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Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.
The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week). |
|
| Control group | Active Comparator | Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental group | Device | Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from National Institutes of Health Stroke Scale (NIHSS) | baseline, immediately post-intervention (3 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Visual analogue scale (VAS) | baseline, immediately post-intervention (3 weeks). | |
| Change from Barthel Index (BI) | baseline, immediately post-intervention (3 weeks). | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JORGE H VILLAFAÑE, PhD | IRCCS Don Gnocchi Foundation | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 10, 2020 | |
| Reset | Aug 24, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 10, 2020 | Aug 24, 2020 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D010243 | Paralysis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Device | Physiotherapy and occupational therapy. |
|
| traditional rehabilitation | Device | Assisted stretching, shoulder and arm exercises, and functional reaching tasks |
|
| Change from Modified Ashworth Scale (MAS) |
| baseline, immediately post-intervention |
| Change from Disabilities of the Arm, Shoulder and Hand (quickDASH) | baseline, immediately post-intervention (3 weeks). |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |