person, the ability to complete the activity under various conditions, and the amount of the activity able to complete. A Rasch analysis has converted scores into 0-100 scaled score

Self-care, Baseline: <6yrs

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	54.4	± 12.5
Gross Motor Function Classification System (GMFCS) Level II	49.0	± 9.7
Gross Motor Function Classification System (GMFCS) Level III	44.4	± 10.0
Gross Motor Function Classification System (GMFCS) Level IV	33.6	± 14.6
Gross Motor Function Classification System (GMFCS) Level V	16.1	± 12.3

Self-care, Baseline: 6yrs+

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	73.0	± 14.4
Gross Motor Function Classification System (GMFCS) Level II	62.1	± 13.5
Gross Motor Function Classification System (GMFCS) Level III	55.3	± 9.3
Gross Motor Function Classification System (GMFCS) Level IV	35.8	± 15.5
Gross Motor Function Classification System (GMFCS) Level V	13.6	± 15.1

Self-care, 6-month assessment: <6yrs

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	56.3	± 11.4
Gross Motor Function Classification System (GMFCS) Level II	50.6	± 8.8
Gross Motor Function Classification System (GMFCS) Level III	44.0	± 8.8
Gross Motor Function Classification System (GMFCS) Level IV	34.0	± 14.5
Gross Motor Function Classification System (GMFCS) Level V	15.6	± 13.6

Self-care, 6-month assessment: 6yrs+

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	72.1	± 12.7
Gross Motor Function Classification System (GMFCS) Level II	63.7	± 15.8
Gross Motor Function Classification System (GMFCS) Level III	56.0	± 10.9
Gross Motor Function Classification System (GMFCS) Level IV	37.6	± 16.1
Gross Motor Function Classification System (GMFCS) Level V	12.1	± 14.8

Self-care, 12-month assessment: <6yrs

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	61.8	± 12.7
Gross Motor Function Classification System (GMFCS) Level II	54.0	± 10.5
Gross Motor Function Classification System (GMFCS) Level III	47.1	± 8.2
Gross Motor Function Classification System (GMFCS) Level IV	37.3	± 11.8
Gross Motor Function Classification System (GMFCS) Level V	16.5	± 13.4

Self-care, 12-month assessment: 6yrs+

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	76.3	± 14.8
Gross Motor Function Classification System (GMFCS) Level II	64.5	± 14.9
Gross Motor Function Classification System (GMFCS) Level III	59.2	± 13.4
Gross Motor Function Classification System (GMFCS) Level IV	36.9	± 17.6
Gross Motor Function Classification System (GMFCS) Level V	13.1	± 16.1

Self-care, 18-month assessment: <6yrs

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	61.4	± 14.0
Gross Motor Function Classification System (GMFCS) Level II	50.7	± 12.6
Gross Motor Function Classification System (GMFCS) Level III	46.7	± 7.2
Gross Motor Function Classification System (GMFCS) Level IV	38.0	± 14.4
Gross Motor Function Classification System (GMFCS) Level V	18.1	± 13.6

Self-care, 18-month assessment: 6yrs+

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	75.2	± 15.1
Gross Motor Function Classification System (GMFCS) Level II	65.9	± 16.8
Gross Motor Function Classification System (GMFCS) Level III	59.3	± 13.1
Gross Motor Function Classification System (GMFCS) Level IV	37.1	± 18.2
Gross Motor Function Classification System (GMFCS) Level V	13.6	± 15.4

Services Questionnaire Primary · up to 24-months

The Services questionnaire is a caregiver-completed measure of the medical and rehabilitation services provided to the child in the period since the last data collection point. The variables used for the analysis of the relationship between services and four outcomes are reported. These data are: mean amount of physical, occupational, and speech and language therapy service sessions per year (recorded in 5 ordinal intensity times/year categories: 1=0-1, 2=2-30, 3=31-52, 4=53-155, 5=\>156), mean family centeredness across 14 items (scored in 5 ordinal categories: 1=not at all, 2=small, 3=modera

