Pilot Study on the Validity, Tolerability, and Impact of a Walking Rehabilitation Intervention Us… (NCT07650370) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Study on the Validity, Tolerability, and Impact of a Walking Rehabilitation Intervention Using Cruro-Malleolar Cast in Children With Cerebral Palsy
6 participantsStarted 2026-09-01
Plain-language summary
This pilot study investigates whether walking training using cruro-malleolar casts (CMCs) - rigid leg splints extending from the thigh to the ankle - can safely improve gait quality in children with bilateral cerebral palsy (CP). CMCs are already used in routine clinical care at our center, but their biomechanical effects and therapeutic value have never been formally studied.Children aged 7 to 14 with bilateral spastic CP (diplegia or quadriplegia, GMFCS levels I-III) will participate in a 4-week treadmill walking program wearing CMCs, preceded by a 1-month observation baseline and followed by a 6-month follow-up. The investigators will use motion capture technology and surface electromyography to measure how the CMCs immediately change the way children walk - particularly at the hip and pelvis - and whether the training program leads to lasting improvements in walking speed, quality, and endurance.The study also carefully monitors pain and effort perceived by children during each training session, so that tolerance of the intervention can be rigorously assessed. Six participants will be enrolled. The study uses a Single-Case Experimental Design (SCED), which allows rigorous conclusions to be drawn from a small number of patients through repeated measurements over time.
Who can participate
Age range
7 Years – 14 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
* Children aged 7 to 14 years
* Pubertal development at Tanner stage 1 or 2
* Bilateral cerebral palsy (diplegia or quadriplegia)
* Ambulatory with or without assistive device (GMFCS levels I, II, or III)
* Clinical indication for walking training
* Ability to use an adapted visual analogue scale to rate perceived pain
* No botulinum toxin injection in the 4 months preceding study entry
* Affiliated to or beneficiary of a French social security scheme
* Not currently enrolled in another biomedical research study (not in an exclusion period from the national registry)
EXCLUSION CRITERIA
* Pubertal development at Tanner stage greater than 2
* Refusal to wear cruro-malleolar casts (CMCs)
* Inability to walk on a treadmill
* Refusal to participate in the repeated assessment sessions required by the study protocol
* Refusal to delay the next scheduled botulinum toxin injection series until after completion of study participation
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.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for us to wait for it or pursue other options in the meantime?
2Since this is described as a pilot study, what does that mean for what's already known about the safety and effectiveness of using a cruro-malleolar cast for walking rehabilitation in children with cerebral palsy?
3The trial is specifically measuring 3D movement of the hips and pelvis during walking with the cast — based on my child's particular movement patterns and type of cerebral palsy, do you think those are the right outcomes to be tracking for their situation?
4What would wearing a cruro-malleolar cast actually involve day-to-day for my child, and are there realistic concerns about comfort, skin integrity, or how they'd tolerate it during the study?
5Are there standard physical therapy or orthotic approaches we should consider first before a pilot study like this, given that the evidence base for this specific intervention is still being established?
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
Hip and Lumbopelvic 3D Kinematics during CMC-assisted Walking
Timeframe: Assessed at each of the 4 weekly measurement sessions during Phase B (weeks 5, 6, 7, and 8 from study start).
Trial details
NCT IDNCT07650370
SponsorCentre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française