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Active, not recruitingNCT06410794Updated May 13, 2024

Virtual Reality Training in Occupational Rehabilitation

An interventional study of Virtual Reality with Beat Saber in Musculoskeletal Diseases, Mental Health Disorder and Back Pain, Low, sponsored by Molde University College. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2024-05-13.

Sponsored by Molde University College · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 67 Years
Sex
All
01

Study summary

Work-related attention bias modification training and virtual reality training in occupational rehabilitation is a multisite pilot study.

The quantitative aim of this pilot study is to compared virtual reality (VR) training and attention bias modication (ABM) training to investigate whether the different training forms result in different results measured with work-related outcomes and cognitive outcomes. The qualitative aim of this pilot study is to investigate the patients' experiences with the usage of VR.

Three rehabilitation insitutions will be recruiting patients participating in occupational rehabilitation, and the study will compare the outcomes of work-related interventions with and without the addition of ABM or VR training.

The study seeks to determine if these interventions can improve work ability, reduce symptoms of depression and anxiety, and change attentional bias from negative to positive stimuli.

02

Conditions studied

  • Musculoskeletal Diseases
  • Mental Health Disorder
  • Back Pain, Low
  • Anxiety Disorders
  • Depression

Keywords

  • Virtual reality
  • gaming
  • occupational rehabilitation
  • patient experience
  • quanitative study
  • qualitative study
03

Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 18 - 67 years
  • Must be on sick leave, work assessment allowance or on disability pension
  • Receiving work-related rehabilitation or treatment at clinics with either an International Classification of Primary Care, Second edition (ICPC-2) within the musculoskeletal (L), psychiatric (P) or unspecific disorders (A) categories or International Classification Disorders-10 diagnosis within the mental and behavioral disorders (F), Diseases of the musculoskeletal system and connective tissue (M) or other diagnoses.

Exclusion criteria

Exclusion Criteria:

  • Applying for a full disability pension;
  • Unable to complete the measures and receive instructions in Norwegian.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Comparing VR training and ABM training

    The objective of this study is to investigate whether VR and ABM training increases work ability, work-related self-efficacy, attention and reduces symptoms of depression and anxiety and consequently change an attentional bias from negative to positive stimuli. We will compare patients receiving work-related interventions + VR, work-related interventions + ABM training and work-related interventions only. We will also investigate whether positive changes in attentional bias are associated with increased work participation. Self-reported work ability, self-efficacy, depression, anxiety and objective computerised cognitive and emotional testing will be assessed at baseline (start rehabilitation/treatment) and at posttest (end rehabilitation/treatment).

    Device: Virtual Reality with Beat Saber

  • No intervention
    Patients' experiences with the usage of VR.

    The objective of this part is to investigate the experiences in using VR. R\&D personell will make individual interviews with five patients at each of the three clinics involved in piloting VR. The aim of the interviews will be to capture how the patients experienced the VR activity, the demands of the VR activity, how VR has influenced different aspects of health and whether VR has influenced the abilities to return to work.

Interventions

  • DeviceVirtual Reality with Beat Saber

    The VR activity used in the intervention was an add-on activity that did not replace any other activities in the programme. The off-the-shelf product Beat Saber (Beat Games, Prague, The Czech Republic) is the VR game of choice in our study. In collaboration with the participating clinics a systematic VR activity plan will be developed. This includes the selection of games and designing a plan that is interesting and motivating both for patients and clinicians.

05

What researchers measure

Primary outcomes

  1. Increase work ability

    Self-reported questionnaire measures, (Work Ability Scale). Work ability: Self-rated work ability was assessed using a single-item question to determine the WAS; this question was published by Gould et al. as part of the full work ability index (WAI). The question used by this study to measure WAS ("current work ability compared with your lifetime best") used a scale of 0 to 10 (0 = "completely unable to work" and 10 = "work ability at its best"). The following measurement classification from Gould et al. \[46\] was used: poor (0 to 5), moderate (6 to 7), good (8 to 9) and excellent (10).

    Time frame: Baseline and discharge (four weeks), and 6 and 12 months after discharge

  2. Reduced depression and anxiety

    Self-reported questionnaire measure, (The Hospital Anxiety And Depression Scale).

    Time frame: Baseline and discharge (four weeks)

  3. Increase expectations to return to work

    Self-reported questionnaire measures, (Return-to-Work Expectation)

    Time frame: Baseline and discharge (four weeks), and 6 and 12 months after discharge

Secondary outcomes

  1. Increased cognitive performance and attention

    Computerized cognitive measures. - Rapid Visual Information Processing (Cambridge Cognition, 2020). The mean response latency on trials where the subject responded correctly. Calculated across all assessed trials.

    Time frame: Baseline and discharge (four weeks)

  2. Increased cognitive performance and memory

    Computerized cognitive measures. - Spatial Working Memory (Cambridge Cognition, 2020). The number of times the subject incorrectly revisits a box in which a token has previously been found.

    Time frame: Baseline and discharge (four weeks)

  3. Increased cognitive performance

    Computerized cognitive measures. - Stop Signal Task (Cambridge Cognition, 2020). The estimate of time when an individual can successfully inhibit their responses 50% of the time.

    Time frame: Baseline and discharge (four weeks)

  4. Patients's experiences in using VR

    Interview guide based on the participants experience.

    Time frame: From discharge up to 5 month after discharge.

06

Study locations

1 site
  • Norwegian National Advisory Unit on Occupational Rehabilitation
    Rauland, 3864, Norway
07

References and documents

Study documents

  • Protocol and informed consent form · Nov 23, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06410794
Lead sponsor
Molde University College
Collaborators
Norwegian National Advisory Unit on Occupational Rehabilitation
Responsible party
Anita Dyb Linge (Research and Developement Manager, Molde University College) — Principal investigator
First posted
May 13, 2024
Start date
Jan 1, 2022
Primary completion
Jan 1, 2026 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
May 13, 2024

Study contacts

Chris Jensen, PhD
study director · Norwegian National Advisory Unit on Occupational Rehabilitation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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