Stroke
Conditions
Keywords
Hand Edema, Exercise Therapy
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.
Interventions
DEVICEA-ROM Continuous Passive Rehabilitation
Half an hour of treatment during the morning with the sequential program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the synchronous program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
DEVICEP-ROM Continuous Passive Rehabilitation
Half an hour of treatment during the morning with the sequential program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the synchronous program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
Sponsors
Chiara Mulé
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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, * aphasia, * cognitive problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline of Perimeter edema | 1 day after the treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Outcome results
None listed