An interventional study of Experimental group and Control group in Stroke, sponsored by Fondazione Don Carlo Gnocchi ETS. Completed. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-17.
Sponsored by Fondazione Don Carlo Gnocchi ETS · Not applicable, Interventional, and Treatment
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).
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 32 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Fondazione Don Carlo Gnocchi ETS is the lead sponsor of 41 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Device: Experimental group · Device: traditional rehabilitation
Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Device: Control group · Device: traditional rehabilitation
Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.
Physiotherapy and occupational therapy.
Assisted stretching, shoulder and arm exercises, and functional reaching tasks
Change from National Institutes of Health Stroke Scale (NIHSS)
Time frame: baseline, immediately post-intervention (3 weeks).
Change from Visual analogue scale (VAS)
Time frame: baseline, immediately post-intervention (3 weeks).
Change from Barthel Index (BI)
Time frame: baseline, immediately post-intervention (3 weeks).
Change from Modified Ashworth Scale (MAS)
Time frame: baseline, immediately post-intervention
Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)
Time frame: baseline, immediately post-intervention (3 weeks).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Fondazione Don Carlo Gnocchi ETS