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

Study acronym: EMBRIN
StatusRecruiting
PhaseNot applicable
Started2024-10-31
View on ClinicalTrials.gov ↗

Amendment history

2026-06-12
minor
Study Identification, Study Status, Oversight, Study Design, IPDSharing v2
Primary completion dateestimated 2026-10-31→confirmed 2025-08-12
Completion date2027-06-30→2026-10-01
Enrollment target10→13
Study titlerevised
Gait Training Program withWith Blood Flow Restriction in Children withWith Cerebral Palsy - EMBRIN: Pilot Study
2024-11-06
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-09→2026-10-31
Completion date2027-05→2027-06-30
Start dateestimated 2024-09→confirmed 2024-10-31
Study sitesdetails revised at 2 of 2 sites
Study titlerevised
Gait Training Program Withwith Blood Flow Restriction in Children Withwith Cerebral Palsy - EMBRIN: Pilot Study
2024-07-31
minor
Original filing
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. 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.
Trial Details
NCT Number NCT06533956
Lead Sponsor University Hospital, Angers
Conditions Cerebral Palsy
Enrollment 13 participants
Start Date 2024-10-31
Primary Completion 2025-08-12 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-16