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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-14
SponsorCentre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Assisted Treadmill Walking TrainingExperimental treatment 1 intervention

Trial outcomes

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%).

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

Secondary outcomes

1

Surface EMG Muscle Activation Timing

Activation timing (onset and offset, expressed as % of gait cycle) of hamstrings (semitendinosus), rectus femoris, vastus lateralis, and gluteus maximus, recorded by surface EMG (Cometa Pico) during walking with and without CMCs, on ground and on treadmill.

Time frame
Assessed at each of the 4 weekly measurement sessions during Phase B (weeks 5-8).
2

Walking Speed

Walking speed is defined as the velocity at which an individual walks, recorded with and without CMCs, on ground and on treadmill.

Time frame
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).
3

Pain Perception during CMC Training

Child-reported pain perception related to CMC wearing, measured by the Faces Visual Analogue Scale (0-10, 0 = no pain, 10 = unbearable pain) after each training session.

Time frame
Recorded after each of the 16 training sessions during Phase B (weeks 5-8).
4

Hip Extensor and Flexor Muscle Strength

Isometric strength of hip extensor and flexor muscles measured by dynamometry, and active hip extension range of motion, assessed in prone position at the edge of the table.

Time frame
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).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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