An interventional study of Cold pressor test and Exercise under resistance in Analgesia Through Mixed Reality, sponsored by Western University. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Western University · Not applicable, Interventional, and Treatment
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.
Western University is the lead sponsor of 14 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Participants in the traditional rehabilitation group perform self-guided finger range of motion exercises according to a provided guide, without any gaming component.
Other: Cold pressor test · Other: Exercise under resistance
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.
Other: Cold pressor test · Other: Exercise under resistance
Participants submerge their dominant hand in a cold-water bath while performing hand exercises with their non-dominant hand.
Also known as: Cold water submersion test
Participants perform hand exercises against finger extension resistance bands attached to the non-dominant hand.
Also known as: Resistance exercise
Time to cold water withdrawal
The duration (seconds) that participants keep their hand submerged in a cold water bath before voluntarily withdrawing due to discomfort.
Time frame: Assessed continuously during the cold pressor test, from hand immersion until voluntary withdrawal or a maximum of 15 minutes.
Time to fatigue failure
The duration (seconds) that participants continue performing hand exercises against resistance bands before voluntarily stopping due to fatigue.
Time frame: 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
Participant-reported level of hand discomfort immediately following the cold pressor test, measured on a 1-10 numerical rating scale.
Time frame: Assessed immediately following completion of the cold pressor test (within 1 minute of hand withdrawal).
Discomfort Rating After Resisted Exercise
Participant-reported level of hand discomfort immediately following resisted hand exercises, measured on a 1-10 numerical rating scale.
Time frame: Assessed immediately following completion of the resisted exercise task (within 1 minute of exercise cessation).
User experience
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.
Time frame: Assessed once immediately following completion of all study procedures during the single study visit (approximately 45 minutes after intervention initiation).
Plan to share: No — No, individual participant data will not be shared, and is retained and used only by the study team. Use of data is described in detail during the informed consent process, and will be stored securely in accordance with institutional research ethics requirements. Due to our small sample size, there is a risk that participants can be re-identified even after de-identification if IPD is shared.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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