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

NCT07650370 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-06-22

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

DEVICE

Cruro-Malleolar Cast Walking Training

Cruro-malleolar casts (CMCs) are rigid bivalved knee-extension orthoses molded over the child's existing functional ankle-foot orthosis. Fabricated by a nurse-plaster technician and physiotherapist, they include protective padding, corrective felt inserts promoting knee extension, and supra-condylar fixation hooks. Windows are cut in the CMCs to allow surface EMG electrode and reflective marker placement during gait analysis. CMCs are worn during treadmill walking training (16 sessions over 4 weeks, 4 sessions/week, 20 minutes/session) on an instrumented treadmill (DIG system) with physiotherapist guidance. They are also worn during ground and treadmill gait analysis sessions. CMC walking is compared to walking with ankle-foot orthoses alone, both on ground and on the instrumented treadmill, within each participant across repeated assessment sessions.

Sponsors & Collaborators

  • Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-30
Completion
2028-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07650370 on ClinicalTrials.gov