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| Tracking Information | |||||||||
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| First Received Date † | February 22, 2001 | ||||||||
| Last Updated Date | January 20, 2009 | ||||||||
| Start Date † | August 2000 | ||||||||
| Current Primary Outcome Measures † | |||||||||
| Original Primary Outcome Measures † | |||||||||
| Change History | Complete list of historical versions of study NCT00011609 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Clinical Evaluation of a Wheelchair Mounted Robotic Arm | ||||||||
| Official Title † | 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 † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition † | Spinal Cord Injury | ||||||||
| Intervention † | 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 † | Completed | ||||||||
| Enrollment † | 30 | ||||||||
| Completion Date | November 2001 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Patients with spinal cord injuries |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00011609 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Department of Veterans Affairs | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | January 2001 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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