Telehealth Virtual Reality Exergaming for Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Telehealth Virtual Reality Exergaming and Peer Networking Among People With Spinal Cord Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05318079
• Other study ID #: IRB-300008605
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: April 13, 2022

Study information

• Verified date: April 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 13, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Virtual Reality Gaming
Peer-to-peer gaming.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total play time	Percentage of the 300 minutes of prescribed play per week across the intervention.	Intervention Week 1 - Week 8
Primary	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).	Intervention Week 1 - Week 8
Primary	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).	Intervention Week 1 - Week 8
Primary	Compliance to baseline data collection	Number of pre data collections completed, converted into a percentage dividing by the total possible.	Week 0
Primary	Compliance to post data collections	Number of pre data collections completed, converted into a percentage dividing by the total possible.	Week 9
Secondary	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.	Week 0, Week 5, Week 9
Secondary	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.	Week 0, Week 5, Week 9
Secondary	Functional Grip Strength	Grip strength will be measured as an indicator of global muscular strength, using a low-cost hand-held dynamometer.	Week 0, Week 5, Week 9
Secondary	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.	Intervention Week 9
Secondary	Changes in blood pressure	Changes in resting home-blood pressure (systolic and diastolic ) measured via blood pressure cuff across the intervention.	Week 0, Week 5, Week 9
Secondary	Changes in high sensitivity C-reactive protein (hsCRP)	Changes in high sensitivity C-reactive protein measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Secondary	Changes in hemoglobin A1c	Changes in hemoglobin A1c measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Secondary	Changes in fasting insulin	Changes in fasting insulin levels measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Secondary	Changes in fasting triglycerides	Changes in fasting triglycerides levels measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Secondary	Changes in total cholesterol	Changes in total cholesterol measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Secondary	Changes in low-density lipoprotein (LDL)	Changes in low-density lipoprotein via blood spot test across the intervention.	Week 0, Week 5, Week 9
Secondary	Changes in high-density lipoprotein (LDL)	Changes in high-density lipoprotein via blood spot test across the intervention.	Week 0, Week 5, Week 9