search
Back to results

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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The VSail-Access simulator
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, Virtual sailing, Vsail

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Sailing

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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.
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.

Full Information

First Posted
December 6, 2011
Last Updated
December 12, 2022
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01491789
Brief Title
Virtual Sailing Simulator in Individuals With Spinal Cord Injury
Acronym
VSail
Official Title
Virtual Sailing Simulator in Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2022 (Actual)
Study Completion Date
August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, Virtual sailing, Vsail

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Sailing
Arm Type
Experimental
Arm Description
you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks
Intervention Type
Device
Intervention Name(s)
The VSail-Access simulator
Other Intervention Name(s)
VSail-Access simulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
ASIA Exam
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23
Description
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.
Time Frame
Baseline, at 6 weeks and 12 weeks
Title
Functional Reach Test, Level of Trunk Activation Test
Description
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
Time Frame
Baseline, at 6 weeks and 12 weeks
Title
Grasp/Pinch test
Description
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.
Time Frame
Baseline and 12 weeks
Title
Sailing Ability Questionnaire
Description
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.
Time Frame
Baseline, at 6 weeks and 12 weeks
Title
ASIA Exam
Description
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.
Time Frame
at 6 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Recio, MD
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Virtual Sailing Simulator in Individuals With Spinal Cord Injury

We'll reach out to this number within 24 hrs