Virtual Reality-based Rehabilitation for Traumatic Hand and Wrist Injuries (AOT-VR-HAND)
2 juin 2026 mis à jour par: Atenea Villalobos-García, University of Malaga
Use of Virtual Reality to Improve Sensorimotor Function in Patients With Traumatic Wrist and Hand Injuries
This randomized controlled trial aims to evaluate the effectiveness of immersive virtual reality (VR)-based Action Observation Therapy (AOT) as an adjunct to conventional rehabilitation in patients with traumatic wrist and hand injuries.
Participants will receive standard rehabilitation treatment, and the intervention group will additionally undergo a six-week VR program involving observation and execution of functional hand and wrist movements.
Outcomes related to hand function, grip strength, pain, proprioception, disability, and psychological factors will be assessed to determine the potential benefits of incorporating VR into rehabilitation programs.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
Traumatic injuries of the wrist and hand are among the most common musculoskeletal conditions and can result in substantial impairments in function, strength, dexterity, and quality of life. Conventional rehabilitation is effective but often relies on repetitive exercises that may reduce patient motivation and adherence over time.
Virtual reality (VR) has emerged as a promising rehabilitation tool by providing immersive, interactive, and task-oriented environments that enhance patient engagement and facilitate motor learning. In addition, Action Observation Therapy (AOT) is based on the activation of the mirror neuron system, whereby observing goal-directed movements may facilitate motor planning, cortical reorganization, and functional recovery.
The present randomized controlled trial will investigate the effectiveness of immersive VR-based AOT as a complementary intervention to conventional rehabilitation in patients with traumatic wrist and hand injuries. Participants receiving treatment at a specialized hand therapy unit will be randomly assigned to rehabilitation programs that include immersive VR sessions in addition to standard care.
The VR intervention will be delivered using Meta Quest Pro head-mounted displays and will consist of observation and subsequent execution of functional wrist and hand movements, including grasping, releasing, fine motor tasks, flexion-extension, and deviation movements. The intervention will be conducted twice weekly for six weeks, with approximately 45-minute sessions.
Outcome measures will include grip strength, pain, wrist function, upper-limb disability, proprioception, kinesiophobia, pain catastrophizing, and patient-reported hand function. Assessments will be performed using validated clinical instruments, including the Jamar dynamometer, Patient-Rated Wrist Evaluation (PRWE), Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), Tampa Scale of Kinesiophobia (TSK-11), Pain Catastrophizing Scale (PCS), Joint Position Sense (JPS), and Michigan Hand Outcomes Questionnaire (MHQ).
The study aims to determine whether the addition of immersive VR-based AOT to conventional rehabilitation improves sensorimotor recovery, functional outcomes, and patient engagement following traumatic wrist and hand injuries.
Type d'étude
Interventionnel
Inscription (Estimé)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Málaga, Espagne, 29071
- Recrutement
- UMA
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Contact:
- Atenea Villalobos-García, Occupational therapist
- Numéro de téléphone: 34 635840829
- E-mail: atevillagar@uma.es
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Adults aged 18 years or older.
- Diagnosis of a traumatic wrist and/or hand injury.
- Referred for rehabilitation treatment at the participating hand therapy unit.
- Ability to understand study procedures and provide written informed consent.
- Ability to participate in the virtual reality intervention.
Exclusion Criteria:
- Previous injury affecting the same hand.
- Associated upper-limb conditions, including tenosynovitis or Dupuytren's disease.
- Previous surgery involving the affected hand before the current traumatic injury.
- Corticosteroid or other therapeutic injection in the affected hand within the previous 3 weeks.
- Any physical, neurological, visual, vestibular, or medical condition that prevents safe use of the virtual reality device.
- Inability to comply with the study procedures or assessments.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: RV Group
Patients will receive conventional rehabilitation for traumatic wrist and hand injuries in addition to immersive virtual reality-based Action Observation Therapy (AOT).
The virtual reality intervention consists of observation and execution of functional wrist and hand movements using a head-mounted display, delivered twice weekly for six weeks.
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Participants observe and subsequently perform functional wrist and hand movements within immersive virtual reality environments using a Meta Quest Pro headset.
The intervention is delivered twice weekly for six weeks, with sessions lasting approximately 45 minutes.
Autres noms:
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Comparateur actif: Hand Therapy Group
Patients will receive conventional rehabilitation including active and passive mobilization, progressive strengthening exercises, functional re-education, and pain management according to the stage of recovery.
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Standard rehabilitation program for traumatic wrist and hand injuries including active and passive mobilization, strengthening exercises, functional training, and pain management.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Délai: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention
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Self-reported upper limb disability assessed with QuickDASH questionnaire (0-100, higher scores indicate greater disability).
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Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention
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Patient-Rated Wrist and Hand Evaluation (PRWHE) Total Score
Délai: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Wrist and hand pain and function assessed with the PRWHE questionnaire (0-100, lower scores indicate better outcomes).
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Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Michigan Hand Outcomes Questionnaire (MHQ) Total Score
Délai: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Hand-specific function, pain, activities of daily living, work performance, aesthetics and satisfaction assessed with the MHQ (0-100 scale).
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Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Shoulder Pain and Disability Index (SPADI) Total Score
Délai: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Shoulder pain and disability assessed with SPADI questionnaire (0-100, lower scores indicate better outcomes).
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Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Pain Catastrophizing scale (PCS) Total Score
Délai: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Maladaptive pain-related cognitions assessed with the PCS (0-52, higher scores indicate greater catastrophizing).
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Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Tampa Scale for Kinesiophobia (TSK-11) Total Score
Délai: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Fear of movement assessed with the TSK-11 questionnaire (11-44, higher scores indicate greater kinesiophobia).
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Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Active Wrist range of motion (degrees)
Délai: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Active wrist flexion, extension, radial deviation, ulnar deviation, pronation and supination measured with a universal goniometer (degrees).
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Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Grip strength (Kg)
Délai: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Grip strength measured in kilograms using a Jamar dynamometer in standardized position.
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Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Wrist joint position sense error (Degrees)
Délai: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Proprioceptive accuracy assessed as the mean absolute angular error (degrees) between a target wrist joint position set by the examiner and the position actively reproduced by the participant with eyes closed.
Lower values indicate better proprioceptive accuracy.
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Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of virtual reality - related adverse events
Délai: From firsts intervention session through final intervention session (approximately 6 weeks).
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Number of participants experiencing dizziness, nausea, visual discomfort, or disorientation during intervention sessions.
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From firsts intervention session through final intervention session (approximately 6 weeks).
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Intervention adherence
Délai: From firsts intervention session through final intervention session (approximately 6 weeks).
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Percentage of prescribed sessions completed by each participant.
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From firsts intervention session through final intervention session (approximately 6 weeks).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 février 2026
Achèvement primaire (Estimé)
30 septembre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
2 juin 2026
Première soumission répondant aux critères de contrôle qualité
2 juin 2026
Première publication (Réel)
8 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UMA-VR-HAND-2026-003
- CEUMA 24-2025-H (Identificateur de registre: CEUMA: 24-2025-H)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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