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

NCT07111091 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-08-08

No results posted yet for this study

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)

Interventions

OTHER

GAIT AND BALANCE EVALUATION

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.

Sponsors & Collaborators

  • Istanbul Medipol University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2021-03-21
Completion
2024-12-24

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111091 on ClinicalTrials.gov