Overview

This trial is active, not recruiting.

Condition hemiparesis
Treatment guided self-rehabilitation contract
Sponsor Assistance Publique - Hôpitaux de Paris
Start date March 2014
End date December 2016
Trial size 124 participants
Trial identifier NCT02202954, 2012-A00348-35, P100114

Summary

In the situation of motor limitations that people often experience after stroke, current health systems cannot provide for the daily amount and duration of high intensity muscle stretch and motor training that would be required over protracted periods to involve muscle and brain plasticity. For patients with sufficient cognitive abilities, Guided Self-rehabilitation Contracts allow implementing stretch and training at high intensity and may result in meaningful functional improvement in chronic stages, as long as discipline persists over at least a year span.

This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as against conventional therapy in the community, for a one year duration in persons with chronic hemiparesis after stroke.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract. The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary.
guided self-rehabilitation contract
In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract. The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary.
(No Intervention)
conventional therapy in the community

Primary Outcomes

Measure
Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs)
time frame: After one year of treatment

Secondary Outcomes

Measure
Speed, step length and cadence over 10 meters at comfortable speed, barefoot and with shoes, with no assistive device
time frame: One assessment visit every 6 month for 2 years
Speed, step length, cadence and physiological cost index over 2 minutes at maximal speed, with shoes
time frame: One assessment visit every 6 month for 2 years
Disability Assessment Scale: interview between patient and investigator, assessing the level of disability in 4 domains (dressing, cosmesis, hygiene and pain)
time frame: One assessment visit every 6 month for 2 years
Barthel Activity of Daily Living (ADL) Index
time frame: One assessment visit every 6 month for 2 years
Euro-Qol - 5 dimension (EQ-5D)
time frame: One assessment visit every 6 month for 2 years
Geriatric Depression Scale - 15
time frame: One assessment visit every 6 month for 2 years
Questionnaire to the patient (or caregiver) evaluating monthly frequency of physical therapy sessions and amount of home aid during the whole study period, that will serve as basis for a cost evaluation from the point of view of medical insurance.
time frame: One assessment visit every 6 month for 2 years
Estimation of the total cost of care, including medical costs, social expenses, amount of social benefits, from the point of view of the medical insurance and of the state, to include all payors.
time frame: One assessment visit every 6 month for 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient with spastic hemiparesis, following a unique stroke episode over a year before enrollment into the study - Age ≥ 18 - Barefoot walking possible with no assistive device over 10 m - Fast barefoot ambulation speed between 0.1 m/sec and 1.3 m/sec - Mean Modified FRENCHAY Score between 2 and 8/10 - Patient having provided a signed consent to participate in this trial Exclusion Criteria: - Multiple stroke episodes, clinically of based on brain imaging - No recent (less than 3 months before enrollment) brain imaging (CT scan or MRI) in case of doubt about multiple stroke episodes - Concurrent severe condition jeopardizing functional or vital prognosis, or the ability to participate in rehabilitation sessions - Cognitive, phasic or behavioral condition impeding verbal communication, active participation to a rehabilitation or self-rehabilitation program, or participation in a research study, according to the investigator's judgment - Person having a tutor or benefiting from a law protection order - Person not benefiting from French State Health Insurance

Additional Information

Official title Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke. Efficacy and Cost After One Year Treatment. A Randomized, Controlled, Multicenter, Single Blind Study
Principal investigator Jean-Michel GRACIES, MD, PhD
Description This single blind controlled multicentre protocol will compare the evolution after a one-year treatment, either using a Guided Self-rehabilitation Contract or conventional therapy in the community. Patients with chronic stroke-induced hemiparesis (over a year post stroke) will be selected to be randomized between the two groups, Conventional or in Guided Self-rehabilitation Contracts. In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: - Technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month. - Psychological, binding with the patient on the contract. The patient agrees to: - Perform the prescribed daily stretch postures and rapid alternating movements over the long term. - Document this work in a written diary. To facilitate such contracts, a manual for guided self-rehabilitation in spastic paresis has been developed and will be provided to patients randomized to that group. 124 patients will be enrolled from 6 centers in France: Creteil, Paris Fernand-Widal, Toulouse, Reims, Saint-Etienne and Bordeaux. The duration of patient participation will be 2 years: 6 months follow-up, 1 year intervention and another 6-month follow-up after the study intervention. Only functional assessments will be used, using in particular ambulation speed for the lower limb and the Modified FRENCHAY Scale for the upper limb.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.