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Trial record 4 of 212 for:    Acute Stroke | United States

Study of Robot-assisted Arm Therapy for Acute Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00785343
Recruitment Status : Unknown
Verified December 2009 by Kessler Foundation.
Recruitment status was:  Recruiting
First Posted : November 5, 2008
Last Update Posted : December 24, 2009
Kessler Institute for Rehabilitation
Information provided by:
Kessler Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Stroke Paresis Device: Reo Go robotic arm trainer Procedure: Conventional Therapy Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Adding Robotic Therapy to Conventional Therapy for Acute Stroke Patients With Upper Extremity Paresis
Study Start Date : September 2008

Arm Intervention/treatment
Active Comparator: Conventional Treatment Procedure: Conventional Therapy
Occupational therapy that is the current standard of care

Experimental: Robotic and Conventional Therapy Device: Reo Go robotic arm trainer
Robotic training with the Reo Go is included with conventional treatment during daily OT sessions

Primary Outcome Measures :
  1. Fugl-Meyer Score [ Time Frame: Start and end of treatment ]

Secondary Outcome Measures :
  1. EMG - muscle activation and co-contraction index [ Time Frame: Start and end of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years to 84 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00785343

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Contact: Lauren McDonagh, PT 201-368-6081
Contact: Christine Post, OT 201-368-6247

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United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
Saddle Brook, New Jersey, United States, 07663
Contact: Lauren McDonagh    201-368-6081   
Principal Investigator: Lauren McDonagh         
Sub-Investigator: Christine Post         
Sub-Investigator: Antoinette Gentile         
Sponsors and Collaborators
Kessler Foundation
Kessler Institute for Rehabilitation
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Principal Investigator: Lauren McDonagh, PT Kessler Rehabilitation Institute

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Responsible Party: Kevin Terry, Kessler Foundation Identifier: NCT00785343    
Other Study ID Numbers: R-618-08
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: December 2009
Keywords provided by Kessler Foundation:
arm paresis
Additional relevant MeSH terms:
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Muscle Weakness
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes