Stroke Clinical Trial
Official title:
Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial
Verified date | March 2016 |
Source | Fondazione Don Carlo Gnocchi Onlus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | June 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: - acute phase of stroke - first stroke episode. - no history of peripheral nerve injury or musculoskeletal disease - no contracture of the affected wrist or fingers (Modified Ashworth<3) - no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months prior to the start of this study. - paralysis of the wrist and fingers Exclusion Criteria: - unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems. - scored greater than 4 points on the Beck Depression Inventory (BDI) - more than 30 points in the State Trait Anxiety Inventory (STAI) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from National Institutes of Health Stroke Scale (NIHSS) | baseline, immediately post-intervention (3 weeks). | Yes | |
Secondary | Change from Visual analogue scale (VAS) | baseline, immediately post-intervention (3 weeks). | Yes | |
Secondary | Change from Barthel Index (BI) | baseline, immediately post-intervention (3 weeks). | Yes | |
Secondary | Change from Modified Ashworth Scale (MAS) | baseline, immediately post-intervention | Yes | |
Secondary | Change from Disabilities of the Arm, Shoulder and Hand (quickDASH) | baseline, immediately post-intervention (3 weeks). | Yes |
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