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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire Vaudois | OTHER |
| Swiss Commission for Technology and Innovation | OTHER |
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The purpose of this study is to determine whether intensive, focused training of the affected upper extremity after stroke results in long-term functional gains in moderately-to-severely paralyzed patients, more than 6 months after their vascular accident. During the course of therapy, user's attempts to move and complete exercises are assisted by neuromuscular electrical stimulation.
This pilot study quantifies functional gains induced by the Electrically Assisted Movement Therapy (EAMT), an extension of Constraint-Induced Movement Therapy to moderately-to-severely paralyzed patients in their stable plateau phase of recovery. During EAMT, patients can assist affected upper limb movements through functional electrical stimulation. Initially, patients are divided in two groups. One of the groups receives EAMT, the other receives the best possible physical and occupational therapy. Therapy consists in 40 sessions of 45 minutes twice per day over five weeks, including a one-week therapy break. After 20 sessions, group allocation is crossed-over, and patients don't receive any therapy for one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EAMT, then standard care | Experimental | Electrically Assisted Movement Therapy precedes usual and customary care. |
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| Standard care, then EAMT | Active Comparator | Usual and customary care precedes Electrically Assisted Movement Therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrically Assisted Movement Therapy | Other | Electrically Assisted Movement Therapy (EAMT) is an extension of conventional Constraint-Induced Movement Therapy (CIMT) for moderately-to-severely paralyzed patients. During EAMT, patients use a movement controller with the healthy hand, controlling movements generated through neuromuscular electrical stimulation of the paralyzed arm and hand. During each session three types of exercises can be performed: mobilization, games, and training for activities of daily living, all three involving proper shaping of exercise difficulty at therapist discretion. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE), | A quantitative measure of motor impairment. | T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | Quality and time of task performance | T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment) |
| Modified Ashworth scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Carda, MD, PhD | Neuropsychology and Neurorehabilitation Service, Centre hospitalier universitaire vaudois (CHUV) | Principal Investigator |
| José del R. Millán, Prof. | Defitech Foundation Chair in Brain-machine Interface, Swiss Federal Institute of Technology Lausanne (EPFL) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neuropsychologie et neuroréhabilitation - CHUV | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28499657 | Derived | Carda S, Biasiucci A, Maesani A, Ionta S, Moncharmont J, Clarke S, Murray MM, Millan JDR. Electrically Assisted Movement Therapy in Chronic Stroke Patients With Severe Upper Limb Paresis: A Pilot, Single-Blind, Randomized Crossover Study. Arch Phys Med Rehabil. 2017 Aug;98(8):1628-1635.e2. doi: 10.1016/j.apmr.2017.02.020. Epub 2017 May 9. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Usual and customary care | Other | Usual and customary care ranges from no treatment to varying amounts of orthotics, home-based and clinic-based occupational therapy, or physiotherapy, but always excludes CIMT and EAMT. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks, whenever possible, to match EAMT amount of therapy. |
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A quantitative measure of hand and arm spasticity |
| T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment) |
| European stroke scale | Overall functional status | T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment) |
| Motor Activity Log | Semi-structured interview to assess arm function. | T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |