Gait Profile Score in Children With Cerebral Palsy (CP): Influence of the CP Type, Treatment With Botulinum Injection and Multilevel Surgery

Completed

• Conditions: Cerebral Palsy; Gait Disorders in Children
• Interventions: Other: Gait Profile Score; Other: Gait Visual Score

• Registration Number: NCT06505499
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Instrumented three dimensional gait analysis (3DGA) permits to record spatial, temporal, kinetics, kinematics and electromyographic (EMG) parameters in order to understand gait impairment in children and teenagers with cerebral palsy (CP). Nowadays, single-event multilevel surgery in subjects with CP cannot be performed without 3DGA. However, interpretation of multiple and interdependent data remains complex for the clinician. To address this issue, gait statistical index have been developed to give a single measure of the quality of the gait pattern. Among actual index, the Gait Profile Score (GPS), developed by Baker et al (2009), measure the deviation of kinematics parameters from a controlled dataset. The GPS can be divided in nine Gait Variable Score (GVS), corresponding to major lower limb joints: the MAP (Movement Analysis Profile). Many studies have reported the interest of the GPS to analysis gait of subjects with CP: good inter-session reliability, predictor of postoperative kinematic improvement, minimal clinical threshold calculated at 1.6°, significant relationship with clinical data (joint contractures), and sensibility to change after a single-event multilevel surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-06
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Etiology of cerebral palsy
• Unilateral, bilateral, triplegic or quadriplegic forms of cerebral palsy.
• 6 to 18 years old
• GMFCS (Gross Motor Function Classification System) I to III
• Instrumented gait analysis of the laboratory of St-Etienne
• Absence of botulinum toxin injection or serial casting in the three months after a first instrumented gait analysis.

Exclusion Criteria

• Etiology others than cerebral palsy as defined classically (ex: ischemic infarcts in a child older than two years).
• Previous surgery in lower-limb.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EXPERIMENTAL GROUP	Gait Profile Score	Children and teenagers with CP with an instrumented gait analysis performed since 2019.
EXPERIMENTAL GROUP	Gait Visual Score	Children and teenagers with CP with an instrumented gait analysis performed since 2019.

Primary Outcome Measures

Name	Time	Method
Degrees of Gait Profile Score overall	Day 1	Analyze Degrees of Gait Profile Score overall

Secondary Outcome Measures

Name	Time	Method
Gait Profile Score right	Month 2	Analyze Gait Profile Score right.
Gait Profile Score left	Year 2	Analyze Gait Profile Score left.

Trial Locations

Locations (1)

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France