Pilot Study on the Validity, Tolerability, and Impact of a Walking Rehabilitation Intervention Using Cruro-Malleolar Cast in Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 6
- Primary Endpoint
- Hip and Lumbopelvic 3D Kinematics during CMC-assisted Walking
Study Overview
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.
Detailed Description
Background and rationale Cerebral palsy is the most common cause of motor disability in children. Among its clinical forms, spastic diplegia is characterized by predominant lower limb involvement and progressive gait deterioration during growth, driven by musculotendinous contractures and secondary orthopedic complications. From Rodda and Graham's gait classification Group II ("jump gait") onward, hamstring overactivity plays a central role - contributing to excessive knee flexion and limited hip extension in late stance. Interventions targeting active hamstring stretching in a controlled gait pattern may therefore have significant clinical value.
Cruro-malleolar casts (CMCs) are knee-extension orthoses molded over the child's walking ankle-foot orthosis. In current clinical practice at our center, they are used both for passive stretching postures and as a gait rehabilitation tool. The hypothesized mechanisms during CMC-assisted walking include: active hamstring stretch at initial contact; increased hip extensor (gluteus maximus) activation during loading response and mid-stance; improved pelvic belt mobility and trunk extension in the frontal plane; increased eccentric hip flexor activity and posterior step in late stance - effects that are expected to be amplified when training is performed on a treadmill. Despite their use in clinical practice, no published study has evaluated the biomechanical, muscular, or functional effects of CMCs during walking training.
Study design This study uses a nested Single-Case Experimental Design (SCED), combining an A-B-Follow-up series with an Alternating Treatments Design (ATD) embedded within Phase B.
Phase A (Baseline, 1 month): Three repeated measurement sessions (every 15 days), with no intervention. Establishes each participant's individual baseline trajectory.
Phase B (Intervention, 1 month): Four weekly measurement sessions. Participants perform 4 sessions per week of treadmill walking training with CMCs (20 minutes per session, with verbal and/or manual guidance from a physiotherapist, and music chosen by the child to support motivation). At each of the 4 measurement time points within Phase B, participants are assessed in 4 randomized conditions: walking on ground with ankle-foot orthoses (AFO) alone; walking on ground with AFO + CMCs; walking on the instrumented treadmill (DIG) with AFO alone; walking on DIG with AFO + CMCs. Randomization of condition order is restricted by practical and safety constraints (ground assessments must precede treadmill assessments; treadmill speed is capped at ground walking speed).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Assisted Treadmill Walking Training
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).
Intervention: Cruro-Malleolar Cast Walking Training (Device)
Outcomes
Primary Outcomes
Hip and Lumbopelvic 3D Kinematics during CMC-assisted Walking
Time Frame: Assessed at each of the 4 weekly measurement sessions during Phase B (weeks 5, 6, 7, and 8 from study start).
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%).
Secondary Outcomes
- 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).)
- Walking Endurance - 6-Minute Walk Test (6MWT)(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).)
- Cadence(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))
- Step Length(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))
- Stride Length(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))
- Step Width(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))
- Single Support Duration(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))
- Double Support Time(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))
- Stance ratio(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))