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
NCT02944929 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2020-03-27
Summary
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.
Conditions
- Spastic Hemiparesis
Interventions
- OTHER
-
Self-rehabilitation program
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.
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Nicolas Roche, MD · Assistance Publique - Hôpitaux de Paris
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-01
- Primary Completion
- 2020-12-31
- Completion
- 2021-01-03
Countries
- France
Study Locations
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