Actively Recruiting

Phase Not Applicable
Age: 8Years - 18Years
All Genders
NCT06533956

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

Led by University Hospital, Angers · Updated on 2024-11-08

10

Participants Needed

2

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 8 to 18 with bilateral spastic cerebral palsy
  • Functional level II or III according to the Gross Motor Function Classification System (GMFCS)
  • Able to assess pain with NRS-11
  • Able to walk on a treadmill without body weight support, with or without technical aids
  • Able to perform the 10-meter walk test
  • No skin problems at the cuff application site
  • Affiliated with or benefiting from a social security scheme
  • Informed consent signed by patient or guardian
Not Eligible

You will not qualify if you...

  • Surgical treatment or botulinum toxin injections in lower limbs within last 3 months
  • History of arterial hypertension, thrombo-embolic events, thrombophilia, or cancer
  • Insufficient understanding of French
  • Opposition to participation by patient
  • Pregnant, breast-feeding, or recently given birth
  • Deprived of liberty by judicial or administrative decision
  • Under compulsory psychiatric care
  • Under legal protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Les Capucins

Angers, France

Actively Recruiting

2

University Hospital, Angers

Angers, France

Not Yet Recruiting

Loading map...

Research Team

A

Adélie Christiaens

CONTACT

A

Anthéa LOIEZ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Gait Training Program with Blood Flow Restriction in Children with Cerebral Palsy - EMBRIN: Pilot Study | DecenTrialz