Spastic Cerebral Palsy (sCP)NCT06930963
Impact of AFOs on the GMF of Children With CP or ABI
An observational study of Spastic Cerebral Palsy (sCP) and Acquired Brain Injury, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Children with cerebral palsy (CP) or an acquired brain injury (ABI) are often prescribed ankle-foot orthoses (AFOs) to correct impairments of muscles and/or to prevent contractures and bony deformities. The impact of AFOs on gait, and to a lesser extent on gross motor function (GMF), has been investigated. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Spastic Cerebral Palsy (sCP), Acquired Brain Injury
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2021to 16 Feb 2023
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Ambulant children with cerebral palsy between 6 and 18 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.
Who may be able to join
- Gross Motor Function Classification System (GMFCS) level I - III
- CP or ABI
- Age: 6 - 18 years
- Prescribed AFO by the medical team (as part of the standard care)
Who cannot join
- Severe contractures or spasticity, which makes it impossible to wear an AFO.
- Cognitive or visual impairment that limits the participation of the GMFM-88.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the Ankle-foot Orthoses on the Gross Motor Function of Children With Neurological Disorders
Children with cerebral palsy (CP) or an acquired brain injury (ABI) are often prescribed ankle-foot orthoses (AFOs) to correct impairments of muscles and/or to prevent contractures and bony deformities. The impact of AFOs on gait, and to a lesser extent on gross motor function (GMF), has been investigated. Yet, little is known about their impact on the quality of movement. This study aims to examine how AFOs influence both the quality and capacity of daily functional activities in these children.
Read the detailed description
Background:
Children with cerebral palsy (CP) or an acquired brain injury (ABI) often experience similar functional challenges and symptoms, leading to comparable treatment approaches. Enhancing gross motor function (GMF) and gait is a key treatment objective for children with CP or ABI, as these improvements are closely linked to functional independence and social participation. Ankle-foot orthoses (AFOs) are frequently prescribed to support gait, prevent secondary deformities, and compensate for muscle weakness. While existing research indicates that AFOs can enhance GMF capacity in children with CP, their impact on the quality of movement during functional tasks remains insufficiently explored.
Aim:
This study aims to evaluate the impact of AFOs on both the capacity (what children can do) and the quality (how they perform) of GMF in ambulatory children with CP or ABI. Specifically, the research seeks to determine the potential benefits or drawbacks of AFO use on specific functional tasks.
Methods/Study Design:
This prospective study will perform and film two GMFM-88-assessments (one with barefoot \& one with AFOs) on 29 children with CP or ABI. Randomization to define the initial order of the assessment condition (barefoot or AFOs) will be performed by flipping a coin. Furthermore, these measurements will be performed with minimal 2 days and maximal 7 days in between and at similar moments during the day, representing an interval period that is sufficiently long (minimal 2 days) to minimalize possible test-potentiated learning effects and sufficiently short (maximal 7 days) to minimize potential impact of progression in functional skills due to rehabilitation sessions. The capacity of functional skills will be scored using the GMFM-88. The quality of the functional skills will be scored from the video of the GMFM-88 measurement, using the QFM. The videos of the two measurements will be scored separately with a minimal of 2 weeks in between, to minimize patient-specific performance expectations. An independent researcher will create two individual data sets of the recorded videos of the two GMFM-88 measurements (barefoot \& AFO condition). The order in which the videos are divided over the two datasets, will be randomized.
The patients (with ABI or CP) will be recruited through the Cerebral Palsy Reference Center of the University Hospital (UZ) of Leuven (Prof. Dr. Anja Van Campenhout). Our preference goes to patients hospitalized in Pulderbos Revalidatiecentrum voor Kinderen en Jongeren or in UZ Leuven (Gasthuisberg), that are in their final phase of their intensive rehabilitation. Parents and children will be contacted by the involved researcher (Dra. Laure Everaert) via face-to-face conversation at the clinical appointment, via e-mail or by phone with the permission of the supervising medical doctor.
- Keywords
- Cerebral palsy, Gross motor function, Ankle-foot orthosis
- Medical subject headings
- Cerebral Palsy, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory children with CP or ABI | Ambulant children with cerebral palsy or acquired brain injury between 6 and 16 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The GMFM-88 scores
Functional skill capacity will be assessed using the GMFM-88 in two conditions: once barefoot and once with AFOs.
Measured: Minimal 1 days and maximal 7 days between the two measurements and at similar moments during the day.
The QFM scores
The quality of functional skills will be assessed using the QFM, based on video recordings of the GMFM-88 measurements under two conditions: once barefoot and once with AFOs.
