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

NCT07650370 | Not Yet Recruiting

• 1 other identifier: 2026_01_RCMs_RIPH2
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cerebral Palsy; Gait rehabilitation; Knee-extension orthosis; Treadmill training; Single-case experimental design

Outcome Measures

Primary Outcomes (1)

• Hip and Lumbopelvic 3D Kinematics during CMC-assisted Walking

  Three-dimensional kinematic curves of the hip and lumbopelvic complex recorded by motion capture (Qualisys optoelectronic system, IOR Full Body Gait Model) during walking with and without CMCs, on ground and on treadmill (DIG). Mean joint angles are extracted at key gait cycle events (initial contact, loading response \~10%, mid-stance, terminal stance, peak swing \~70%).

  Assessed at each of the 4 weekly measurement sessions during Phase B (weeks 5, 6, 7, and 8 from study start).

Secondary Outcomes (13)

• Surface EMG Muscle Activation Timing

  Assessed at each of the 4 weekly measurement sessions during Phase B (weeks 5-8).

• Walking Speed

  Assessed at all 10 measurement time points: 3 baseline sessions (Phase A, weeks 1-4), 4 intervention sessions (Phase B, weeks 5-8), and 3 follow-up sessions (1, 3, and 6 months post-intervention).

• Pain Perception during CMC Training

  Recorded after each of the 16 training sessions during Phase B (weeks 5-8).

• Hip Extensor and Flexor Muscle Strength

  Assessed at all 10 measurement time points across Phase A (weeks 1-4), Phase B (weeks 5-8), and Phase FU (1, 3, and 6 months post-intervention).

• Gait Quality - 3D Kinematic and Kinetic Curves without CMCs

  Assessed at all 10 measurement time points across Phase A (weeks 1-4), Phase B (weeks 5-8), and Phase FU (1, 3, and 6 months post-intervention).

Study Arms (1)

Assisted Treadmill Walking Training

EXPERIMENTAL

Children with bilateral spastic cerebral palsy undergo a 4-week treadmill walking program wearing cruro-malleolar casts (CMCs) - rigid bivalved knee-extension orthoses molded over their existing ankle-foot orthoses. Training consists of 16 sessions (4/week) of 20-minute treadmill walking with physiotherapist guidance and self-selected music. At 4 weekly assessment time points, participants are evaluated in 4 randomized conditions: ground walking with AFO alone, ground walking with AFO + CMCs, instrumented treadmill with AFO alone, and treadmill with AFO + CMCs, using 3D motion capture, surface EMG, and force platforms. Pain (Faces VAS) and perceived exertion (modified Borg scale) are recorded after each session. This phase is preceded by a 1-month baseline (3 sessions) and followed by a 6-month follow-up (at 1, 3, and 6 months).

Device: Cruro-Malleolar Cast Walking Training

Interventions

Cruro-Malleolar Cast Walking Training DEVICE

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.

Assisted Treadmill Walking Training

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Julie Rozaire, PhD

CONTACT

+334 72 38 11 43; lab.massues@croix-rouge.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share