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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Belgium1 site
  • UZLeuven

    Pellenberg, 3212

Other trials in Belgium

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 groups in NCT06930963
Study groupRoleWhat they receive
Ambulatory children with CP or ABIAmbulant 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.

  1. 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.

  2. 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.

  1. First posted16 Apr 2025
  2. Study start31 Mar 2021
  3. Primary completion16 Feb 2023
  4. Study completion16 Feb 2023

Resources

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)
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

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.

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