Clinical trial NCT01491789: Virtual Sailing Simulator in Individuals With Spinal Cord Injury
Official title: Virtual Sailing Simulator in Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
Virtual sailing
Vsail
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2011-12-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 criteria: 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

Primary outcomes:
measure: Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23
timeFrame: Baseline
Secondary outcomes:
measure: Functional Reach Test, Level of Trunk Activation Test
timeFrame: Baseline
measure: Grasp/Pinch Test
timeFrame: Baseline
measure: Sailing Ability Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Albert Recio, MD
role: PRINCIPAL_INVESTIGATOR
References: