Gait Profile Score in Children With Cerebral Palsy (CP): Influence of the CP Type, Treatment With… (NCT06505499) | Clinical Trial Compass
CompletedNot Applicable
Gait Profile Score in Children With Cerebral Palsy (CP): Influence of the CP Type, Treatment With Botulinum Injection and Multilevel Surgery
France51 participantsStarted 2024-03-06
Plain-language 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.
Who can participate
Age range
6 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Degrees of Gait Profile Score overall
Timeframe: Day 1
Trial details
NCT IDNCT06505499
SponsorCentre Hospitalier Universitaire de Saint Etienne