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

January 9, 2025 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

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

  • France
      • Saint Etienne, France, 42000
        • CHU de Saint Etienne

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 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
Intervention / Treatment
EXPERIMENTAL GROUP
Children and teenagers with CP with an instrumented gait analysis performed since 2019.
Other: Gait Profile Score
Gait Profile Score in degrees, calculated from kinematic raw data with the Gdi_GPS_calculator spreadsheet developed by Baker (2009).
Other: Gait Visual Score
Gait Visual Score in degrees, calculated from kinematic raw data with the Gdi_GPS_calculator spreadsheet developed by Baker (2009)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degrees of Gait Profile Score overall
Time Frame: Day 1
Analyze Degrees of Gait Profile Score overall
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Profile Score right
Time Frame: Month 2
Analyze Gait Profile Score right.
Month 2
Gait Profile Score left
Time Frame: Year 2
Analyze Gait Profile Score left.
Year 2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Profile Score overall
Time Frame: Month 2
Gait Profile Score in degrees, calculated from kinematic raw data with the Gdi_GPS_calculator spreadsheet developed by Baker (2009).
Month 2
Gait Profile Score overall
Time Frame: Year 2
Gait Profile Score in degrees, calculated from kinematic raw data with the Gdi_GPS_calculator spreadsheet developed by Baker (2009).
Year 2

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Clément BOULARD, physiotherapist, CHU de Saint-Etienne

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)

March 6, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN402024/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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