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The objectives of this phase II clinical study are: evaluate the efficacy, safety, patient adeherence and clinical applicability of a new robotic device for patients with stroke at a physical rehabilitation institution (Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Universidade de São Paulo - IMREA HCFMUSP - Rede de Reabilitação Lucy Montoro, unidade Vila Mariana). Methods: 10 patients with stroke diagnosis and Fugl-Meyer score ranging from 34 to 55 will be selected to be included in the study. After signing the informed consent form and being assessed by the baseline evaluations, they will undertake 18 sessions of robotic therapy, which in its turn will be prescribed three times a week. After this period, the patients will be evaluated for future comparison of both the pre-treatment and final assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Therapy | Experimental | After consent, 10 participants will be included in a training program, as described below: 1º session will be robotic calibration and assessment; the following 18 sessions will be conducted the robotic therapy for upper limbs, three times a week. Each session will have a total duration of 55 minutes, including initial patient positioning and adjusting and after a sequence of game tasks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Therapy | Device | Robotic Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Assessment Upper Limb (FMA-UL) | FMA-UL evaluates the recovery of the hemiplegic patient after stroke. It includes the measurement of reflex activity, movement with and without synergy, voluntary movements and coordination of shoulder, elbow, wrist, hand. | Mean change from baseline at six weeks (19 sessions of robotic therapy). |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test (WMFT) | WMFT evaluates time performance and functional ability in 17 unimanual tasks. | Mean change from baseline at six weeks (19 sessions of robotic therapy). |
| Dynamometry - Grasp and Pinch |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical feasibility | Time necessary to adjust the device; patients satisfaction questionnaire. | Reported during 6 weeks treatment, in each session. |
Inlcusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação | São Paulo | 04116-040 | Brazil |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Instrument to measure palmar and lateral grip (strength in kgf).
| Mean change from baseline at six weeks (19 sessions of robotic therapy). |
| Patients safety | Adverse effects questionnaire applied in each session. | Adverse effects reported during 6 weeks treatment. |
| Treatment adherence | Number of patients withdrawing from treatment without justification (drop outs). | Drop outs reported during 6 weeks treatment. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |