Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Chiara Mulé
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Change from Baseline of Perimeter edema
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.
Detailed Description
We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke. We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.
Investigators
Chiara Mulé
Physiatrist Physician
Habilita, Ospedale di Sarnico
Eligibility Criteria
Inclusion Criteria
- •a history of acute phase of stroke (less than 12 months post onset),
- •first stroke episode,
- •no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,
- •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 before the start of this study,
- •for P-ROM patients, the absence of active hand movements,
- •for the A-ROM patients, the presence of active hand movements.
Exclusion Criteria
- •unstable medical disorders,
- •active Complex Regional Pain Syndrome (CRPS),
- •severe spatial neglect,
- •cognitive problems.
Outcomes
Primary Outcomes
Change from Baseline of Perimeter edema
Time Frame: 1 day after the treatment
Secondary Outcomes
- Change from Baseline of Visual analogue scale (VAS)(1 day after the treatment)
- Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)(1 day after the treatment)
- Change from Baseline of Range Of Motion (ROM)(1 day after the treatment)
- Clinical Global Impression (CGI)(1 day after the treatment)