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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07111091
Enrollment
19
Registered
2025-08-08
Start date
2019-12-19
Completion date
2024-12-24
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERGAIT 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

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
balanceFrom enrollment to the end of treatment at 4 weeksBalance 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

MeasureTime frameDescription
demographic information formFrom enrollment to the end of treatment at 4 weeksOrthosis information, including participants' full name, age, gender, weight, height, affected side, lower extremity length, and duration of orthosis use, was recorded.
Gait assessmentsFrom enrollment to the end of treatment at 4 weeksIn 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026