Investigation of the Effect of Elastic Lower Extremity Orthosis on Gait and Balance Parameters in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
Phase: NA
Conditions: Spastic Cerebral Palsy
Sponsor: Gazi University

Official Study Title: Investigation of the Effect of Elastic Lower Extremity Orthosis on 
Gait and Balance Parameters in Children With Spastic Cerebral Palsy: A Randomized 
Controlled Trial 
 
ClinicalTrials.gov Identifier: NCT07122362 
 
Document Date: April 19, 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Brief Title: Effect of Elastic Lower Extremity Orthosis on Gait and Balance Parameters 
in Children with Spastic Cerebral Palsy 
Study Period: Start: August 25 2025– End: November 01 2025 
1. Study Objective 
The primary objective of this study is to determine the effect of an elastic lower extremity 
orthosis, applied in addition to conventional neurodevelopmental treatment, on gait and 
balance parameters in children with spastic cerebral palsy presenting with an in-toeing gait 
pattern. 
2. Study Design 
Single-blind randomized controlled trial 
Biostatistician will be blinded to group allocation 
Groups will be assigned using simple randomization 
3. Study Population 
Inclusion Criteria 
Voluntary participation 
Diagnosis of spastic cerebral palsy 
GMFCS level 1–3 
Age 18–84 months 
Written and verbal informed consent from parents 
Exclusion Criteria 
GMFCS level 4–5 
Botulinum toxin injection or surgery to lower extremities/pelvis in the past 6 months 
Sample Size 
Each group: 13 participants 
Total: 26 participants 
Calculated using G*Power with 95% power and α = 0.05 
4. Intervention 
Neoprene elastic lower extremity orthosis 
7 days per week, 6–8 hours per day, 8 weeks 
In addition to conventional neurodevelopmental therapy 

5. Data Collection and Measurements 
Demographics: age, sex, height, weight, CP type, GMFCS level 
Gait: Edinburgh Visual Gait Analysis (17 parameters) 
Balance: Pediatric Balance Scale (14 items, 0–4 points) 
Measurements at baseline and after 8 weeks 
Video recordings obtained 
No personal identifying information included