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)

Assistance Publique - Hôpitaux de Paris

Status and phase: Unknown; Phase 3

Conditions: Spastic Hemiparesis

Treatments: Other: Self-rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT02944929

P150907

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females aged between 18 to 75 years.
2. Adult patient under guardianship with consent obtained and the legal guardian's authorisation obtained.
3. Single stroke having occurred more than 6 months before (previous TIA is accepted).
4. Capable of understanding instructions and participating in the definition of a therapeutic goal (Boston Diagnostic Aphasia Examination (BDAE) < 3).
5. Having previously undergone BTI. The last injection must have been performed at least 4 months prior to inclusion.
6. Affiliation to the French social security regime or a similar regime.
7. Patient (or the legal guardian if under guardian adult patient) has signed the informed consent form.

Exclusion criteria

1. 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.
2. Subjects who are unlikely to adhere to the study an/or poor adherence anticipated by the investigator.
3. Un-controlled progressive pathology.
4. Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study.
5. Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.).
6. Surgery to the treated limb less than 6 months previously.
7. Pregnant woman.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups

Self-rehabilitation program

Experimental group

Description:

Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy)

Treatment:

Other: Self-rehabilitation program

Control arm

No Intervention group

Description:

Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program