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"

Not yet recruiting

Phase 4 Results N/A

Trial Description

The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections 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

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 ( Botulinum Toxin Injections).
Botulinum Toxin Injections 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 Botulinum Toxin Injections could significantly improve activity limitation.
The addition of a self-rehabilitation program to Botulinum Toxin Injections and usual out-patient physiotherapy could thus increase the effects of Botulinum Toxin Injections on impairment and activity limitation in patients with spastic hemiparesis following stroke.

Conditions

Interventions

  • Self-rehabilitation program Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Self-rehabilitation program
    Description: Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy)

Outcomes

Type Measure Time Frame Safety Issue
Primary Assessment of Goal Attainment Scaling (GAS). 6 months
Secondary Assessment of the Functional Independence Measure (FIM) 6 months
Secondary Assessment of Hemispatial neglect 6 months
Secondary Quality of life questionnaire 6 months
Secondary Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment) 6 months

Sponsors