Study of Robot-assisted Arm Therapy for Acute Stroke Patients

December 23, 2009 updated by: Kessler Foundation

Effectiveness of Adding Robotic Therapy to Conventional Therapy for Acute Stroke Patients With Upper Extremity Paresis

The purpose of this study is to compare standard occupational therapy to a combination of conventional (standard) and robotic therapy. The Reo Go device will provide robotic therapy that gives therapists a tool that could make stroke treatment faster and better by helping patients practice more accurate arm movements with help from the device.

Study Overview

Detailed Description

HYPOTHESES

  • Motor function will be significantly greater for the patients in the robotic training group as measured by standard clinical evaluations.
  • Functional independence gains will be similar for both groups because the robotic therapy is not task-specific for activities of daily living (ADL).
  • Robotic training will reduce pain and spasticity more effectively than conventional therapy alone, due to increased number of movements performed during the robotic training.
  • Muscle activation patterns for patients receiving robotic training will show decreased agonist/antagonist co-contraction and less erratic muscle activation.
  • Robotic training patients will demonstrate significantly greater ROM, movement accuracy and higher movement speed during exercises performed as part of robotic training. For robotic exercises performed only as part of the robotic assessment, these improvements will be significantly less than those for practiced movements.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • New Jersey
      • Saddle Brook, New Jersey, United States, 07663
        • Recruiting
        • Kessler Institute for Rehabilitation
        • Contact:
        • Principal Investigator:
          • Lauren McDonagh
        • Sub-Investigator:
          • Christine Post
        • Sub-Investigator:
          • Antoinette Gentile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 84 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria Right hemisphere, unilateral ischemic stroke with onset of less than 15 days that results in arm weakness Right-handed 65-84 years of age Manual Muscle Test score of at least 2/5 Must be able to follow 2-3 step commands Head, neck, and trunk control to maintain an upright posture for a minimum of 45 minutes Some synergistic movement at shoulder Active shoulder flexion and/or abduction greater then 30 degrees Active elbow flexion of 45 degrees or more

Exclusion criteria

  • Previous stroke history
  • Hemorrhagic stroke, cerebellar stroke, or subarachnoid hemorrhage
  • Contractures in the involved upper extremity at the shoulder, elbow, or wrist
  • Moderate to severe tone in the involved upper extremity
  • Flaccid involved upper extremity
  • Full, active isolated movement of the involved upper extremity
  • Corrected visual acuity worse than 20/50 for distance
  • Cognitive or other deficits that would negatively affect their ability to follow directions or track visual targets
  • Unstable cardiovascular orthopedic or neurological conditions that would preclude exercise in short-duration, high work-load trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Treatment
Occupational therapy that is the current standard of care
EXPERIMENTAL: Robotic and Conventional Therapy
Robotic training with the Reo Go is included with conventional treatment during daily OT sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Score
Time Frame: Start and end of treatment
Start and end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
EMG - muscle activation and co-contraction index
Time Frame: Start and end of treatment
Start and end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lauren McDonagh, PT, Kessler Rehabilitation Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 4, 2008

First Posted (ESTIMATE)

November 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

December 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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