Virtual Sailing Simulator in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23
时间窗: 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.
次要结局
- Functional Reach Test, Level of Trunk Activation Test(Baseline)
- Sailing Ability Questionnaire(Baseline)
- Grasp/Pinch Test(Baseline)
研究者
Albert Recio, M.D.
Faculty, Physician
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.