Intensity of services: PT Baseline

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	2.2	± 0.8
Gross Motor Function Classification System (GMFCS) Level II	2.5	± 1.0
Gross Motor Function Classification System (GMFCS) Level III	2.8	± 0.9
Gross Motor Function Classification System (GMFCS) Level IV	2.9	± 1.0
Gross Motor Function Classification System (GMFCS) Level V	2.9	± 1.0

Intensity of services: PT 6M

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	2.2	± 0.9
Gross Motor Function Classification System (GMFCS) Level II	2.8	± 1.0
Gross Motor Function Classification System (GMFCS) Level III	3.3	± 1.0
Gross Motor Function Classification System (GMFCS) Level IV	3.2	± 1.0
Gross Motor Function Classification System (GMFCS) Level V	3.2	± 1.0

Intensity of services: PT 12M

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	2.0	± 0.9
Gross Motor Function Classification System (GMFCS) Level II	2.6	± 1.1
Gross Motor Function Classification System (GMFCS) Level III	3.0	± 1.0
Gross Motor Function Classification System (GMFCS) Level IV	3.0	± 1.0
Gross Motor Function Classification System (GMFCS) Level V	2.9	± 1.1

Intensity of services: PT 18M

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	2.1	± 1.1
Gross Motor Function Classification System (GMFCS) Level II	2.7	± 1.2
Gross Motor Function Classification System (GMFCS) Level III	3.0	± 1.1
Gross Motor Function Classification System (GMFCS) Level IV	3.2	± 1.0
Gross Motor Function Classification System (GMFCS) Level V	3.1	± 1.0

Intensity of services: PT 24M

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	2.0	± 1.0
Gross Motor Function Classification System (GMFCS) Level II	2.8	± 1.1
Gross Motor Function Classification System (GMFCS) Level III	3.0	± 1.1
Gross Motor Function Classification System (GMFCS) Level IV	3.3	± 1.0
Gross Motor Function Classification System (GMFCS) Level V	3.0	± 1.0

Intensity of services: OT Baseline

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	2.0	± 0.8
Gross Motor Function Classification System (GMFCS) Level II	2.2	± 0.9
Gross Motor Function Classification System (GMFCS) Level III	2.3	± 0.9
Gross Motor Function Classification System (GMFCS) Level IV	2.6	± 0.8
Gross Motor Function Classification System (GMFCS) Level V	2.6	± 1.0

Intensity of services: OT 6M

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	2.1	± 0.9
Gross Motor Function Classification System (GMFCS) Level II	2.5	± 1.0
Gross Motor Function Classification System (GMFCS) Level III	2.6	± 1.1
Gross Motor Function Classification System (GMFCS) Level IV	2.8	± 1.0
Gross Motor Function Classification System (GMFCS) Level V	2.8	± 1.1

Intensity of services: OT 12M

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	2.0	± 1.0
Gross Motor Function Classification System (GMFCS) Level II	2.2	± 1.0
Gross Motor Function Classification System (GMFCS) Level III	2.5	± 1.1
Gross Motor Function Classification System (GMFCS) Level IV	2.6	± 0.9
Gross Motor Function Classification System (GMFCS) Level V	2.5	± 1.1

Percentage of All Participants According to Gross Motor Function Classification System (GMFCS) Secondary · Baseline

The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations; II: Walks with limitations; III: Walks using a hand-held mobility device; IV: Self-mobility with limitations; may use powered mobility; and V: Transported in manual wheelchair. Descriptors for the five levels vary by age of the child. Children were classified by consensus between parents and assessing therapists by comparing the child's fun

GMFCS Level I

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	32.1

GMFCS Level II

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	22.7

GMFCS Level III

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	11.3

GMFCS Level IV

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	18.2

GMFCS Level V

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	15.7

Manual Ability Classification System (MACS) Secondary · Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)

The MACS is a classification system based on functional hand movement ability. MACS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions for each level are: I: Handles objects easily \& effectively; II: Handles most objects with somewhat reduced quality and/or speed; III: Handles objects with difficulty, needs help to prepare and/or modify activities; IV: Handles a limited selection of easily managed objects; and V: Does not handle objects and has severely limited ability to perform even simple actions.

