N/A
Completed N=18
Virtual Sailing Simulator in Individuals With Spinal Cord Injury
Source: ClinicalTrials.gov NCT01491789 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23 — 48.2 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23 |
48.2 | — |
| SECONDARY Functional Reach Test, Level of Trunk Activation Test |
13.4 | — |
| SECONDARY Grasp/Pinch Test |
55 | — |
| SECONDARY Sailing Ability Questionnaire |
1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01491789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.