Effect of Elastic Lower Extremity Orthosis on Gait and Balance in Children With Spastic Cerebral Palsy

Not Applicable

Not yet recruiting

• Conditions: Spastic Cerebral Palsy

• Registration Number: NCT07122362
• Lead Sponsor: Gazi University

Brief Summary

This randomized controlled trial aims to evaluate the effect of an elastic lower extremity orthosis on gait and balance in children with spastic cerebral palsy who present with an in-toeing gait pattern. The study compares conventional neurodevelopmental therapy alone to therapy combined with the orthosis.

Detailed Description

Cerebral palsy (CP) is a group of permanent disorders affecting movement and posture and is one of the most common causes of motor disability in children. One of the most frequent rotational gait abnormalities in children with spastic CP is in-toeing, which may result from increased femoral anteversion, internal tibial torsion, or foot deformities such as metatarsus varus or metatarsus adductus.

Elastic orthoses wrapped around the femoral region can generate active rotational forces and help modify the foot progression angle during gait. In early childhood, elastic external rotation straps starting from the foot can also be used for tibial rotation problems.

This randomized controlled trial will compare the effects of conventional neurodevelopmental therapy alone with therapy combined with the use of an elastic lower extremity orthosis.

Primary outcome measure: Gait parameters

Secondary outcome measure: Balance parameters

The study hypothesizes that the group receiving the orthosis in addition to conventional therapy will demonstrate superior outcomes in terms of gait and balance compared to the control group.

Study Timeline

• Study First Submitted: 2025-07-30
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-08-25
• Primary Completion: 2025-10-20
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Voluntary participation
• Diagnosis of spastic cerebral palsy
• Gross Motor Function Classification System (GMFCS) level 1, 2, or 3
• Age between 18 and 84 months
• Presence of in-toeing gait pattern

Exclusion Criteria

• GMFCS level 4 or 5
• Botulinum toxin injection or surgical intervention targeting the lower extremities or pelvis within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait parameters assessed by Edinburgh Visual Gait Analysis	Baseline and 8 weeks after intervention	The Edinburgh Visual Gait Analysis Scale will be used to assess changes in gait patterns before and after the intervention. This scale consists of 17 items. Each item is scored between 0 and 2. A total score closer to zero indicates improved gait. The Edinburgh Visual Gait Analysis Scale was developed to quantitatively analyze gait parameters at different stages in recorded videos. During the assessment, children will be videotaped walking on a flat surface with their lower extremities bare. These recordings will assess each lower extremity during the stance and swing phases of gait.

Secondary Outcome Measures

Name	Time	Method
Balance parameters assessed by Pediatric Balance Scale	Baseline and 8 weeks after intervention	The Pediatric Balance Scale will be used to assess balance performance and changes in balance ability at baseline and 8 weeks after the intervention. The 14-item Pediatric Balance Scale is a functional balance measurement tool adapted for the pediatric population and allows for the assessment of balance in various positions and during movement; each item is scored from 0 to 4, with the highest possible score being 56. A higher score indicates better balance.

Trial Locations

Locations (2)

Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Turkey; 🇹🇷 Ankara, Turkey

Niğde Ömer Halisdemir University Bor Physical Therapy and Rehabilitation Training and Research Hospital; 🇹🇷 Niğde, Turkey