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

NCT06533956 | Recruiting

• 1 other identifier: 49RC23_0258
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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 (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

Cerebral Palsy

Keywords

Cerebral palsy; Blood Flow Restriction; Walking training; Pediatric rehabilitation

Outcome Measures

Primary Outcomes (1)

• Comparison of changes in walking speed with standard rehabilitation and with gait training associated with BFR.

  The evaluation criterion is the change in walking speed between D-70-J0 and D0-J+70.

  Patients' walking speed will be compared between Day -70 to Day 0 (standard rehabilitation) and Day 0 to Day +70 (gait training program + BFR)

Study Arms (1)

gait training associated with BFR

EXPERIMENTAL

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.

Other: 10-week gait training program combined with simultaneous blood flow restriction (BFR).

Interventions

10-week gait training program combined with simultaneous blood flow restriction (BFR). OTHER

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.

gait training associated with BFR

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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
• 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;

You may not qualify 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;
• Persons under compulsory psychiatric care;
• Persons under legal protection

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

Les Capucins

Angers, France

RECRUITING

University Hospital, Angers

Angers, France

NOT YET RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Adélie Christiaens

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adélie Christiaens

CONTACT

2 41 35 18 04; adelie.christiaens@univ-angers.fr

Anthéa LOIEZ

CONTACT

2 41 35 43 82; anthea.loiez@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 1, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)