Stroke Clinical Trial
Verified date | February 2016 |
Source | Universitat Pompeu Fabra |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.
Status | Completed |
Enrollment | 39 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of Hemorrhagic or ischemic stroke - Subject had the stroke more than 12 months ago. - Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale>2) secondary to a first-ever stroke. - Age between 45 and 85 years old. - Subject has previous experience using the RGS system in the clinic. Exclusion Criteria: - Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universitat Pompeu Fabra | Hospital del Mar, Hospital Vall d'Hebron |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | No | |
Secondary | Change in depression as measured by the Hamilton scale | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | No | |
Secondary | Change in motor function as measured by the Medical Research Council scale | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | No | |
Secondary | Change in spasticity for the upper arms as measured by the Ashworth scale | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | No | |
Secondary | Change in cognitive function as measured by the Mini-mental State Evaluation test | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | No | |
Secondary | Change in Grip Force as measured by a grip dynamometer | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | No | |
Secondary | Change in shoulder pain as measured by the Visual Analog Assessment scale | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | No | |
Secondary | Change in motor function as measured by the upper extremity Fugl-Meyer Assessment | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | No |
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