Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

N/ACompletedNCT01936298

Chiara Mulé35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke

Interventions

A-ROM Continuous Passive RehabilitationDEVICE

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).

P-ROM Continuous Passive RehabilitationDEVICE

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Habilita, Ospedale di Sarnico

Sarnico, Bergamo, Italy