NCT03122171

Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy

Completed NA Results posted Last updated 20 November 2020

What this trial tests

NA trial testing Occupational Therapy Treatment in Cerebral Palsy in 6 participants. Completed in 13 January 2020.

Timeline

1 April 2017

Primary endpoint
13 January 2020

13 January 2020

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	6
Start date	1 April 2017
Primary completion	13 January 2020
Estimated completion	13 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Occupational Therapy Treatment

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →
• Prosthesis User — all drugs for Prosthesis User →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 4 to 17, any sex, with Cerebral Palsy or Prosthesis User. 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.

Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score Primary · Week 8

The Assisting Hand Assessment (AHA) is a test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance. An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session. Scores based on 22-items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective). The range of sum scores is 22-88 points. A clinical significant increase in score indicates an increase in quality of performance.

Group	Value	95% CI
Prosthesis	4

Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment Primary · 8 weeks

The PMAL is a structured interview in which the caregiver reports "How Often" (amount) and "How Well" (quality of movement) the child uses their involved upper limb when completing 22 activities of daily living. Scores range from 0-10; the higher the score, the better the quality of movement. An increase in PMAL score indicates a higher amount of upper extremity use and better quality of movement.

Group	Value	95% CI
Prosthesis	4

Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores Primary · Week 8

The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of motion, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement. An increase in score indicates an increase in upper limb movement quality.

Range of Motion

Group	Value	95% CI
Prosthesis	4

Accuracy of Reach and Placement

Group	Value	95% CI
Prosthesis	3

Dexterity of Grasp

Group	Value	95% CI
Prosthesis	3

Fluency of Movement

Group	Value	95% CI
Prosthesis	2

Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment Secondary · 8 weeks

The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. 7 sub-tests will be reported on. Higher scores indicate better HRQOL (Health-Related Quality of Life), an increase in score indicates an increase in HRQOL.

Daily Activities

Group	Value	95% CI
Prosthesis	3

School Activities

Group	Value	95% CI
Prosthesis	3

Movement and Balance

Group	Value	95% CI
Prosthesis	3

Pain and Hurt

Group	Value	95% CI
Prosthesis	2

Fatigue

Group	Value	95% CI
Prosthesis	1

Eating Activities

Group	Value	95% CI
Prosthesis	1

Speech and Communication

Group	Value	95% CI
Prosthesis	1

Sponsor's own description

The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in improving the upper extremity function of children with cerebral palsy who have limited use of their hands. Twelve children, aged 4-17 years, who have cerebral palsy and limitations in their ability to use their hands, will be enrolled. All participants will be fitted with a 3D printed arm/hand prosthesis and receive 8 occupational therapy sessions. Each subject will be evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up. The evaluation will include assessment of (1)passive and active arm/hand movement and (2)functional hand skills using several standardized tests. The results from the pre-treatment and the two post-treatment evaluations will be compared.

Publications & conference data

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