Effect of Ankle-Foot Orthosis on Gait and Balance in Children With Hemiparatic Cerebral Palsy (NCT07111091) | Clinical Trial Compass
CompletedNot Applicable
Effect of Ankle-Foot Orthosis on Gait and Balance in Children With Hemiparatic Cerebral Palsy
Turkey (Türkiye)19 participantsStarted 2019-12-19
Plain-language 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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically about children with hemiparetic cerebral palsy — does my child's type and severity of CP match the profile of the children who were included in this research?
2Since this trial has already been completed and was measuring balance as its primary outcome, has the data been published yet, and if so, what did it actually show about whether ankle-foot orthoses improved balance in kids like mine?
3My child already has or has been recommended an AFO — does the evidence from a study like this change your recommendation about the specific type of AFO or how it should be fitted for their particular gait pattern?
4This was listed as Phase NA, which I understand often means it's an observational or device study rather than a drug trial — does that mean the main risk here was just wearing the AFO itself, and are there any risks from AFO use my child could still experience?
5Are there other current or upcoming studies on AFOs and gait in children with hemiparetic CP that might offer my child access to newer evaluation tools or interventions alongside standard care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
balance
Timeframe: From enrollment to the end of treatment at 4 weeks