Impact of AFOs on the GMF of Children With CP or ABI

April 8, 2025 updated by: Kaat Desloovere, Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Pellenberg, Belgium, 3212
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Severe contractures or spasticity, which makes it impossible to wear an AFO.
  • Cognitive or visual impairment that limits the participation of the GMFM-88.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Minimal 1 days and maximal 7 days between the two measurements and at similar moments during the day.
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.
Minimal 1 days and maximal 7 days between the two measurements and at similar moments during the day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kaat Desloovere, Prof. dr., Department of Rehabilitation Sciences, KU Leuven, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • s65042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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