Effect of Ankle-Foot Orthosis on Gait and Balance in Children With Hemiparatic Cerebral Palsy

NCT07111091 | Completed

• 1 other identifier: 10840098604.01.01-E.56252
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Ankle-foot orthoses are frequently prescribed to reduce spasticity, position the extremity more properly, and regulate gait during the rehabilitation process of children with cerebral palsy. Objective: To investigate the effects of unilateral or bilateral use of plastic ankle-foot orthoses (AFO) used in children with hemiparetic cerebral palsy (CP) on the child's gait and balance. The aim of this study is to investigate the effects of unilateral and bilateral use of AFOs used in children with hemiparetic cerebral palsy on gait and balance. Methods: 19 cooperative children aged 4-12 years, with gross motor function classification system levels 1 and 2, using bilateral AFOs were included in the study. Children were evaluated with bilateral AFOs, unilateral AFOs, and without AFOs. Trunk sway assessment was performed on the Bertec Balance force platform with eyes open and closed, and time-spatial characteristics of gait were evaluated with the GAITRite electronic walkway.

Conditions

Cerebral Palsy (CP); Hemiparatic Cerebral Palsy; Balance; Gait Analysis; Ankle Foot Orthosis (AFO)

Outcome Measures

Primary Outcomes (1)

• balance

  Balance assessments were conducted using the Bertec Balance Check Screener™ force platform. Oscillations during the assessment were recorded for each participant. For safety reasons, the researcher stood close to the participant without contact during the balance assessment.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (2)

• demographic information form

  From enrollment to the end of treatment at 4 weeks

• Gait assessments

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

GROUP A

OTHER

Other: GAIT AND BALANCE EVALUATION

GROUP B

OTHER

Other: GAIT AND BALANCE EVALUATION

Interventions

GAIT AND BALANCE EVALUATION OTHER

In our study, participants' walking assessments were made with GAITRite electronic walking path (CIR System INC. Clifton. NJ. USA.). In the postural balance assessments of the participants, the Bertec Balance Check Screener™ BP5050 20x20 inch (Bertec Comporation Columbus, OH, USA) force platform was used. The Bertec force platform is a three-component balance platform that is based on objectively measuring instantaneous changes in vertical force and center of pressure (CoP). Bertec was designed to evaluate the ability to maintain balance while standing. The assessments were made in all participants without an orthosis, with unilateral AFO and with bilateral AFO. In our study, participants were given a 10-minute rest period between assessments.

GROUP A; GROUP B

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with Hemiparatic SP
• Cooperative
• Classified as 1 or 2 levels in GMFCS
• Lower extremity muscles with spasticity severity of up to 2 according to Modified Ashworth
• Using Bilateral Plastic AFO Orthosis for the last 6 months

You may not qualify if:

• foot deformity
• using walking aids
• unable to walk independently

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Gait

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Istanbul Medipol University

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: August 8, 2025
• Study Start: December 19, 2019
• Primary Completion: March 21, 2021
• Study Completion: December 24, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)