Clinical trial NCT02202954: Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiparesis
Keywords: Stroke
Muscle Spasticity
Rehabilitation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs)
timeFrame: 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
timeFrame: One assessment visit every 6 month for 2 years
measure: Speed, step length, cadence and physiological cost index over 2 minutes at maximal speed, with shoes
timeFrame: One assessment visit every 6 month for 2 years
measure: Disability Assessment Scale: interview between patient and investigator, assessing the level of disability in 4 domains (dressing, cosmesis, hygiene and pain)
timeFrame: One assessment visit every 6 month for 2 years
measure: Barthel Activity of Daily Living (ADL) Index
timeFrame: One assessment visit every 6 month for 2 years
measure: Euro-Qol - 5 dimension (EQ-5D)
timeFrame: One assessment visit every 6 month for 2 years
measure: Geriatric Depression Scale - 15
timeFrame: One assessment visit every 6 month for 2 years
measure: 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.
timeFrame: One assessment visit every 6 month for 2 years
measure: 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.
timeFrame: One assessment visit every 6 month for 2 years
Other outcomes:
measure: Evaluation by the occupational therapist of home adaptation and the functioning at home
timeFrame: One assessment visit every 6 month for 2 years
measure: Evaluation by a clinical psychologist of coping with each type of care (guided self-rehabilitation or conventional), of the required psychological resources and the potential need for psychological follow-up.
timeFrame: One assessment visit every 6 month for 2 years
Locations:
city: Créteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Michel GRACIES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gracies JM, Pradines M, Ghedira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.