- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Ontario
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London, Ontario, Canada, N6A 3K7
- University of Western Ontario
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
Autres noms:
Participants perform hand exercises against finger extension resistance bands attached to the non-dominant hand.
Autres noms:
|
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Expérimental: 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.
Autres noms:
Participants perform hand exercises against finger extension resistance bands attached to the non-dominant hand.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to cold water withdrawal
Délai: Assessed continuously during the cold pressor test, from hand immersion until voluntary withdrawal or a maximum of 15 minutes.
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The duration (seconds) that participants keep their hand submerged in a cold water bath before voluntarily withdrawing due to discomfort.
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Assessed continuously during the cold pressor test, from hand immersion until voluntary withdrawal or a maximum of 15 minutes.
|
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Time to fatigue failure
Délai: Assessed continuously during resisted hand exercise, from exercise initiation until voluntary cessation due to fatigue or a maximum of 15 minutes.
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The duration (seconds) that participants continue performing hand exercises against resistance bands before voluntarily stopping due to fatigue.
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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
Délai: Assessed immediately following completion of the cold pressor test (within 1 minute of hand withdrawal).
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Participant-reported level of hand discomfort immediately following the cold pressor test, measured on a 1-10 numerical rating scale.
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Assessed immediately following completion of the cold pressor test (within 1 minute of hand withdrawal).
|
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Discomfort Rating After Resisted Exercise
Délai: Assessed immediately following completion of the resisted exercise task (within 1 minute of exercise cessation).
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Participant-reported level of hand discomfort immediately following resisted hand exercises, measured on a 1-10 numerical rating scale.
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Assessed immediately following completion of the resisted exercise task (within 1 minute of exercise cessation).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
User experience
Délai: Assessed once immediately following completion of all study procedures during the single study visit (approximately 45 minutes after intervention initiation).
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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.
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Assessed once immediately following completion of all study procedures during the single study visit (approximately 45 minutes after intervention initiation).
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Activité motrice
- Mouvement
- Phénomènes physiologiques musculo-squelettiques
- Phénomènes physiologiques musculo-squelettiques et neuronaux
- Thérapeutique
- Modalités de physiothérapie
- Soins aux patients
- Thérapie d'exercice
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Conditionnement physique, humain
- Exercice
- Formation en résistance
Autres numéros d'identification d'étude
- 128579
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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