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

NCT06505499 | Completed

• 1 other identifier: IRBN402024/CHUSTE
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Gait Disorders in Children

Keywords

Cerebral palsy; Gait profile score; Botulinum toxin injection; Multilevel surgery

Outcome Measures

Primary Outcomes (1)

• Degrees of Gait Profile Score overall

  Analyze Degrees of Gait Profile Score overall

  Day 1

Secondary Outcomes (2)

• Gait Profile Score right

  Month 2

• Gait Profile Score left

  Year 2

Study Arms (1)

EXPERIMENTAL GROUP

Children and teenagers with CP with an instrumented gait analysis performed since 2019.

Other: Gait Profile Score; Other: Gait Visual Score

Interventions

Gait Profile Score OTHER

Gait Profile Score in degrees, calculated from kinematic raw data with the Gdi\_GPS\_calculator spreadsheet developed by Baker (2009).

EXPERIMENTAL GROUP

Gait Visual Score OTHER

Gait Visual Score in degrees, calculated from kinematic raw data with the Gdi\_GPS\_calculator spreadsheet developed by Baker (2009)

EXPERIMENTAL GROUP

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

Children and adolescents with cerebral palsy treated at the Saint-Etienne University Hospital will be included.

You may qualify if:

• Etiology of cerebral palsy
• Unilateral, bilateral, triplegic or quadriplegic forms of cerebral palsy.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu de Saint Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Clément BOULARD, physiotherapist

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: March 6, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)