Back to resultsClinical Evaluation of a Wheelchair Mounted Robotic Arm
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Robotic Arm
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Robotics; Activities of Daily Living; Spinal Cord Injuries
Eligibility Criteria
Patients with spinal cord injuries
Sites / Locations
- VAMC, Houston
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00011609
First Posted
February 22, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00011609
Brief Title
Clinical Evaluation of a Wheelchair Mounted Robotic Arm
Official Title
Clinical Evaluation of a Wheelchair Mounted Robotic Arm
Study Type
Interventional
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Robotics; Activities of Daily Living; Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Robotic Arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with spinal cord injuries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fryer, Ph.D. Asst. Director
Organizational Affiliation
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
First Name & Middle Initial & Last Name & Degree
Nancy Rocheleau, Program Analyst
Organizational Affiliation
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Facility Information:
Facility Name
VAMC, Houston
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of a Wheelchair Mounted Robotic Arm
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