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Trial record 17 of 294 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

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

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ClinicalTrials.gov Identifier: NCT01491789
Recruitment Status : Recruiting
First Posted : December 14, 2011
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Albert Recio, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

December 6, 2011
December 14, 2011
February 20, 2018
May 2011
December 2018   (Final data collection date for primary outcome measure)
ASIA Exam [ Time Frame: Baseline ]
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.
Same as current
Complete list of historical versions of study NCT01491789 on ClinicalTrials.gov Archive Site
  • Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23 [ Time Frame: Baseline, at 6 weeks and 12 weeks ]
    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 [ Time Frame: Baseline, at 6 weeks and 12 weeks ]
    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 [ Time Frame: Baseline and 12 weeks ]
    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 [ Time Frame: Baseline, at 6 weeks and 12 weeks ]
    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 [ Time Frame: at 6 weeks and 12 weeks ]
    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.
Same as current
Not Provided
Not Provided
 
Virtual Sailing Simulator in Individuals With Spinal Cord Injury
Virtual Sailing Simulator in Individuals With Spinal Cord Injury
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.

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinal Cord Injury
Device: 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.
Other Name: VSail-Access simulator
Experimental: Virtual Sailing
you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks
Intervention: Device: The VSail-Access simulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact: Shannon M Inches 443-923-9235 Inches@kennedykrieger.org
United States
 
 
NCT01491789
NA_00044093
Yes
Not Provided
Not Provided
Albert Recio, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Not Provided
Principal Investigator: Albert Recio, MD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP