The Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke

Study Overview
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Brief Summary
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The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI) and usual physiotherapy should increase the proportion of patients who attain their Primary Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum Toxin Injections and conventional physiotherapy), in post stroke out-patients with spasticity.

Detailed Description
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Stroke affects 150 000 persons in France each year. Most patients have activity limitations because of the resulting motor deficit and spasticity. Autonomy in activities of daily living is reduced. The principal treatment for focal spasticity is currently intramuscular botulinum toxin injection (BTI). BTI is classically combined with only 2 to 3 sessions of out-patient physiotherapy per week. This is mainly because of a lack of out-patient therapists. However, this amount of therapy is insufficient and does not follow current literature which shows that the intensity of physiotherapy affects the recovery of impairment and activity. This gap in our health system could be filled by a self-rehabilitation program in addition to physiotherapy. Recent studies have shown that self-rehabilitation following BTI could significantly improve activity limitation (Roche et al, 2014 ; Sun et al 2010). The addition of a self-rehabilitation program to BTI and usual out-patient physiotherapy could thus increase the effects of BTI on impairment and activity limitation in patients with spastic hemiparesis following stroke.

Official Title
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Randomised Controlled Trial to Evaluate the Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity (Repeated Botulinum Toxin Injections and Physiotherapy) on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke

Conditions
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Spastic Hemiparesis

Intervention / Treatment
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* Other: Self-rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged between 18 to 75 years. Adult patient under guardianship with consent obtained and the legal guardian's authorisation obtained. Single stroke having occurred more than 6 months before (previous TIA is accepted). Capable of understanding instructions and participating in the definition of a therapeutic goal (Boston Diagnostic Aphasia Examination (BDAE) < 3). Having previously undergone BTI. The last injection must have been performed at least 4 months prior to inclusion. Affiliation to the French social security regime or a similar regime. Patient (or the legal guardian if under guardian adult patient) has signed the informed consent form. Exclusion Criteria: Patients who are unwilling to participate in the study. For the one under guardianship, the refusal of the patient will be the final decision even if the guardian is willing to participate. Subjects who are unlikely to adhere to the study an/or poor adherence anticipated by the investigator. Un-controlled progressive pathology. Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study. Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.). Surgery to the treated limb less than 6 months previously. Pregnant woman.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-rehabilitation program<br>Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy) | Other: Self-rehabilitation program<br>* The self-rehabilitation program will be based on muscle stretching, strengthening and task oriented exercises. For each patient, two exercises will be selected by the therapist for each of these 3 domains (total of 6 exercises) from a list of 50 exercises.<br>|
| No Intervention: Control arm<br>Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Goal Attainment Scaling (GAS). | The percentage of patients who attain their Primary Treatment Goal determined using Goal Attainment Scaling (GAS) at each visits and in both groups. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Functional Independence Measure (FIM) |  | 6 months | 
| Assessment of Hemispatial neglect |  | 6 months | 
| Quality of life questionnaire |  | 6 months | 
| Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spastic hemiparesis, Stroke, Self-rehabilitation, Botulinum Toxin Injections