Gait Training Program With Blood Flow Restriction in Children With Cerebral Palsy - EMBRIN: Pilot Study
Key facts
- Who runs it
- University Hospital, Angers
- Where
- Angers, FranceSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 13 people, planned
- Started
- 31 Oct 2024
- Planned end
- 1 Oct 2026
- Type of study
- Interventional
- Treatments tested
- 10-week gait training program combined with simultaneous blood flow restriction (BFR).
- Record updated
- 16 June 2026
Who can take part
- Age
- 8 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
- Persons under compulsory psychiatric care
- 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 legal protection
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 18 years old?
Where in France
- Les CapucinsAngers, FranceContact: Adélie ChristiaensTaking people
- University Hospital AngersAngers, FranceContact: Adélie ChristiaensNot yet recruiting
About the trial
What the trial wants to find out
This is a single-center prospective experimental pilot study to assess the feasibility, tolerability and effect of a 10-week gait training program combined with simultaneous blood flow restriction (BFR) on the walking speed of children, aged 8 to 18, with bilateral spastic cerebral palsy.
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The children will receive a 10-week intervention (1 week of habituation without BFR + 9 weeks with BFR) comprising 3 30-minute treadmill sessions per week. At each session, the first 5 minutes will enable a gradual increase in speed, and then the maximum tolerated walking speed will be sought. Maximum speed corresponds to the walking speed maintained by the child for an effort of between 5 and 7 on Borg's 10-point VAS. The rehabilitator will encourage the child to maintain this speed and provide feedback on performance. The BFR setting will maintain an occlusion, at the root level of both lower limbs, of 60% of the total occlusal pressure.
Children receiving the 10-week EMBRIN program are expected to improve their walking ability and muscular strength, two targets recognized as priorities for individuals with CP by the HAS. In this population, a major limitation of implementing rehabilitation programs is the large amount of practice required to bring about significant changes. This large amount of practice requires a major investment on the part of the individual, as well as significant rehabilitation resources. Muscle-strengthening programs are also particularly repetitive and therefore not very motivating for children. The EMBRIN program could reduce the training load and duration required to impact functional performance in children with CP. It could also help reduce the cost of rehabilitation interventions and reduce physical therapy time for individuals with CP in favor of their social participation.
The group in the trial
- gait training associated with BFRTreatment being tested
The children will receive a 10-week intervention (1 week of habituation without BFR + 9 weeks with BFR) comprising 3 30-minute treadmill sessions per week. At each session, the first 5 minutes will enable a gradual increase in speed, and then the maximum tolerated walking speed will be sought. Maximum speed corresponds to the walking speed maintained by the child for an effort of between 5 and 7 on Borg's 10-point VAS. The rehabilitator will encourage the child to maintain this speed and provide feedback on performance. The BFR setting will maintain an occlusion, at the root level of both lower limbs, of 60% of the total occlusal pressure.
Treatment: 10-week gait training program combined with simultaneous blood flow restriction (BFR).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Programme d'Entrainement à la Marche Avec Blood Flow RestrIctioN Chez l'Enfant Avec Paralysie cérébrale - EMBRIN: Etude Pilote
- Fit questions
- Built from NCT06533956, who can take part
- Publications
- Record updated
- 16 June 2026