Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 2

Conditions: Stroke

Treatments: Other: Traditional Supervised Upper Extremity Exercises; Device: Upper extremity robot

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00037934

B2436

Details and patient eligibility

About

We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Stroke
• Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm

Exclusion criteria

• Acute Stroke
• Contracture or orthopedic problems limiting the movement of the affected arm
• Visual deficit such that the participant cannot see the test pattern on the robot trainer
• Serious complicating medical illness
• Botox treatment to the involved arm within three months of enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups

1

Experimental group

Description:

Robot exercise group

Treatment:

Device: Upper extremity robot

2

Active Comparator group

Description:

Traditional exercise group

Treatment:

Device: Upper extremity robot

Other: Traditional Supervised Upper Extremity Exercises