Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

July 31, 2009

Study Completion Date

August 31, 2009

Conditions
Stroke
Interventions
DEVICE

Robot-Assisted Therapy - MIT-MANUS System

The MIT-MANUS robot consists of four modules to train the entire upper limb: module A: shoulder-elbow; module B: anti-gravity; module C: wrist, and module D: hand-unit. Training will be given for 12 weeks and is divided into 4 consecutive blocks, with 9 training sessions per block.

OTHER

Intensive Comparison Therapy

The intensive comparison therapy protocol being used in CSP#558 was developed and field-tested at the Burke Rehabilitation Hospital. It exposes the patient to the identical number of treatments, time, and intensity that robot treated patients will receive (12 weeks, 3 times per week). Therapy sessions can be conducted on back-to-back days if needed and on more than 3 days a week (with approval from the Study Chairman) over a treatment period of up to 14 weeks in order to complete the 36 treatment sessions. During each 1-hour session, subjects participate in therapy in four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques (NDT)/Bobath arm training (Bobath, 1979).

OTHER

Usual Care

The usual chronic stroke care as delivered at each participating medical center

Trial Locations (5)

21201

VA Maryland Health Care System, Baltimore, Baltimore

32608

North Florida/South Georgia Veterans Health System, Gainesville

98108

VA Puget Sound Health Care System, Seattle, Seattle

06516

VA Connecticut Health Care System (West Haven), West Haven

02908-4799

Providence VA Medical Center, Providence

Sponsors
All Listed Sponsors
collaborator

Burke Medical Research Institute

OTHER

lead

US Department of Veterans Affairs

FED