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Telehealth Virtual Reality Exergaming for Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Gaming
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • medical diagnosis of traumatic spinal cord injury (determined by International Classification of Disease [ICD] codes)
  • a caregiver to support the participant if the participant is a child (<18 years of age)
  • access to a Wi-Fi Internet connection in the home

Exclusion Criteria:

  • physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
  • cannot use the arms for exercise or operate the controller buttons using their fingers
  • complete blindness or deafness
  • recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension [BP >/= 180/110 mmHg]
  • prone to seizures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group virtual reality gaming

    Wait-list Control

    Arm Description

    The intervention will include home-based exercise using the Oculus Quest 2. Participants will be prescribed two gaming goals to achieve across the 8-week intervention. The first goal will be to play with the Quest for at least ≥60 minutes, 5 days per week (Monday - Friday) across the 8-week intervention: a total of 300 minutes. Participants can achieve these goals through either single- or multiplayer gaming but will be prescribed to engage in online multiplayer or peer-to-peer gaming at least 2 days per week.

    People who are randomized to the waitlist group will undergo 4-weeks of wait (habitual daily activities), followed by 8-weeks of VR intervention. People in the wait-group will be in the study for a total of 12 weeks.

    Outcomes

    Primary Outcome Measures

    Total play time
    Percentage of the 300 minutes of prescribed play per week across the intervention.
    Total exercise time
    Moderate exercise minutes where prescription was met (percent of prescription achieved: weeks where the ≥90 minutes of moderate intensity exercise per week was achieved across the intervention, divided by total weeks).
    Playtime with others
    Measured by the number of play sessions with other players (online multiplayer and/or peer-gaming). This number will be totaled across the 8-week intervention and divided by 16 (the exercise prescription of 2 x per week of multiplayer gaming).
    Compliance to baseline data collection
    Number of pre data collections completed, converted into a percentage dividing by the total possible.
    Compliance to post data collections
    Number of pre data collections completed, converted into a percentage dividing by the total possible.

    Secondary Outcome Measures

    Hospital Anxiety and Depression Scale
    The Hospital Anxiety and Depression Scale is a 14-item self-report measure that provides separate scores for anxiety and depression. Hospital Anxiety and Depression Scale is a common clinical measure that has strong psychometric properties. Scores range from 0 to 42, where a higher score represents a worse level of depression.
    World Health Organization Quality of Life
    The World Health Organization Quality of Life is a self-report questionnaire with 26 items that cover 5 dimensions: physical health (7 items); psychological health (6 items); social relationships (3 items); environment (8 items); and overall quality of life (2 items). Raw scores are calculated for each domain on a lilkert scale of 1-5 (low domain score of 3, max domain raw score of 40. Raw scores are then multiplied by 4 to transform the raw score into a scaled score. Higher scores represent higher perceived ratings of quality of life.
    Functional Grip Strength
    Grip strength will be measured as an indicator of global muscular strength, using a low-cost hand-held dynamometer.
    Critical factors that affected adherence
    Participants will undergo one-on-one, semi-structured interviews after the intervention to identify critical factors that affected their participation to the intervention.
    Changes in blood pressure
    Changes in resting home-blood pressure (systolic and diastolic ) measured via blood pressure cuff across the intervention.
    Changes in high sensitivity C-reactive protein (hsCRP)
    Changes in high sensitivity C-reactive protein measured via blood spot test across the intervention.
    Changes in hemoglobin A1c
    Changes in hemoglobin A1c measured via blood spot test across the intervention.
    Changes in fasting insulin
    Changes in fasting insulin levels measured via blood spot test across the intervention.
    Changes in fasting triglycerides
    Changes in fasting triglycerides levels measured via blood spot test across the intervention.
    Changes in total cholesterol
    Changes in total cholesterol measured via blood spot test across the intervention.
    Changes in low-density lipoprotein (LDL)
    Changes in low-density lipoprotein via blood spot test across the intervention.
    Changes in high-density lipoprotein (LDL)
    Changes in high-density lipoprotein via blood spot test across the intervention.

