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Completed

NCT Number: NCT07111091

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

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.

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Key information

Conditions

Cerebral Palsy (CP) Ankle Foot Orthosis (AFO) Balance Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Gait Analysis Hemiparatic Cerebral Palsy Nervous System Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. balance

    Time frame: From enrollment to the end of treatment at 4 weeks

    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.

Secondary outcomes

  1. demographic information form

    Time frame: From enrollment to the end of treatment at 4 weeks

    Orthosis information, including participants' full name, age, gender, weight, height, affected side, lower extremity length, and duration of orthosis use, was recorded.

  2. Gait assessments

    Time frame: From enrollment to the end of treatment at 4 weeks

    In our study, participants' gait assessments were conducted using a GAITRite electronic walking path. Participants walked at a self-selected speed on a stable surface, while time and distance characteristics were recorded.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Comparison of the Effects of Unilateral and Bilateral Plastic Ankle Foot Orthosis on Gait and Balance in Children With Hemiparatic Cerebral Palsy

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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