Pilot Study on the Validity, Tolerability, and Impact of a Walking Rehabilitation Intervention Using Cruro-Malleolar Cast in Children With Cerebral Palsy

Starting soon · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT07650370

Run by

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

People needed

6

Starts

2026-09-01

Expected to finish

2028-09-01

Last updated by the study team

2026-06-22

Who can join

Age: 7 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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