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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Information provided by (Responsible Party):
Albert Recio, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01491789
First received: December 6, 2011
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Spinal Cord Injury
Device: The VSail-Access simulator
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virtual Sailing Simulator in Individuals With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • ASIA Exam [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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:
  • Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23 [ Time Frame: Baseline, at 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: VSail-Access 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491789

Contacts
Contact: Shannon M Inches 443-923-9235 Inches@kennedykrieger.org

Locations
United States, Maryland
Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Shannon M Inches    443-923-9235    Inches@kennedkrieger.org   
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.
  More Information

No publications provided

Responsible Party: Albert Recio, M.D., Faculty, Physician, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01491789     History of Changes
Other Study ID Numbers: NA_00044093
Study First Received: December 6, 2011
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
spinal cord injury
Virtual sailing
Vsail

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 23, 2014