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Clinical Evaluation of a Wheelchair Mounted Robotic Arm

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00011609
  Purpose

The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI.

The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm:

1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.


Condition Intervention Phase
Spinal Cord Injury
Device: Robotic Arm
Phase II

MedlinePlus related topics:   Spinal Cord Injuries   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:   Clinical Evaluation of a Wheelchair Mounted Robotic Arm

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:   30
Study Start Date:   August 2000
Study Completion Date:   November 2001

Detailed Description:

The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI.

The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm:

1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.

The secondary purposes of this project are the following: 1.Does quality of life (life satisfaction and health status) improve after a 4 week period of using the WMRA? 2. What are the perceived advantages of the WMRA to the veteran with SCI? Additionally, the study will evaluate the following: 1) ease of installation and usefulness of instructional manuals; 2) training requirements (time, tasks); 3) safety features; 4) reliability of the device; 5) home, community, and vocational applications; 6) user acceptability; 7) maintenance/ service; 8) portability; and possible modifications.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Patients with spinal cord injuries

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011609

Locations
United States, Texas
VAMC, Houston    
      Houston, Texas, United States

Sponsors and Collaborators

Investigators
Investigator:     John Fryer, Ph.D. Asst. Director     Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service    
Investigator:     Nancy Rocheleau, Program Analyst     Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service    
  More Information


Study ID Numbers:   B2311T
First Received:   February 22, 2001
Last Updated:   December 12, 2007
ClinicalTrials.gov Identifier:   NCT00011609
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Robotics; Activities of Daily Living; Spinal Cord Injuries  

Study placed in the following topic categories:
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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