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| 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 |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2000 |
| Study Completion Date: | November 2001 |
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 |
Patients with spinal cord injuries
Contacts and Locations| United States, Texas | |
| VAMC, Houston | |
| Houston, Texas, United States | |
| 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 |
| Study First Received: | February 22, 2001 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00011609 History of Changes |
| Health Authority: | United States: Federal Government |
|
Robotics; Activities of Daily Living; Spinal Cord Injuries |
|
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
|
Spinal Cord Injuries Spinal Cord Diseases Nervous System Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
