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OpenTrials
Completed

NCT Number: NCT06505499

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Saint Etienne

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gait Profile Score

Other

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

Gait Visual Score

Other

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

Primary outcomes

  1. Degrees of Gait Profile Score overall

    Time frame: Day 1

    Analyze Degrees of Gait Profile Score overall

Secondary outcomes

  1. Gait Profile Score right

    Time frame: Month 2

    Analyze Gait Profile Score right.

  2. Gait Profile Score left

    Time frame: Year 2

    Analyze Gait Profile Score left.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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