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

NCT06930963 | Completed

• 1 other identifier: s65042
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spastic Cerebral Palsy (sCP); Acquired Brain Injury

Keywords

Cerebral palsy; Gross motor function; Ankle-foot orthosis

Outcome Measures

Primary Outcomes (2)

• The GMFM-88 scores

  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

  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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven

Pellenberg, 3212, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kaat Desloovere, Prof. dr.

  Department of Rehabilitation Sciences, KU Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: March 31, 2021
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

BE (1)