Clinical trial NCT02944929: 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
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Spastic Hemiparesis
Keywords: Spastic hemiparesis
Stroke
Self-rehabilitation
Botulinum Toxin Injections
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Goal Attainment Scaling (GAS).
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of the Functional Independence Measure (FIM)
timeFrame: 6 months
measure: Assessment of Hemispatial neglect
timeFrame: 6 months
measure: Quality of life questionnaire
timeFrame: 6 months
measure: Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment)
timeFrame: 6 months
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas Roche, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonnyaud C, Gallien P, Decavel P, Marque P, Aymard C, Pellas F, Isner ME, Boyer FC, Muller F, Daviet JC, Dehail P, Perrouin-Verbe B, Bayle N, Coudeyre E, Perennou D, Laffont I, Ropers J, Domingo-Saidji NY, Bensmail D, Roche N; ADJU-TOX Study Group. Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, investigator blinded study. BMJ Open. 2018 Aug 30;8(8):e020915. doi: 10.1136/bmjopen-2017-020915.