- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07668115
Gamifying Hand Therapy: Development of a Mixed Reality Rhythm Game to Reduce Pain and Improve Motivation
The hand is one of the most functional and frequently injured parts of the body. Without proper recovery, patients can face significant impairments performing everyday tasks. Hand therapy is the cornerstone of hand rehabilitation, but the painful, repetitive, and monotonous nature of prescribed exercises leads to poor patient motivation and adherence, ultimately compromising long-term recovery outcomes.
New technologies such as virtual reality (VR) and augmented reality (AR) have emerged as interactive and engaging modalities for rehabilitation, and can even reduce pain by distracting patients during exercises. However, mixed reality (MR), which is a new modality combining VR and AR has not been well studied for its ability to reduce pain in hand rehabilitation. Therefore, we developed HoloRehab, a mixed reality video game for hand rehabilitation, built for the Microsoft HoloLens 2 headset. This device allow users to see and interact with realistic 3D holograms projected into their physical environment.
This pilot study will evaluate whether using HoloRehab can reduce discomfort and improve the exercise experience compared to traditional self-guided hand therapy exercises. After development of a prototyped game, we will run a pilot study involving 20 healthy participants assigned to either the mixed reality intervention or a traditional exercise group. Outcomes will include measures of discomfort, fatigue, and user experience.
Findings from this study will inform further development of the HoloRehab system.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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London, Ontario, Canada, N6A 3K7
- University of Western Ontario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult (≥18 years old) medical students at Western University
- English-speaking
- No existing hand pathology
- Able and willing to provide informed consent
Exclusion Criteria:
- Musculoskeletal conditions
- Neurological conditions
- Chronic pain conditions
- Previous hand surgeries
- Function-altering hand injuries
- History of motion sickness
- History of seizures or epilepsy
- Cold sensitivity or cold intolerance
- Current use of analgesic medications (e.g., NSAIDs, acetaminophen, opioids)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional Rehabilitation
Participants in the traditional rehabilitation group perform self-guided finger range of motion exercises according to a provided guide, without any gaming component.
|
Participants submerge their dominant hand in a cold-water bath while performing hand exercises with their non-dominant hand.
Other Names:
Participants perform hand exercises against finger extension resistance bands attached to the non-dominant hand.
Other Names:
|
|
Experimental: HoloRehab Gaming Rehablitation
Participants in the HoloRehab Gaming Rehabilitation group perform the same finger range of motion exercises compared to traditional rehabilitation group, but through the medium of an extended reality rhythm video game with Microsoft HoloLens 3.
|
Participants submerge their dominant hand in a cold-water bath while performing hand exercises with their non-dominant hand.
Other Names:
Participants perform hand exercises against finger extension resistance bands attached to the non-dominant hand.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to cold water withdrawal
Time Frame: Assessed continuously during the cold pressor test, from hand immersion until voluntary withdrawal or a maximum of 15 minutes.
|
The duration (seconds) that participants keep their hand submerged in a cold water bath before voluntarily withdrawing due to discomfort.
|
Assessed continuously during the cold pressor test, from hand immersion until voluntary withdrawal or a maximum of 15 minutes.
|
|
Time to fatigue failure
Time Frame: Assessed continuously during resisted hand exercise, from exercise initiation until voluntary cessation due to fatigue or a maximum of 15 minutes.
|
The duration (seconds) that participants continue performing hand exercises against resistance bands before voluntarily stopping due to fatigue.
|
Assessed continuously during resisted hand exercise, from exercise initiation until voluntary cessation due to fatigue or a maximum of 15 minutes.
|
|
Discomfort Rating After Cold Water Withdraw
Time Frame: Assessed immediately following completion of the cold pressor test (within 1 minute of hand withdrawal).
|
Participant-reported level of hand discomfort immediately following the cold pressor test, measured on a 1-10 numerical rating scale.
|
Assessed immediately following completion of the cold pressor test (within 1 minute of hand withdrawal).
|
|
Discomfort Rating After Resisted Exercise
Time Frame: Assessed immediately following completion of the resisted exercise task (within 1 minute of exercise cessation).
|
Participant-reported level of hand discomfort immediately following resisted hand exercises, measured on a 1-10 numerical rating scale.
|
Assessed immediately following completion of the resisted exercise task (within 1 minute of exercise cessation).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User experience
Time Frame: Assessed once immediately following completion of all study procedures during the single study visit (approximately 45 minutes after intervention initiation).
|
Participant-reported overall satisfaction, usability, comfort, enjoyment, and perceived effectiveness of the assigned exercise modality, assessed using a post-intervention questionnaire consisting of Likert-scale items.
For participants in the intervention arm, this includes experience with the HoloRehab game and the HoloLens 2 headset.
|
Assessed once immediately following completion of all study procedures during the single study visit (approximately 45 minutes after intervention initiation).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Wolf S, Hardy JD. STUDIES ON PAIN. OBSERVATIONS ON PAIN DUE TO LOCAL COOLING AND ON FACTORS INVOLVED IN THE "COLD PRESSOR" EFFECT. J Clin Invest. 1941 Sep;20(5):521-33. doi: 10.1172/JCI101245. No abstract available.
- Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5.
- Ali RR, Selim AO, Abdel Ghafar MA, Abdelraouf OR, Ali OI. Virtual reality as a pain distractor during physical rehabilitation in pediatric burns. Burns. 2022 Mar;48(2):303-308. doi: 10.1016/j.burns.2021.04.031. Epub 2021 May 5.
- Neiman NR, Falkson SR, Rodriguez ST, Wang EY, Hemphill SF, Khoury ME, Kist MN, Jackson CD, Caruso TJ. Quantifying virtual reality pain modulation in healthy volunteers: A randomized, crossover study. J Clin Anesth. 2022 Sep;80:110876. doi: 10.1016/j.jclinane.2022.110876. Epub 2022 May 4.
- Moreau S, Therond A, Cerda IH, Studer K, Pan A, Tharpe J, Crowther JE, Abd-Elsayed A, Gilligan C, Tolba R, Ashina S, Schatman ME, Kaye AD, Yong RJ, Robinson CL. Virtual Reality in Acute and Chronic Pain Medicine: An Updated Review. Curr Pain Headache Rep. 2024 Sep;28(9):893-928. doi: 10.1007/s11916-024-01246-2. Epub 2024 Apr 8.
- Birnie KA, Noel M, Chambers CT, von Baeyer CL, Fernandez CV. The cold pressor task: is it an ethically acceptable pain research method in children? J Pediatr Psychol. 2011 Nov-Dec;36(10):1071-81. doi: 10.1093/jpepsy/jsq092. Epub 2010 Oct 5.
- Pereira MF, Prahm C, Kolbenschlag J, Oliveira E, Rodrigues NF. Application of AR and VR in hand rehabilitation: A systematic review. J Biomed Inform. 2020 Nov;111:103584. doi: 10.1016/j.jbi.2020.103584. Epub 2020 Oct 2.
- Zhang C, Yu S. The Technology to Enhance Patient Motivation in Virtual Reality Rehabilitation: A Review. Games Health J. 2024 Aug;13(4):215-233. doi: 10.1089/g4h.2023.0069.
- Khamees KM, Deldar K, Yazarlu O, Tuama AM, Ganji R, Mazlom SR, Froutan R. Effect of augmented reality-based rehabilitation of hand burns on hand function in children: A randomized controlled trial. J Hand Ther. 2025 Apr-Jun;38(2):235-245. doi: 10.1016/j.jht.2023.10.009. Epub 2024 Feb 12.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 128579
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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