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Robotics For Rehabilitation Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01050231
First received: February 21, 2008
Last updated: March 28, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to develop an upper extremity robotic training system for use by people with stroke to practice arm and hand movement in the clinic.


Condition Intervention Phase
Cerebrovascular Accident
 Device: Type I Robotic Group (Functional activities and individual joints)
Device: Type II Robotic therapy (Individual joints only)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotics For Rehabilitation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Motor and strength measure using Box & Block and Fugl-Meyer tests [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: October 2006
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Robotic group(Type I)
 Device: Type II Robotic therapy (Individual joints only)
Subjects participate in 11 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements as the patient plays interactive computer games.
Active Comparator: 2
Robotic group (Type II)
 Device: Type I Robotic Group (Functional activities and individual joints)
Subjects participate in 11 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder) , 3 days per week, 1 hour per day with the robotic exercise program.

Detailed Description:

Each year in the U.S. over 400,000 people survive a stroke and approximately 80% of acute stroke survivors lose arm and hand movement skills. Movement impairments are typically treated with intensive, hands-on physical and occupational therapy for several weeks after the initial brain injury. Unfortunately, due to economic pressure on the U.S. health care system, stroke patients are receiving less therapy and going home sooner. Our goal for this study is to develop an upper extremity robotic training system for both acute and chronic stroke population to improve movement ability with intensive and repetitive movement in the clinic without continuous supervision from a therapist.

  Eligibility

Ages Eligible for Study:   18 Years to 73 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 73
  • Sustained single stroke at least three months previously
  • Minimal to moderate lost motor control of the arm after stroke

Exclusion Criteria:

  • Concurrent severe medical problems
  • Severe cognitive dysfunction
  • Severe neglect or apraxia
  • Severe visual deficits
  • Significant subluxation of the shoulder
  • Presence of severe elbow or wrist contracture
  • Any metal implants or surgical clips or mechanical devices
  • Metallic hardware on scalp region
  • prior diagnosis of seizure and epilepsy
  • severe migraine headache
  • currently pregnant or lactating
  • claustrophobic
  • currently taking medication that lower seizure threshold
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050231

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: David J Reinkensmeyer, Ph.D University of California, Irvine
  More Information

No publications provided

Responsible Party: David J. Reinkensmeyer, Ph.D., Professor of Mechanical and Aerospace Engineering, University of Californa, Irvine
ClinicalTrials.gov Identifier: NCT01050231     History of Changes
Other Study ID Numbers: HS#2005-4506
Study First Received: February 21, 2008
Last Updated: March 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
stroke
cerebrovascular accident
robot

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013