Effect of Elastic Lower Extremity Orthosis on Gait and Balance in Children With Spastic Cerebral Palsy
Investigation of the Effect of Elastic Lower Extremity Orthosis on Gait and Balance Parameters in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
1 other identifier
interventional
26
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2025
CompletedFirst Posted
Study publicly available on registry
August 14, 2025
CompletedStudy Start
First participant enrolled
August 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJanuary 6, 2026
August 1, 2025
2 months
July 30, 2025
January 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gait parameters assessed by Edinburgh Visual Gait Analysis
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.
Baseline and 8 weeks after intervention
Secondary Outcomes (1)
Balance parameters assessed by Pediatric Balance Scale
Baseline and 8 weeks after intervention
Study Arms (2)
Control Group: Neurodevelopmental Therapy
ACTIVE COMPARATORParticipants receive conventional neurodevelopmental therapy only.
Intervention Group: Therapy + Elastic Orthosis
EXPERIMENTALParticipants receive conventional neurodevelopmental therapy plus elastic lower extremity orthosis.
Interventions
Participants in the intervention group receive conventional neurodevelopmental therapy combined with an elastic lower extremity orthosis designed to correct internal rotation deformities and improve gait and balance in children with spastic cerebral palsy. The orthosis applies elastic tension around the femoral region and tibia to target rotational problems.
Participants receive conventional neurodevelopmental therapy only.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- GMFCS level 4 or 5
- Botulinum toxin injection or surgical intervention targeting the lower extremities or pelvis within the last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (2)
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Turkey
Ankara, Ankara, 06000, Turkey (Türkiye)
Niğde Ömer Halisdemir University Bor Physical Therapy and Rehabilitation Training and Research Hospital
Niğde, Niğde Province, 51000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
BÜLENT ELBASAN, Prof.
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Türkiye
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 30, 2025
First Posted
August 14, 2025
Study Start
August 25, 2025
Primary Completion
October 20, 2025
Study Completion
November 1, 2025
Last Updated
January 6, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Individual participant data and supporting documents will be available starting 6 months after study completion and will remain available for at least 5 years.
- Access Criteria
- Qualified researchers with appropriate ethics committee approval may request access to the de-identified IPD and supporting documents. Data will be shared following a data sharing agreement that ensures confidentiality and appropriate use. Access requests can be made by contacting the corresponding
De-identified individual participant data (IPD) will be made available upon reasonable request from qualified researchers with ethics approval, starting 6 months after study completion. Data sharing will be conducted under a data sharing agreement to ensure participant confidentiality.