Gait training with blood flow restriction for children with cerebral palsy
Programme D'Entrainement À La Marche Avec Blood Flow RestrIctioN Chez L'enfant Avec Paralysie Cérébrale - EMBRIN: Etude Pilote
This study is trying out a new walking training program with blood flow restriction to see if it helps children with cerebral palsy walk faster and better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 2 sites (Angers and 1 other locations) |
| Trial ID | NCT06533956 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility and effects of a 10-week gait training program combined with blood flow restriction (BFR) on walking speed in children aged 8 to 18 with bilateral spastic cerebral palsy. Participants will engage in treadmill sessions three times a week, gradually increasing their walking speed while under BFR conditions. The study aims to assess both the tolerability of the intervention and its impact on improving walking efficiency and endurance in this population. The program includes a week of habituation without BFR followed by nine weeks of training with BFR.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 18 with bilateral spastic cerebral palsy who can walk on a treadmill without support.
Not a fit: Patients with recent surgical treatments or those with certain medical histories, such as arterial hypertension or cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance walking speed and overall mobility in children with cerebral palsy.
How similar studies have performed: While gait training and muscle strengthening have been studied separately, few programs have combined these approaches, making this a novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 8 to 18 with bilateral spastic cerebral palsy * Patient with functional level II or III according to the Gross Motor Function Classification System (GMFCS) * Patient able to assess pain with NRS-11 * Patient able to walk on a treadmill without body weight support, with or without technical aids * Patient able to perform the 10-meter walk test * No skin pathology at the pressure cuff application site (eczema, inflammatory scarring, etc.) * Patient affiliated to or benefiting from a social security scheme * Informed consent, dated and signed by parents or guardians (if a minor) or by the patient (if of age), to participate in the study; Exclusion Criteria: * Patients who have undergone surgical treatment or intramuscular injections of botulinum toxin in the lower limbs within the last 3 months * Patients with a history of arterial hypertension, thrombo-embolic events, thrombophilia or cancer. * Patient with insufficient understanding of the French language; * Opposition of the patient (child or adolescent); * Pregnant, breast-feeding or parturient women; * Persons deprived of their liberty by judicial or administrative decision; * Persons under compulsory psychiatric care; * Persons under legal protection
Where this trial is running
Angers and 1 other locations
- Les Capucins — Angers, France (Recruiting)
- University Hospital, Angers — Angers, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Adélie Christiaens — University Hospital, Angers
- Study coordinator: Adélie Christiaens
- Email: adelie.christiaens@univ-angers.fr
- Phone: 2 41 35 18 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.