NCT01491789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 9, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

11.3 years

First QC Date

December 6, 2011

Results QC Date

August 28, 2023

Last Update Submit

December 19, 2023

Conditions

Spinal Cord Injury

Keywords

spinal cord injuryVirtual sailingVsail

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (3)

  • Functional Reach Test, Level of Trunk Activation Test

    Baseline

  • Grasp/Pinch Test

    Baseline

  • Sailing Ability Questionnaire

    Baseline

Study Arms (1)

Virtual Sailing

EXPERIMENTAL

you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks

Device: The VSail-Access simulator

Interventions

The VSail-Access simulatorDEVICE

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.

Also known as: VSail-Access simulator
Virtual Sailing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. Alberrt Recio
Organization
Kennedy Krieger Institute
recio@kennedykrieger.org
443-923-9227

Study Officials

  • Albert Recio, MD

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty, Physician

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 14, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

January 9, 2024

Results First Posted

January 9, 2024

Record last verified: 2023-12

Locations

US(1)