    Full Information

    First Posted
    March 22, 2022
    Last Updated
    April 13, 2022
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05318079
    Brief Title
    Telehealth Virtual Reality Exergaming for Spinal Cord Injury
    Official Title
    Telehealth Virtual Reality Exergaming and Peer Networking Among People With Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was not selected for funding.
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    April 12, 2022 (Actual)
    Study Completion Date
    April 13, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This pilot feasibility study aims to test whether youth and adults with spinal cord injury can use a group virtual reality gaming intervention to exercise. A second purpose is to examine whether there are potential benefits to cardiometabolic health and psychosocial health.
    Detailed Description
    There are three purposes to this study. The first purpose is to quantify feasibility through telemonitored exercise data: total play time, moderate exercise time, playtime with others, and compliance to the data collections. These variables will be compared against a priori criteria for acceptability. These variables will help determine whether modifications to the intervention protocol are necessary. The second purpose is to qualitatively interview participants to explain underlying behavioral mechanisms that affect their participation in the program. This information will be used to explain how to improve implementation issues identified in Aim 1. The third aim is to explore the potential effects of the program on self-reported psychosocial health and quality of life, hand-grip strength, and cardiometabolic health (blood cholesterol, lipids, pressure, and insulin) measured via home dried blood spot test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group virtual reality gaming
    Arm Type
    Experimental
    Arm Description
    The intervention will include home-based exercise using the Oculus Quest 2. Participants will be prescribed two gaming goals to achieve across the 8-week intervention. The first goal will be to play with the Quest for at least ≥60 minutes, 5 days per week (Monday - Friday) across the 8-week intervention: a total of 300 minutes. Participants can achieve these goals through either single- or multiplayer gaming but will be prescribed to engage in online multiplayer or peer-to-peer gaming at least 2 days per week.
    Arm Title
    Wait-list Control
    Arm Type
    No Intervention
    Arm Description
    People who are randomized to the waitlist group will undergo 4-weeks of wait (habitual daily activities), followed by 8-weeks of VR intervention. People in the wait-group will be in the study for a total of 12 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual Reality Gaming
    Intervention Description
    Peer-to-peer gaming.
    Primary Outcome Measure Information:
    Title
    Total play time
    Description
    Percentage of the 300 minutes of prescribed play per week across the intervention.
    Time Frame
    Intervention Week 1 - Week 8
    Title
    Total exercise time
    Description
    Moderate exercise minutes where prescription was met (percent of prescription achieved: weeks where the ≥90 minutes of moderate intensity exercise per week was achieved across the intervention, divided by total weeks).
    Time Frame
    Intervention Week 1 - Week 8
    Title
    Playtime with others
    Description
    Measured by the number of play sessions with other players (online multiplayer and/or peer-gaming). This number will be totaled across the 8-week intervention and divided by 16 (the exercise prescription of 2 x per week of multiplayer gaming).
    Time Frame
    Intervention Week 1 - Week 8
    Title
    Compliance to baseline data collection
    Description
    Number of pre data collections completed, converted into a percentage dividing by the total possible.
    Time Frame
    Week 0
    Title
    Compliance to post data collections
    Description
    Number of pre data collections completed, converted into a percentage dividing by the total possible.
    Time Frame
    Week 9
    Secondary Outcome Measure Information:
    Title
    Hospital Anxiety and Depression Scale
    Description
    The Hospital Anxiety and Depression Scale is a 14-item self-report measure that provides separate scores for anxiety and depression. Hospital Anxiety and Depression Scale is a common clinical measure that has strong psychometric properties. Scores range from 0 to 42, where a higher score represents a worse level of depression.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    World Health Organization Quality of Life
    Description
    The World Health Organization Quality of Life is a self-report questionnaire with 26 items that cover 5 dimensions: physical health (7 items); psychological health (6 items); social relationships (3 items); environment (8 items); and overall quality of life (2 items). Raw scores are calculated for each domain on a lilkert scale of 1-5 (low domain score of 3, max domain raw score of 40. Raw scores are then multiplied by 4 to transform the raw score into a scaled score. Higher scores represent higher perceived ratings of quality of life.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    Functional Grip Strength
    Description
    Grip strength will be measured as an indicator of global muscular strength, using a low-cost hand-held dynamometer.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    Critical factors that affected adherence
    Description
    Participants will undergo one-on-one, semi-structured interviews after the intervention to identify critical factors that affected their participation to the intervention.
    Time Frame
    Intervention Week 9
    Title
    Changes in blood pressure
    Description
    Changes in resting home-blood pressure (systolic and diastolic ) measured via blood pressure cuff across the intervention.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    Changes in high sensitivity C-reactive protein (hsCRP)
    Description
    Changes in high sensitivity C-reactive protein measured via blood spot test across the intervention.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    Changes in hemoglobin A1c
    Description
    Changes in hemoglobin A1c measured via blood spot test across the intervention.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    Changes in fasting insulin
    Description
    Changes in fasting insulin levels measured via blood spot test across the intervention.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    Changes in fasting triglycerides
    Description
    Changes in fasting triglycerides levels measured via blood spot test across the intervention.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    Changes in total cholesterol
    Description
    Changes in total cholesterol measured via blood spot test across the intervention.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    Changes in low-density lipoprotein (LDL)
    Description
    Changes in low-density lipoprotein via blood spot test across the intervention.
    Time Frame
    Week 0, Week 5, Week 9
    Title
    Changes in high-density lipoprotein (LDL)
    Description
    Changes in high-density lipoprotein via blood spot test across the intervention.
    Time Frame
    Week 0, Week 5, Week 9

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: medical diagnosis of traumatic spinal cord injury (determined by International Classification of Disease [ICD] codes) a caregiver to support the participant if the participant is a child (<18 years of age) access to a Wi-Fi Internet connection in the home Exclusion Criteria: physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week) cannot use the arms for exercise or operate the controller buttons using their fingers complete blindness or deafness recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension [BP >/= 180/110 mmHg] prone to seizures

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Telehealth Virtual Reality Exergaming for Spinal Cord Injury

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