Cerebral Palsy (CP)NCT07111091
Effect of Ankle-Foot Orthosis on Gait and Balance in Children With Hemiparatic Cerebral Palsy
A study testing GAIT AND BALANCE EVALUATION in people with Cerebral Palsy (CP) and Hemiparatic Cerebral Palsy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Hemiparatic Cerebral Palsy, Balance
- What is being tested?
- GAIT AND BALANCE EVALUATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2019to 24 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- foot deformity
- using walking aids
- unable to walk independently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Unilateral and Bilateral Plastic 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.
Read more
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)
- Being tested
- GAIT AND BALANCE EVALUATION
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAIT AND BALANCE EVALUATIONOther
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.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Other | Not described Receives: Other: GAIT AND BALANCE EVALUATION |
| GROUP B | Other | Not described Receives: Other: GAIT AND BALANCE EVALUATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (2)
demographic information form
Orthosis information, including participants' full name, age, gender, weight, height, affected side, lower extremity length, and duration of orthosis use, was recorded.
Measured: From enrollment to the end of treatment at 4 weeks
Gait assessments
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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start19 Dec 2019
- Primary completion21 Mar 2021
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yılmaz, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111091
- Sponsor's protocol ID
- 10840098604.01.01-E.56252
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Unilateral and Bilateral Plastic Ankle Foot Orthosis on Gait and Balance in Children With Hemiparatic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07111091
- Acronym / sponsor ID
- 10840098604.01.01-E.56252
- Conditions
- Cerebral Palsy (CP), Hemiparatic Cerebral Palsy, Balance, Gait Analysis, Ankle Foot Orthosis (AFO)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Other | Other: GAIT AND BALANCE EVALUATION |
| GROUP B | Other | Other: GAIT AND BALANCE EVALUATION |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- foot deformity
- using walking aids
- unable to walk independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAIT AND BALANCE EVALUATIONIn 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. | Other | GROUP A, GROUP B |
Primary outcome
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.
2 secondary outcomes
demographic information form
Time frame: From enrollment to the end of treatment at 4 weeks
Gait assessments
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAIT AND BALANCE EVALUATION in people with Cerebral Palsy (CP) and Hemiparatic Cerebral Palsy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.