Spinal Cord InjuryVSailNCT01491789
Virtual Sailing Simulator in Individuals With Spinal Cord Injury
A study testing The VSail-Access simulator in people with Spinal Cord Injury, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- The VSail-Access simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
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.
Read the 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
- Being tested
- The VSail-Access simulator
- Keywords
- spinal cord injury, Virtual sailing, Vsail
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The VSail-Access simulatorDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Sailing | Experimental | you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks Receives: Device: The VSail-Access simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Recio, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Albert Recio, MD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491789
- Sponsor's protocol ID
- NA_00044093
- Acronym
- VSail
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2011
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Sailing Simulator in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01491789
- Acronym / sponsor ID
- VSail / NA_00044093
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, Virtual sailing, Vsail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Posted 9 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Sailing | Experimental | Device: The VSail-Access simulatoryou will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 .
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The VSail-Access simulatorAlso: VSail-Access simulatorYou 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. | Device | Virtual Sailing |
Primary outcome
Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23
Time frame: 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.
3 secondary outcomes
Functional Reach Test, Level of Trunk Activation Test
Time frame: Baseline
Grasp/Pinch Test
Time frame: Baseline
Sailing Ability Questionnaire
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Recio, MD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The VSail-Access simulator in people with Spinal Cord Injury, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23 (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.