- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01491789
Virtual Sailing Simulator in Individuals With Spinal Cord Injury (VSail)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Kennedy Krieger Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and Females, age 18-65 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual Sailing
you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23
Time Frame: Baseline
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Reach Test, Level of Trunk Activation Test
Time Frame: Baseline
|
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
|
Baseline
|
Grasp/Pinch Test
Time Frame: Baseline
|
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.
|
Baseline
|
Sailing Ability Questionnaire
Time Frame: Baseline
|
This questionnaire will assess the subject's views about sailing, as well as the subject's perceived sailing abilities.
This is a yes or no survey, Zero is no, One is yes.
One means you have sailed before and zero means you have not sailed before.
minimum score is 0 and maximum score is 1.
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Albert Recio, MD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00044093
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injury
-
Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
-
University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
NervGen PharmaRecruitingSpinal Cord Injuries | Chronic Spinal Cord Injury | Subacute Spinal Cord InjuryUnited States
-
MetroHealth Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS); Case Western...RecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury CervicalUnited States
-
Kevin KilgoreNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States
-
The University of Texas Health Science Center,...TerminatedSpinal Cord Injuries | Cervical Spinal Cord Injury | Traumatic Spinal Cord CompressionUnited States
-
StemCells, Inc.TerminatedStudy of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord InjuryCervical Spinal Cord Injury | Spine Injury | Cervical Spine InjuryUnited States, Canada
-
S.Biomedics Co., Ltd.Yonsei University; Linical Co., Ltd.RecruitingSpinal Cord Injury, Acute | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C4 Level With Complete LesionKorea, Republic of
-
Kessler FoundationNew Jersey Commission on Spinal Cord ResearchRecruitingSpinal Cord Injuries | Incomplete Spinal Cord InjuryUnited States
Clinical Trials on The VSail-Access simulator
-
Odense University HospitalCompletedHealth Knowledge, Attitudes, Practice | Downs SyndromeDenmark
-
Providence VA Medical CenterUS Department of Veterans AffairsUnknownVeterans | Nursing Home | Quality of Care | Functional Impairment
-
Colorado State UniversityCompletedMultiple SclerosisUnited States
-
Minneapolis Heart Institute FoundationRecruitingPatient Satisfaction | Vascular Access ComplicationUnited States
-
Assistance Publique Hopitaux De MarseilleUnknown
-
Jeffrey HazeyNatural Orifice Surgery Consortium for Assessment and Research; Stryker SACompleted
-
University of California, San FranciscoCompletedHIV Infections | Health LiteracyUnited States
-
University Hospital, MontpellierEDOPRecruiting
-
Talon SurgicalCompleted
-
The University of Texas Health Science Center,...CompletedSocial Determinants of HealthUnited States