MACS Level I

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	95
Gross Motor Function Classification System (GMFCS) Level II	33
Gross Motor Function Classification System (GMFCS) Level III	12
Gross Motor Function Classification System (GMFCS) Level IV	4
Gross Motor Function Classification System (GMFCS) Level V	0

MACS Level II

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	121
Gross Motor Function Classification System (GMFCS) Level II	96
Gross Motor Function Classification System (GMFCS) Level III	40
Gross Motor Function Classification System (GMFCS) Level IV	21
Gross Motor Function Classification System (GMFCS) Level V	2

MACS Level III

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	9
Gross Motor Function Classification System (GMFCS) Level II	24
Gross Motor Function Classification System (GMFCS) Level III	21
Gross Motor Function Classification System (GMFCS) Level IV	49
Gross Motor Function Classification System (GMFCS) Level V	4

MACS Level IV

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	2
Gross Motor Function Classification System (GMFCS) Level II	8
Gross Motor Function Classification System (GMFCS) Level III	6
Gross Motor Function Classification System (GMFCS) Level IV	49
Gross Motor Function Classification System (GMFCS) Level V	52

MACS Level V

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	0
Gross Motor Function Classification System (GMFCS) Level II	0
Gross Motor Function Classification System (GMFCS) Level III	1
Gross Motor Function Classification System (GMFCS) Level IV	6
Gross Motor Function Classification System (GMFCS) Level V	53

Communication Function Classification System (CFCS) Secondary · Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)

The CFCS is a classification system based on functional communication ability. CFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions for each level are: I: Effective sender/receiver with familiar/unfamiliar partners; II: Effective but slower paced sender and/or receiver with familiar/unfamiliar partners; III: Effective sender \& receiver with familiar partners; IV: Inconsistent sender and/or receiver with familiar partners; and V: Seldom effective sender \& receiver with familiar partners.

CFCS Level I

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	144
Gross Motor Function Classification System (GMFCS) Level II	63
Gross Motor Function Classification System (GMFCS) Level III	34
Gross Motor Function Classification System (GMFCS) Level IV	20
Gross Motor Function Classification System (GMFCS) Level V	3

CFCS Level II

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	46
Gross Motor Function Classification System (GMFCS) Level II	46
Gross Motor Function Classification System (GMFCS) Level III	17
Gross Motor Function Classification System (GMFCS) Level IV	16
Gross Motor Function Classification System (GMFCS) Level V	1

CFCS Level III

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	26
Gross Motor Function Classification System (GMFCS) Level II	28
Gross Motor Function Classification System (GMFCS) Level III	18
Gross Motor Function Classification System (GMFCS) Level IV	38
Gross Motor Function Classification System (GMFCS) Level V	24

CFCS Level IV

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	10
Gross Motor Function Classification System (GMFCS) Level II	23
Gross Motor Function Classification System (GMFCS) Level III	9
Gross Motor Function Classification System (GMFCS) Level IV	45
Gross Motor Function Classification System (GMFCS) Level V	42

CFCS Level V

Group	Value	95% CI
Gross Motor Function Classification System (GMFCS) Level I	1
Gross Motor Function Classification System (GMFCS) Level II	1
Gross Motor Function Classification System (GMFCS) Level III	2
Gross Motor Function Classification System (GMFCS) Level IV	10
Gross Motor Function Classification System (GMFCS) Level V	41

Sponsor's own description

The On Track Study is a large multi-site collaboration involving researchers, therapists, families, and children with cerebral palsy (CP) from across Canada and the United States. The researchers need to better understand how young children who have difficulties with movement activities progress and develop in their balance abilities, fitness, strength, health, range of motion, self-care, everyday play, and activity participation. This study will determine how young children with cerebral palsy or gross motor delays progress in many aspects of their physical development and participation in daily life. The information collected from this study will help therapists and parents monitor if a child is developing as expected in his or her physical development and participation. Then, the health care professionals working with children can use the results of this study, in combination with the previously completed Move \& PLAY study results, to provide the services that are most beneficial and meaningful for each child and their family members.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02391948 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 19 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02391948.

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NCT02391948

Quick facts

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Cerebral Palsy

Other University of Washington trials

Verify against primary sources