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Gait Training Program With Blood Flow Restriction in Children With Cerebral Palsy - EMBRIN: Pilot Study

Key facts

Who runs it
University Hospital, Angers
Where
France2 sites in 1 countryChoose a country to see its 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?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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.

Read full original descriptionShow less

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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