Virtual Sailing Simulator in Individuals With Spinal Cord Injury (VSail)
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ClinicalTrials.gov Identifier: NCT01491789 |
Recruitment Status
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Recruiting
First Posted
: December 14, 2011
Last Update Posted
: February 20, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | December 6, 2011 | ||||
First Posted Date ICMJE | December 14, 2011 | ||||
Last Update Posted Date | February 20, 2018 | ||||
Study Start Date ICMJE | May 2011 | ||||
Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
ASIA Exam [ Time Frame: Baseline ] This is a routine test performed for people with spinal cord injury. The ASIA (American Spinal Injury Association) exam assesses motor function at 10 key muscles in the body and light touch and pinprick sensation at 28 key points on each side of the body. It is also used to classify injury level and severity. This test will be performed on all subjects.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01491789 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Virtual Sailing Simulator in Individuals With Spinal Cord Injury | ||||
Official Title ICMJE | Virtual Sailing Simulator in Individuals With Spinal Cord Injury | ||||
Brief Summary | The research is being done to look at the benefits of a recreational and therapeutic program for people with spinal cord injury using the VSail-Access sailing simulator. | ||||
Detailed Description | The VSail-Access is the first sailing simulator available for people with disabilities. The VSail-Access simulator is a variation on the VSail where the cockpit is fitted with a seat. The VSail simulator is a generic sailboat cockpit powered by a pneumatic ram and custom designed software. The sailor sails the simulator around virtual courses displayed on a computer screen in the same way as a real sailboat on water. Electronic sensors provide real time feedback to match the movements of the virtual sailboat displayed on the screen with those of the simulator. Sailors can select wind strength and conditions to suit their ability. Adults with spinal cord injury may take part in this study. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Spinal Cord Injury | ||||
Intervention ICMJE | Device: The VSail-Access simulator
You will be transferred to the VSail cockpit and secured. Following the trainer's instruction, you will sail the simulator around virtual courses displayed on a computer screen, using a joystick to control the rudder angle and a mainsheet to control the set of the sail. You will do this for 1 hour.
Other Name: VSail-Access simulator |
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Study Arms | Experimental: Virtual Sailing
you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks
Intervention: Device: The VSail-Access simulator |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date | December 2018 | ||||
Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01491789 | ||||
Other Study ID Numbers ICMJE | NA_00044093 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Albert Recio, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | ||||
Study Sponsor ICMJE | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | ||||
Verification Date | February 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |