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 (ADJU-TOX)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Garches, France, 92380
- Recruiting
- Hôpital Raymond Poincaré
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Self-rehabilitation program
Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy)
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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.
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NO_INTERVENTION: Control arm
Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Goal Attainment Scaling (GAS).
Time Frame: 6 months
|
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 |
Time Frame |
|---|---|
|
Quality of life questionnaire
Time Frame: 6 months
|
6 months
|
|
Assessment of the Functional Independence Measure (FIM)
Time Frame: 6 months
|
6 months
|
|
Assessment of Hemispatial neglect
Time Frame: 6 months
|
6 months
|
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Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P150907
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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