Trial Outcomes & Findings for Virtual Sailing Simulator in Individuals With Spinal Cord Injury (NCT NCT01491789)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Baseline

Results posted on

2024-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Sailing you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks 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.
Overall Study STARTED	18
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Sailing n=17 Participants you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks 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.
Age, Categorical <=18 years	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=17 Participants
Age, Categorical >=65 years	0 Participants n=17 Participants
Age, Continuous	45 years n=17 Participants
Sex: Female, Male Female	7 Participants n=17 Participants
Sex: Female, Male Male	10 Participants n=17 Participants
Region of Enrollment United States	17 participants n=17 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Scale of 0-100, higher values represent better outcome

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.

Outcome measures

Outcome measures
Measure	Virtual Sailing n=10 Participants you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks 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.
Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23	48.2 score on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Baseline

Population: score on a scale of 0-30 higher values represent better outcome

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

Outcome measures

Outcome measures
Measure	Virtual Sailing n=13 Participants you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks 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.
Functional Reach Test, Level of Trunk Activation Test	13.4 units on a scale Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: Baseline

Population: score on a scale from 0-200 higher values represent better outcome

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.

Outcome measures

Outcome measures
Measure	Virtual Sailing n=13 Participants you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks 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.
Grasp/Pinch Test	55 units on a scale Interval 0.0 to 200.0

SECONDARY outcome

Timeframe: Baseline

Population: higher values represent better outcome

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.

Outcome measures

Outcome measures
Measure	Virtual Sailing n=13 Participants you will be doing 60 minutes of Virtual Sailing training, 1 time a week for 12 weeks 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.
Sailing Ability Questionnaire	1 units on a scale Interval 0.0 to 1.0

Adverse Events

Virtual Sailing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alberrt Recio

Kennedy Krieger Institute

Phone: 443-923-9227

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place