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

Chiara Mulé

Status: Completed

Conditions: Stroke

Treatments: Device: P-ROM Continuous Passive Rehabilitation; Device: A-ROM Continuous Passive Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01936298

GLO01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

A-ROM Continuous Passive Rehabilitation

Experimental group

Description:

The group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.

Treatment:

Device: A-ROM Continuous Passive Rehabilitation

P-ROM Continuous Passive Rehabilitation

Experimental group

Description:

The group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.

Treatment:

Device: P-ROM Continuous Passive Rehabilitation