- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07633769
Virtual Reality-based Rehabilitation for Traumatic Hand and Wrist Injuries (AOT-VR-HAND)
Use of Virtual Reality to Improve Sensorimotor Function in Patients With Traumatic Wrist and Hand Injuries
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Málaga, Spain, 29071
- Recruiting
- UMA
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Contact:
- Atenea Villalobos-García, Occupational therapist
- Phone Number: 34 635840829
- Email: atevillagar@uma.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
Other Names:
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Active Comparator: 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of virtual reality - related adverse events
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- UMA-VR-HAND-2026-003
- CEUMA 24-2025-H (Registry Identifier: CEUMA: 24-2025-H)
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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