Effect of Ankle-Foot Orthosis on Gait and Balance in Children With Hemiparatic Cerebral Palsy
NCT ID: NCT07111091
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2019-12-19
2024-12-24
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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GROUP A
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.
GROUP B
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* using walking aids
* unable to walk independently
4 Years
12 Years
ALL
No
Sponsors
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Istanbul Medipol University Hospital
OTHER
Responsible Party
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merve yılmaz
Istanbul Medipol University
Locations
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Istanbul Medipol University
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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10840098604.01.01-E.56252
Identifier Type: -
Identifier Source: org_study_id
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