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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 22, 2001 | ||||||||
| Last Updated Date | January 20, 2009 | ||||||||
| Start Date ICMJE | August 2000 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00011609 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clinical Evaluation of a Wheelchair Mounted Robotic Arm | ||||||||
| Official Title ICMJE | Clinical Evaluation of a Wheelchair Mounted Robotic Arm | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Spinal Cord Injury | ||||||||
| Intervention ICMJE | Device: Robotic Arm | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 30 | ||||||||
| Completion Date | November 2001 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Patients with spinal cord injuries |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00011609 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | B2311T | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | January 2001 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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