Study of Robot-assisted Arm Therapy for Acute Stroke Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Kessler Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Kessler Institute for Rehabilitation
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00785343
First received: November 4, 2008
Last updated: December 23, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Acute Stroke
Paresis
Device: Reo Go robotic arm trainer
Procedure: Conventional Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Adding Robotic Therapy to Conventional Therapy for Acute Stroke Patients With Upper Extremity Paresis

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Fugl-Meyer Score [ Time Frame: Start and end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EMG - muscle activation and co-contraction index [ Time Frame: Start and end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2008
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   65 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785343

Contacts
Contact: Lauren McDonagh, PT 201-368-6081 lmcdonagh@KESSLER-REHAB.com
Contact: Christine Post, OT 201-368-6247 CHPost@selectmedicalcorp.com

Locations
United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
Saddle Brook, New Jersey, United States, 07663
Contact: Lauren McDonagh    201-368-6081    lmcdonagh@KESSLER-REHAB.com   
Principal Investigator: Lauren McDonagh         
Sub-Investigator: Christine Post         
Sub-Investigator: Antoinette Gentile         
Sponsors and Collaborators
Kessler Foundation
Kessler Institute for Rehabilitation
Investigators
Principal Investigator: Lauren McDonagh, PT Kessler Rehabilitation Institute
  More Information

Publications:
Responsible Party: Kevin Terry, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00785343     History of Changes
Other Study ID Numbers: R-618-08
Study First Received: November 4, 2008
Last Updated: December 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Foundation:
stroke
acute
arm
robot
therapy
arm paresis

Additional relevant MeSH terms:
Paresis
Muscle Weakness
Stroke
Cerebral Infarction
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014