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Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients

NCT00372411 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2014-01-13

Study results available
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Summary

This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Albert Lo, MD PhD · Providence VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2009-07-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00372411 on ClinicalTrials.gov