Virtual Sailing Simulator in Individuals With Spinal Cord Injury (VSail)

Tracking Information
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; (submitted: December 12, 2011)	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.
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; (submitted: December 12, 2011)	Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23 [ Time Frame: Baseline, at 6 weeks and 12 weeks ]This is a routine test performed for people with spinal cord injury. The SCI QL-23 is a 23-item health-related quality of life questionnaire. The subject will read the questionnaire and answer the questions; if needed ,assistance will be provided to record the answers on the form. The SCI QL-23 questionnaire will be used for all subjects.; Functional Reach Test, Level of Trunk Activation Test [ Time Frame: Baseline, at 6 weeks and 12 weeks ]Two different assessments of how you are able to use your trunk will be performed. This test is performed by patient reaching forward as far as they can while seated in their wheelchair.This test will assess the activation of trunk muscle by asking the patient to perform a sit-up from the supine position; Grasp/Pinch test [ Time Frame: Baseline and 12 weeks ]This is a routine test performed for people with spinal cord injury. This is a standard test used to assess strength of grasp and lateral pinch. The Jamar dynamometer will be used to assess grasp and lateral pinch. This test will be performed on all subjects.; Sailing Ability Questionnaire [ Time Frame: Baseline, at 6 weeks and 12 weeks ]This is a routine test performed for people involved in a training program. This questionnaire will assess the subject's views about sailing, as well as the subject's perceived sailing abilities.; ASIA Exam [ Time Frame: at 6 weeks and 12 weeks ]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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
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
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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: December 12, 2011)	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: Males and Females, age 18-55 years, all ethnic groups.; Spinal Cord Injury.; Chronic injury, > 6 months from the injury.; All ASIA neurological levels (C1-S1); All ASIA impairment scale A-D .; Subjects are able to comply with procedures and follow-up.; Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues. Exclusion Criteria: Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke NYHA Class III or IV, history of arrhythmia with hemodynamic instability.; Uncontrolled hypertension (resting systolic BP > 160mmHg, or diastolic BP > 100mmHg consistently).; Severe hypotension (systolic BP < 80 mmHg, or diastolic BP < 55 mmHg).; Ventilator dependent subjects.; Significant cognitive impairment.; History of epileptic seizures.; Unstable long bone fractures of the extremities.; Subjects having Stage III or greater skin ulcerations.; Active sailor.; Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Shannon M Inches 443-923-9235 Inches@kennedykrieger.org
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	Principal Investigator: Albert Recio, MD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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