Status:
RECRUITING
Gait Training Program with Blood Flow Restriction in Children with Cerebral Palsy - EMBRIN: Pilot Study
Lead Sponsor:
University Hospital, Angers
Conditions:
Cerebral Palsy
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
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 (BF...
Detailed Description
Context : Cerebral palsy (CP) is the leading cause of motor disability in children, with a prevalence of 1.77 cases per 1000 births. It is defined as a set of permanent developmental disorders of mov...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06533956
Start Date
October 31 2024
End Date
June 30 2027
Last Update
November 8 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Les Capucins
Angers, France
2
University Hospital, Angers
Angers, France