Virtual Reality-based Rehabilitation for Traumatic Hand and Wrist Injuries (AOT-VR-HAND)
2026. június 2. frissítette: 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.
A tanulmány áttekintése
Állapot
Toborzás
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
40
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
-
-
Málaga, Spanyolország, 29071
- Toborzás
- UMA
-
Kapcsolatba lépni:
- Atenea Villalobos-García, Occupational therapist
- Telefonszám: 34 635840829
- E-mail: atevillagar@uma.es
-
-
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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.
|
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.
Más nevek:
|
|
Aktív összehasonlító: 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.
|
Standard rehabilitation program for traumatic wrist and hand injuries including active and passive mobilization, strengthening exercises, functional training, and pain management.
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Időkeret: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention
|
Self-reported upper limb disability assessed with QuickDASH questionnaire (0-100, higher scores indicate greater disability).
|
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention
|
|
Patient-Rated Wrist and Hand Evaluation (PRWHE) Total Score
Időkeret: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Wrist and hand pain and function assessed with the PRWHE questionnaire (0-100, lower scores indicate better outcomes).
|
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
|
Michigan Hand Outcomes Questionnaire (MHQ) Total Score
Időkeret: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Hand-specific function, pain, activities of daily living, work performance, aesthetics and satisfaction assessed with the MHQ (0-100 scale).
|
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
|
Shoulder Pain and Disability Index (SPADI) Total Score
Időkeret: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Shoulder pain and disability assessed with SPADI questionnaire (0-100, lower scores indicate better outcomes).
|
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
|
Pain Catastrophizing scale (PCS) Total Score
Időkeret: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Maladaptive pain-related cognitions assessed with the PCS (0-52, higher scores indicate greater catastrophizing).
|
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
|
Tampa Scale for Kinesiophobia (TSK-11) Total Score
Időkeret: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Fear of movement assessed with the TSK-11 questionnaire (11-44, higher scores indicate greater kinesiophobia).
|
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
|
Active Wrist range of motion (degrees)
Időkeret: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Active wrist flexion, extension, radial deviation, ulnar deviation, pronation and supination measured with a universal goniometer (degrees).
|
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
|
Grip strength (Kg)
Időkeret: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Grip strength measured in kilograms using a Jamar dynamometer in standardized position.
|
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
|
Wrist joint position sense error (Degrees)
Időkeret: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
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.
|
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Incidence of virtual reality - related adverse events
Időkeret: From firsts intervention session through final intervention session (approximately 6 weeks).
|
Number of participants experiencing dizziness, nausea, visual discomfort, or disorientation during intervention sessions.
|
From firsts intervention session through final intervention session (approximately 6 weeks).
|
|
Intervention adherence
Időkeret: From firsts intervention session through final intervention session (approximately 6 weeks).
|
Percentage of prescribed sessions completed by each participant.
|
From firsts intervention session through final intervention session (approximately 6 weeks).
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2026. február 1.
Elsődleges befejezés (Becsült)
2026. szeptember 30.
A tanulmány befejezése (Becsült)
2026. december 31.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. június 2.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. június 2.
Első közzététel (Tényleges)
2026. június 8.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. június 8.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. június 2.
Utolsó ellenőrzés
2026. június 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- UMA-VR-HAND-2026-003
- CEUMA 24-2025-H (Registry Identifier: CEUMA: 24-2025-H)
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .