Virtual Sailing Simulator in Individuals With Spinal Cord Injury

NCT ID: NCT01491789

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2022-08-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Sailing

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

Group Type: EXPERIMENTAL

The VSail-Access simulator

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

VSail-Access simulator

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Albert Recio, M.D.

Faculty, Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert Recio, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

NA_00044093

Identifier Type: -

Identifier Source: org_study_id