ADJU-TOX: 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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT02944929

Collaborator

(none)

220

Enrollment

Location

Arms

36.1

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spastic Hemiparesis	Other: Self-rehabilitation program	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Jan 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-rehabilitation program Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy)	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.
No Intervention: Control arm Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program

Arm

Intervention/Treatment

Experimental: Self-rehabilitation program

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

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.

No Intervention: Control arm

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

Outcome Measures

Primary Outcome Measures

Assessment of Goal Attainment Scaling (GAS). [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.

Secondary Outcome Measures

Assessment of the Functional Independence Measure (FIM) [6 months]
Assessment of Hemispatial neglect [6 months]
Quality of life questionnaire [6 months]
Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.