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)
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|ClinicalTrials.gov Identifier: NCT02944929|
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spastic Hemiparesis||Other: Self-rehabilitation program||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|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 :||November 20, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
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
- Assessment of Goal Attainment Scaling (GAS). [ Time Frame: 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.
- Assessment of the Functional Independence Measure (FIM) [ Time Frame: 6 months ]
- Assessment of Hemispatial neglect [ Time Frame: 6 months ]
- Quality of life questionnaire [ Time Frame: 6 months ]
- Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment) [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944929
|Contact: Nicolas Roche, MD||+ 33(1) 47 10 54 firstname.lastname@example.org|
|Contact: Bensmail Djamel, MD||+ 33(1) 47 10 70 email@example.com|
|Hôpital Raymond Poincaré||Recruiting|
|Garches, France, 92380|
|Principal Investigator:||Nicolas Roche, MD||Assistance Publique - Hôpitaux de Paris|