Pilot Study on the Validity, Tolerability, and Impact of a Walking Rehabilitation Intervention Using Cruro-Malleolar Cast in Children With Cerebral Palsy (RCMs)
16 giugno 2026 aggiornato da: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Phase FU (Follow-up, 6 months): Three measurement sessions at 1, 3, and 6 months post-intervention.
The per-patient protocol lasts 8 months. Inclusion will span 30 months, for a total study duration of 3 years, starting from CPP approval.
Tipo di studio
Interventistico
Iscrizione (Stimato)
6
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Julie Rozaire, PhD
- Numero di telefono: +334 72 38 11 43
- Email: lab.massues@croix-rouge.fr
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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).
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hip and Lumbopelvic 3D Kinematics during CMC-assisted Walking
Lasso di tempo: Assessed at each of the 4 weekly measurement sessions during Phase B (weeks 5, 6, 7, and 8 from study start).
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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%).
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Assessed at each of the 4 weekly measurement sessions during Phase B (weeks 5, 6, 7, and 8 from study start).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Surface EMG Muscle Activation Timing
Lasso di tempo: Assessed at each of the 4 weekly measurement sessions during Phase B (weeks 5-8).
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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.
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Assessed at each of the 4 weekly measurement sessions during Phase B (weeks 5-8).
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Walking Speed
Lasso di tempo: 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).
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Walking speed is defined as the velocity at which an individual walks, recorded with and without CMCs, on ground and on treadmill.
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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).
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Pain Perception during CMC Training
Lasso di tempo: Recorded after each of the 16 training sessions during Phase B (weeks 5-8).
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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.
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Recorded after each of the 16 training sessions during Phase B (weeks 5-8).
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Hip Extensor and Flexor Muscle Strength
Lasso di tempo: 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).
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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.
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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).
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Gait Quality - 3D Kinematic and Kinetic Curves without CMCs
Lasso di tempo: 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).
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Full lower limb 3D kinematic curves and joint moments/powers (hip, knee, ankle) recorded without CMCs, on ground and on treadmill., used to assess changes in overall gait pattern over time including sagittal plane locomotor profile, anterior knee vector positioning, and trunk/pelvic alignment.
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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).
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Walking Endurance - 6-Minute Walk Test (6MWT)
Lasso di tempo: 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).
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Distance covered in 6 minutes (meters) on a 30-meter indoor corridor with standardized instructions and encouragements, performed with the participant's habitual walking aids and orthoses.
A validated functional walking capacity test widely used in pediatric cerebral palsy populations.
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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).
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Cadence
Lasso di tempo: 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)
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Cadence is a measure of speed calculated as the total number of full cycles (of both a right and left foot strike) taken within a given period of time, often expressed in steps per minute or cycles per minute recorded with and without CMCs, on ground and on treadmill.
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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)
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Step Length
Lasso di tempo: 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)
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Step length is the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot.
Recorded with and without CMCs, on ground and on treadmill.
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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)
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Stride Length
Lasso di tempo: 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)
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Stride length is defined as the distance between two points where the same foot strikes the ground sequentially, encompassing the sum of left and right step lengths.
Recorded with and without CMCs, on ground and on treadmill.
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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)
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Step Width
Lasso di tempo: 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)
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The mediolateral space between the two feet (the difference between right and left heels during gait).
Recorded with and without CMCs, on ground and on treadmill.
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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)
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Single Support Duration
Lasso di tempo: 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)
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The period of time when only one foot is in contact with the ground recoreded with and without CMCs, on ground and on treadmill.
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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)
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Double Support Time
Lasso di tempo: 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)
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The period of time when both feet are in contact with the ground recorded with and without CMCs, on ground and on treadmill.
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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)
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Stance ratio
Lasso di tempo: 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)
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The ratio between the entire gait cycle and stance phase recoreded with and without CMCs, on ground and on treadmill.
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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)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 settembre 2028
Completamento dello studio (Stimato)
1 settembre 2028
Date di iscrizione allo studio
Primo inviato
21 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
10 giugno 2026
Primo Inserito (Effettivo)
16 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026_01_RCMs_RIPH
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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