Have you or your loved ones been diagnosed with spinal cord injury?

You may be eligible to participate in a spinal cord injury clinical trial.

Have you or your loved ones been diagnosed with spinal cord injury? You may be eligible to participate in a spinal cord injury clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Spinal Cord Injury Clinical Trial in Baltimore MD

NCT01491789 | Interventional

Have you or your loved ones been diagnosed with spinal cord injury?

You may be eligible to participate in a spinal cord injury clinical trial.

Have you or your loved ones been diagnosed with spinal cord injury? You may be eligible to participate in a spinal cord injury clinical trial.

Completed

Male & Female

18 - 55

Years old

This study has recruited 18 Participants

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.

Show me more details

Details for the study

Brief Title

Virtual Sailing Simulator in Individuals With Spinal Cord Injury

Official Title

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 <br /> 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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

ASIA Exam

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.

Baseline

Secondary

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

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, at 6 weeks and 12 weeks

Secondary

Functional Reach Test, Level of Trunk Activation Test

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, at 6 weeks and 12 weeks

Secondary

Grasp/Pinch test

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 and 12 weeks

Secondary

Sailing Ability Questionnaire

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.

Baseline, at 6 weeks and 12 weeks

Secondary

ASIA Exam

at 6 weeks and 12 weeks

Study 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