PR-VR At-home Program During and After COVID-19

NCT04912817 | Completed

• 1 other identifier: 1000075493
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Poorly controlled chronic pain in teens can impact quality of life, increase opioid use and is a risk factor for developing chronic pain in adulthood. Currently, there is a shortage of support to help teens manage chronic pain in the community and the support that did exist has been significantly scaled back due to the COVID-19 pandemic. This research study will investigate, based on questionnaires with teens and healthcare providers and interviews with teens, whether pain rehabilitation virtual reality is easy to use and understand, satisfactory to use, and whether it may improve pain, mobility, and function for the teens using the program compared to those doing standard physiotherapy treatment over videoconference.

Conditions

Pain, Chronic

Keywords

paediatric chronic pain; virtual reality; COVID-19

Outcome Measures

Primary Outcomes (8)

• Participant Accrual

  PR-VR Recruitment Log has been designed to measure accrual rates (i.e., record data related to the number of eligible adolescents per recruitment day, reasons for ineligibility, and reasons for non-participation)

  1 year

• Participant Engagement

  PR-VR Activity Log has been designed to measure participant engagement in the study (i.e., record data related to number of completed sessions as well as independent PT exercise sessions participants self-report completing in between clinician-led sessions)

  1 year

• Participant Retention

  PR-VR Activity Log has been designed to measure retention rates (i.e., record data related to reasons for study attrition)

  1 year

• Technical Issues

  PR-VR Intervention Log has been designed to record data related to technical and practical issues (occurrence and description) associated with the PR-VR intervention and implementation of the trial protocol, and time to set up and conduct PR-VR as well as any adverse events (e.g. dizziness, nausea) including the date and time the event occurred and the nature of the event.

  1 year

• Safety of PR-VR Program

  PR-VR Intervention Log has been designed to record data related to any adverse events (e.g. dizziness, nausea) including the date and time the event occurred and the nature of the event.

  1 year

• Time

  PR-VR Intervention Log has been designed to record data related to time to set up

  1 year

• Acceptability/Satisfaction

  Measured using the PR-VR Satisfaction Questionnaire completed by adolescent participants and PTs (using adolescent- and PT-specific versions). This questionnaire will collect data on acceptability and perceived utility of PR-VR intervention. Child questionnaire = Scores range from 1-4 (4-pt likert scale), higher scores indicate greater degree of acceptance (better). PT questionnaire = Scores range from 0-4 (5 pt likert scale), each question has different anchors, so better/worse depends on the question

  1 year

• Outcome measure feasibility

  Will be measured as the percentage of completed outcome measures at baseline and study completion and will be recorded on the PR-VR Distraction Activity Log

  1 year

Secondary Outcomes (11)

• Fear of movement

  Collected at baseline (T1) and 4 weeks from baseline (T2)

• Pain self-efficacy

  Collected at baseline (T1) and 4 weeks from baseline (T2)

• Pain catastrophizing

  Collected at baseline (T1) and 4 weeks from baseline (T2)

• Pain intensity

  Collected at baseline (T1), and immediately post- each PT session verbally to the PT, and 4 weeks from baseline (T2)

• Presence/immersiveness

  Post- each PT session, through study completion, an average of 1 year

Study Arms (3)

Off the Shelf VR (PR-VR program + usual care)

EXPERIMENTAL

* One session per week x 4 weeks; total 4 sessions over 1 month * PR-VR program (30 min) + Usual care (30 min SVPT) * Total intervention time = 4 hours * 10 selected for post-study telephone interview

Other: Off the Shelf VR

Custom VR (Modified PR-VR program + usual care)

EXPERIMENTAL

* One session per week x 4 weeks; total 4 sessions over 1 month * Mod PR-VR program (30 min) + Usual care (30 min SVPT) * Total intervention time = 4 hours * 10 selected for post-study telephone interview

Other: Custom VR

Standard Virtual Physiotherapy Treatment (control; usual care),

NO INTERVENTION

* One session per week x 4 weeks; total 4 sessions over 1 month * Usual care (60 min SVPT) * Total intervention time = 4 hours

Interventions

Off the Shelf VR OTHER

Operates using Oculus quest VR HMD and uses auditory and visual stimuli during the pain rehabilitation treatment. The Off-the-shelf VR program for Oculus Quest VR features a suite of "off-the shelf" applications that can be tailored by the PT and used with participants including. PR-VR sessions will be 30 minutes in total with approximately 20 minutes in the virtual experience and 10 minutes for set-up, screening, instructions, and rest breaks. The Off-the-shelf VR intervention group will also receive 30 minutes of usual care, and Standard Virtual Physiotherapy Treatment (SVPT) during the same appointment, for a total 1-hour usual care session length.

Off the Shelf VR (PR-VR program + usual care)

Custom VR OTHER

Operates using Oculus Quest VR HMD with PR-VR software developed with two gaming options: Fruity Feet and Space Burgers 2. Game settings are manipulated by the physiotherapist in session to target specific limb movements and intensity and also motivates participants to cycle using a leg ergometer. Motion sensors on the ergometer track the participants revolutions per minute. For participants in this study arm, a leg ergometer (DeskCycle) will be provided to them during the study phase alongside the Actigraph and Oculus Quest HMD. During the 30min VR portion of the session, 20 minutes will be dedicated to gaming and exercise, and 10 minutes dedicated for set up, tear down, and rest breaks. During the 20 minutes gaming time, a minimum of 15 minutes will be dedicated to Custom VR, with 5 minutes for 'free play' where the participant can opt to try an off-the-shelf VR game.

Custom VR (Modified PR-VR program + usual care)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• able to speak and read English,
• years old,
• diagnosed with chronic pain,
• under active care at the interprofessional out-patient Chronic Pain Clinic at SickKids,
• on stabilized medication/therapy (no new pain medications/therapies for 1 week prior to the initial PT assessment and treatment) according to medical chart,
• independently mobile and able to safely engage in physical activity,
• requiring a minimum of 4 treatments (1-hour sessions of virtual PT) typically once per week,
• able to have access to an Internet-enabled smartphone, computer or tablet at home (typically once per week for 4 weeks) according to self-report for Zoom for Healthcare visits with PT, and
• willing to have Zoom for Healthcare visits with PT recorded during the study period and, if selected, individual telephone interview with research assistant (RA) audio recorded following the study period.

You may not qualify if:

• visual, auditory or cognitive impairments precluding interaction with the PR-VR intervention and/or control equipment (Internet) as assessed by reviewing the patient's medical chart and consultation with the patient's PT.
• diagnosis of seizure disorder, history of seizure, or increased risk of seizure.
• new onset of headaches/migraines, motion sickness, nausea or vomiting or history/symptoms of possible concussion.
• diagnosis of major, untreated, concurrent psychiatric illness (e.g., depression, anxiety, conversion disorder, PTSD) or personality disorder as assessed by reviewing the patient's medical chart and in consultation by their health care team.
• currently receiving sedating medications
• claustrophobia or previous intolerance of virtual reality (e.g. nausea, vomiting, motion sickness, eye strain, false memory formation) as assessed by health care team.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Stanford University: collaborator

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, m5g 1x8, Canada

Location

MeSH Terms

Conditions

Chronic Pain; COVID-19

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jennifer Stinson, RN, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: A pilot RCT (1:1:1 group allocation) will be used to examine the feasibility of the trial protocol for a definitive trial into the effectiveness of Off-the-shelf VR, Custom VR (Fruity Feet) and Standard Virtual PT (SVPT) in adolescents with chronic pain undergoing functional rehabilitation at home.

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 3, 2021
• Study Start: September 1, 2022
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)