VSail: Virtual Sailing Simulator in Individuals With Spinal Cord Injury

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT01491789
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: The VSail-Access simulator
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Virtual Sailing Simulator in Individuals With Spinal Cord Injury
Study Start Date :
May 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Sailing

you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks

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 Names:
  • VSail-Access simulator
  • Outcome Measures

    Primary Outcome Measures

    1. ASIA Exam [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.

    Secondary Outcome Measures

    1. Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23 [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.

    2. Functional Reach Test, Level of Trunk Activation Test [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

    3. Grasp/Pinch test [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.

    4. Sailing Ability Questionnaire [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.

    5. ASIA Exam [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kennedy Krieger Institute Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    Investigators

    • Principal Investigator: Albert Recio, MD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Albert Recio, M.D., Faculty, Physician, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    ClinicalTrials.gov Identifier:
    NCT01491789
    Other Study ID Numbers:
    • NA_00044093
    First Posted:
    Dec 14, 2011
    Last Update Posted:
    Jan 10, 2022
    Last Verified:
    Jan 1, 2022
    Keywords provided by Albert Recio, M.D., Faculty, Physician, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 10, 2022