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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
124
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.
Henri Mondor Hospital
Créteil, France
Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs)
1. Fast 10-meter barefoot ambulation speed with no assistive device 2. Active upper limb function using the Modified FRENCHAY scale (10 everyday life activities performed live in front of the investigator and videotaped - videos reviewed later by a blinded investigator).
Time frame: After one year of treatment
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)
European Quality of Life Scale
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
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