Measured: Minimal 1 days and maximal 7 days between the two measurements and at similar moments during the day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start31 Mar 2021
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral Palsy (sCP)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaat Desloovere, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Kaat Desloovere, Prof. dr., Principal investigator, Department of Rehabilitation Sciences, KU Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930963
- Sponsor's protocol ID
- s65042
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Ankle-foot Orthoses on the Gross Motor Function of Children With Neurological Disorders
- ClinicalTrials.gov ID
- NCT06930963
- Acronym / sponsor ID
- s65042
- Keywords
- Cerebral palsy, Gross motor function, Ankle-foot orthosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 16 Apr 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.
Children with cerebral palsy (CP) or an acquired brain injury (ABI) are often prescribed ankle-foot orthoses (AFOs) to correct impairments of muscles and/or to prevent contractures and bony deformities. The impact of AFOs on gait, and to a lesser extent on gross motor function (GMF), has been investigated. Yet, little is known about their impact on the quality of movement. This study aims to examine how AFOs influence both the quality and capacity of daily functional activities in these children.
Detailed description
Background:
Children with cerebral palsy (CP) or an acquired brain injury (ABI) often experience similar functional challenges and symptoms, leading to comparable treatment approaches. Enhancing gross motor function (GMF) and gait is a key treatment objective for children with CP or ABI, as these improvements are closely linked to functional independence and social participation. Ankle-foot orthoses (AFOs) are frequently prescribed to support gait, prevent secondary deformities, and compensate for muscle weakness. While existing research indicates that AFOs can enhance GMF capacity in children with CP, their impact on the quality of movement during functional tasks remains insufficiently explored.
Aim:
This study aims to evaluate the impact of AFOs on both the capacity (what children can do) and the quality (how they perform) of GMF in ambulatory children with CP or ABI. Specifically, the research seeks to determine the potential benefits or drawbacks of AFO use on specific functional tasks.
Methods/Study Design:
This prospective study will perform and film two GMFM-88-assessments (one with barefoot \& one with AFOs) on 29 children with CP or ABI. Randomization to define the initial order of the assessment condition (barefoot or AFOs) will be performed by flipping a coin. Furthermore, these measurements will be performed with minimal 2 days and maximal 7 days in between and at similar moments during the day, representing an interval period that is sufficiently long (minimal 2 days) to minimalize possible test-potentiated learning effects and sufficiently short (maximal 7 days) to minimize potential impact of progression in functional skills due to rehabilitation sessions. The capacity of functional skills will be scored using the GMFM-88. The quality of the functional skills will be scored from the video of the GMFM-88 measurement, using the QFM. The videos of the two measurements will be scored separately with a minimal of 2 weeks in between, to minimize patient-specific performance expectations. An independent researcher will create two individual data sets of the recorded videos of the two GMFM-88 measurements (barefoot \& AFO condition). The order in which the videos are divided over the two datasets, will be randomized.
The patients (with ABI or CP) will be recruited through the Cerebral Palsy Reference Center of the University Hospital (UZ) of Leuven (Prof. Dr. Anja Van Campenhout). Our preference goes to patients hospitalized in Pulderbos Revalidatiecentrum voor Kinderen en Jongeren or in UZ Leuven (Gasthuisberg), that are in their final phase of their intensive rehabilitation. Parents and children will be contacted by the involved researcher (Dra. Laure Everaert) via face-to-face conversation at the clinical appointment, via e-mail or by phone with the permission of the supervising medical doctor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory children with CP or ABI | – | –Ambulant children with cerebral palsy or acquired brain injury between 6 and 16 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Ambulant children with cerebral palsy between 6 and 18 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.
Key inclusion criteria (4 listed)
- Gross Motor Function Classification System (GMFCS) level I - III
- CP or ABI
- Age: 6 - 18 years
- Prescribed AFO by the medical team (as part of the standard care)
Key exclusion criteria (2 listed)
- Severe contractures or spasticity, which makes it impossible to wear an AFO.
- Cognitive or visual impairment that limits the participation of the GMFM-88.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The GMFM-88 scores
Time frame: Minimal 1 days and maximal 7 days between the two measurements and at similar moments during the day.
Functional skill capacity will be assessed using the GMFM-88 in two conditions: once barefoot and once with AFOs.
The QFM scores
Time frame: Minimal 1 days and maximal 7 days between the two measurements and at similar moments during the day.
The quality of functional skills will be assessed using the QFM, based on video recordings of the GMFM-88 measurements under two conditions: once barefoot and once with AFOs.
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 16 Apr 2025.
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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.
Kaat Desloovere, Prof. dr. principal investigator
Department of Rehabilitation Sciences, KU Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Cerebral Palsy (sCP) and Acquired Brain Injury, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 2 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 16 Apr 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 Belgium. 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?
The GMFM-88 scores (time frame: Minimal 1 days and maximal 7 days between the two measurements and at similar moments during the day.). The study lists 2 primary outcomes in all. 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 16 Apr 2025.