Spinal Cord Injury
Conditions
Keywords
spinal cord injury, Virtual sailing, Vsail
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.
Interventions
DEVICEThe 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.
Sponsors
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23 | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Reach Test, Level of Trunk Activation Test | 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 |
| Grasp/Pinch Test | 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. |
| Sailing Ability Questionnaire | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Sailing you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks
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. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Virtual Sailing | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 17 Participants | — |
| Age, Continuous | 45 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 17 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
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.
Time frame: Baseline
Population: Scale of 0-100, higher values represent better outcome
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Sailing | Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23 | 48.2 score on a scale |
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
Time frame: Baseline
Population: score on a scale of 0-30 higher values represent better outcome
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Sailing | Functional Reach Test, Level of Trunk Activation Test | 13.4 units on a scale |
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.
Time frame: Baseline
Population: score on a scale from 0-200 higher values represent better outcome
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Sailing | Grasp/Pinch Test | 55 units on a scale |
Secondary
Sailing Ability Questionnaire
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.
Time frame: Baseline
Population: higher values represent better outcome
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Sailing | Sailing Ability Questionnaire | 1 units on a scale |