Clinical Evaluation of a Wheelchair Mounted Robotic Arm

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00011609
First received: February 22, 2001
Last updated: January 20, 2009
Last verified: January 2001

February 22, 2001
January 20, 2009
August 2000
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Complete list of historical versions of study NCT00011609 on ClinicalTrials.gov Archive Site
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Clinical Evaluation of a Wheelchair Mounted Robotic Arm
Clinical Evaluation of a Wheelchair Mounted Robotic Arm

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 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injury
Device: Robotic Arm
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2001
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Patients with spinal cord injuries

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00011609
B2311T
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Department of Veterans Affairs
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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
Department of Veterans Affairs
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP