Spinal Cord InjuriesNCT05318079
Telehealth Virtual Reality Exergaming for Spinal Cord Injury
A study testing Virtual Reality Gaming in people with Spinal Cord Injuries, run by University of Alabama at Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Virtual Reality Gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 13 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Telehealth Virtual Reality Exergaming and Peer Networking Among People With Spinal Cord Injury
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Virtual Reality Gaming
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GamingBehavioural
Peer-to-peer gaming.
| Study group | Role | What they receive |
|---|---|---|
| Group virtual reality gaming | Experimental | 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. Receives: Behavioral: Virtual Reality Gaming |
| Wait-list Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total play time
Percentage of the 300 minutes of prescribed play per week across the intervention.
Measured: Intervention Week 1 - Week 8
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).
Measured: Intervention Week 1 - Week 8
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).
Measured: Intervention Week 1 - Week 8
Compliance to baseline data collection
Number of pre data collections completed, converted into a percentage dividing by the total possible.
Measured: Week 0
Compliance to post data collections
Number of pre data collections completed, converted into a percentage dividing by the total possible.
Measured: Week 9
Secondary outcomes (12)
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.
Measured: Week 0, Week 5, Week 9
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.
Measured: Week 0, Week 5, Week 9
Functional Grip Strength
Grip strength will be measured as an indicator of global muscular strength, using a low-cost hand-held dynamometer.
Measured: Week 0, Week 5, Week 9
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.
Measured: Intervention Week 9
Changes in blood pressure
Changes in resting home-blood pressure (systolic and diastolic ) measured via blood pressure cuff across the intervention.
Measured: Week 0, Week 5, Week 9
Changes in high sensitivity C-reactive protein (hsCRP)
Changes in high sensitivity C-reactive protein measured via blood spot test across the intervention.
Measured: Week 0, Week 5, Week 9
Changes in hemoglobin A1c
Changes in hemoglobin A1c measured via blood spot test across the intervention.
Measured: Week 0, Week 5, Week 9
Changes in fasting insulin
Changes in fasting insulin levels measured via blood spot test across the intervention.
Measured: Week 0, Week 5, Week 9
Changes in fasting triglycerides
Changes in fasting triglycerides levels measured via blood spot test across the intervention.
Measured: Week 0, Week 5, Week 9
Changes in total cholesterol
Changes in total cholesterol measured via blood spot test across the intervention.
Measured: Week 0, Week 5, Week 9
Changes in low-density lipoprotein (LDL)
Changes in low-density lipoprotein via blood spot test across the intervention.
Measured: Week 0, Week 5, Week 9
Changes in high-density lipoprotein (LDL)
Changes in high-density lipoprotein via blood spot test across the intervention.
Measured: Week 0, Week 5, Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion12 Apr 2022
- Study completion13 Apr 2022
Why it stopped: The study was not selected for funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron Lai, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318079
- Sponsor's protocol ID
- IRB-300008605
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Virtual Reality Exergaming and Peer Networking Among People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05318079
- Acronym / sponsor ID
- IRB-300008605
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not selected for funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group virtual reality gaming | Experimental | Behavioral: Virtual Reality GamingThe 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. |
| Wait-list Control | No intervention | –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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality GamingPeer-to-peer gaming. | Behavioural | Group virtual reality gaming |
Primary outcome
Total play time
Time frame: Intervention Week 1 - Week 8
Percentage of the 300 minutes of prescribed play per week across the intervention.
Total exercise time
Time frame: Intervention Week 1 - Week 8
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
Time frame: Intervention Week 1 - Week 8
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
Time frame: Week 0
Number of pre data collections completed, converted into a percentage dividing by the total possible.
Compliance to post data collections
Time frame: Week 9
Number of pre data collections completed, converted into a percentage dividing by the total possible.
12 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Week 0, Week 5, Week 9
World Health Organization Quality of Life
Time frame: Week 0, Week 5, Week 9
Functional Grip Strength
Time frame: Week 0, Week 5, Week 9
Critical factors that affected adherence
Time frame: Intervention Week 9
Changes in blood pressure
Time frame: Week 0, Week 5, Week 9
Changes in high sensitivity C-reactive protein (hsCRP)
Time frame: Week 0, Week 5, Week 9
Changes in hemoglobin A1c
Time frame: Week 0, Week 5, Week 9
Changes in fasting insulin
Time frame: Week 0, Week 5, Week 9
Changes in fasting triglycerides
Time frame: Week 0, Week 5, Week 9
Changes in total cholesterol
Time frame: Week 0, Week 5, Week 9
Changes in low-density lipoprotein (LDL)
Time frame: Week 0, Week 5, Week 9
Changes in high-density lipoprotein (LDL)
Time frame: Week 0, Week 5, Week 9
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Gaming in people with Spinal Cord Injuries, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total play time (time frame: Intervention Week 1 - Week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.