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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-rehabilitation program | Experimental | Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy) |
|
| Control arm | No Intervention | Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-rehabilitation program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Goal Attainment Scaling (GAS). | The percentage of patients who attain their Primary Treatment Goal determined using Goal Attainment Scaling (GAS) at each visits and in both groups. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Functional Independence Measure (FIM) | 6 months | |
| Assessment of Hemispatial neglect | 6 months | |
| Quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Roche, MD | Contact | + 33(1) 47 10 54 09 | roche.nicolas@aphp.fr | |
| Bensmail Djamel, MD | Contact | + 33(1) 47 10 70 60 | djamel.bensmail@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Roche, MD | Assistance Publique - HĂ´pitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Raymond Poincaré | Recruiting | Garches | 92380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30166290 | Derived | 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. |
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|
| 6 months |
| Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment) | 6 months |
| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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