NCT03662139

Dynamic Gait Index in Hemiplegic Cerebral Palsy

Completed Results posted Last updated 29 January 2020

What this trial tests

trial testing Dynamic Gait Index in Cerebral Palsy in 32 participants. Completed in 1 December 2018.

Timeline

1 April 2018

Primary endpoint
30 June 2018

1 December 2018

Quick facts

Lead sponsor	Marmara University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	32
Start date	1 April 2018
Primary completion	30 June 2018
Estimated completion	1 December 2018
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Dynamic Gait Index

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →
• Hemiplegic Cerebral Palsy — all drugs for Hemiplegic Cerebral Palsy →
• Gait Disorders, Neurologic — all drugs for Gait Disorders, Neurologic →

Sponsor

Marmara University

Who can join

Adults 6 to 14, any sex, with Cerebral Palsy or Hemiplegic 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.

Dynamic Gait Index (DGI) Primary · Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only

Dynamic Gait Index is a tool consisting eight items; gait on a flat surface, changing speed, gait with horizontal and vertical head turns, pivot turn, stepping over obstacle, Minimum score is 0, maximum score is 24, higher scores indicate better outcome. Scores lower than 19 indicate risk of falling and above 22 define safe ambulance.

1. Assessment

Group	Value	95% CI
Cerebral Palsy Group	19	8 – 23
Healthy Control Group	24	23 – 24

2. Assessment

Group	Value	95% CI
Cerebral Palsy Group	18.5	10 – 23

Pediatric Balance Scale (PBS) Secondary · Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)

Pediatric Balance Scale is a functional balance scale adapted and customized from Berg Balance Scale for use with children. Pediatric Balance Scale is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks. It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. Minimum score is 0, maximum score is 56; higher scores indicat

1. Assessment

Group	Value	95% CI
Cerebral Palsy Group	49.5	39 – 54
Healthy Control Group	56	53 – 56

2. Assessment

Group	Value	95% CI
Cerebral Palsy Group	50	39 – 54

Timed Up and Go Test (TUG) Secondary · Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)

TUG is a test determining fall risk and balance by their physical performance in sitting to standing, and walking. Test begins with the patient sitting back in a standart chair and when asked walking 10 feets on a certain line than back to the chair sitting. Completion time is recorded for the task and longer time indicates worse ambulation and higher risk of fall.

1. Assessment

Group	Value	95% CI
Cerebral Palsy Group	10	5.87 – 16.22
Healthy Control Group	6.97	5.15 – 8.42

2. Assessment

Group	Value	95% CI
Cerebral Palsy Group	8.72	6.16 – 14.23

Four Square Step Test (FSST) Secondary · Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)

FSST, assesses dynamic balance and coordination through stepping forwards, sideways, and backwards in a timed fashion. It is a valid and reliable tool in children with cerebral palsy. The test requires the participant to step forwards, backwards and sideways over four-square shaped line in a specified sequence. Completion time is recorded for the task and longer time indicates worse ambulation and higher risk of fall.

1. Assessment

Group	Value	95% CI
Cerebral Palsy Group	11.85	8.35 – 40.38
Healthy Control Group	7.33	6.25 – 10.20

2. Assessment

Group	Value	95% CI
Cerebral Palsy Group	10.21	7.42 – 38.42

Sponsor's own description

The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI) in patients with unilateral spastic cerebral palsy

Publications & conference data

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