Clinical trial NCT01936298: Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
Official title: Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand Edema
Exercise Therapy
Lead sponsor: Habilita, Ospedale di Sarnico
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 35
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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,
* aphasia,
* cognitive problems.

Primary outcomes:
measure: Change from Baseline of Perimeter edema
timeFrame: 1 day after the treatment
Secondary outcomes:
measure: Change from Baseline of Visual analogue scale (VAS)
timeFrame: 1 day after the treatment
measure: Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)
timeFrame: 1 day after the treatment
measure: Change from Baseline of Range Of Motion (ROM)
timeFrame: 1 day after the treatment
measure: Clinical Global Impression (CGI)
timeFrame: 1 day after the treatment
Other outcomes:
Locations:
city: Sarnico
country: Italy
facility: Habilita, Ospedale di Sarnico
state: Bergamo
Study officials:
affiliation: Habilita, Ospedale di Sarnico
name: Chiara Mulé, MD
role: PRINCIPAL_INVESTIGATOR
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