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Completed

NCT Number: NCT01491789

Virtual Sailing Simulator in Individuals With Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The VSail-Access simulator

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: VSail

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2011
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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