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New treatment option for Cerebral Palsy
Official title Gait Training Program With Blood Flow Restriction in Children With Cerebral Palsy - EMBRIN: Pilot Study
ClinicalTrials.gov ID: NCT06533956
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18
You may be able to join if
- 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
You likely can't join if
- 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;
See the full eligibility 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;
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.