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NCT Number: NCT07633769

Virtual Reality-based Rehabilitation for Traumatic Hand and Wrist 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.

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Key information

Conditions

Wrist Injury Arm Injuries Hand and Forearm Trauma Hand and Upper Limb Trauma Muskuloskeletal Diseases Wounds and Injuries Wrist Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMA

Málaga, 29071, Spain

Location status: Recruiting

Location contact

Atenea Villalobos-García, Occupational therapist

CONTACT

[email protected]

635840829 ext. 34

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immersive Virtual Reality Action Observation Therapy

Behavioral

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: IVR group

conventional rehabilitation

Other

Standard rehabilitation program for traumatic wrist and hand injuries including active and passive mobilization, strengthening exercises, functional training, and pain management.

Other names: CR group

Primary outcomes

  1. 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

    Self-reported upper limb disability assessed with QuickDASH questionnaire (0-100, higher scores indicate greater disability).

  2. 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.

    Wrist and hand pain and function assessed with the PRWHE questionnaire (0-100, lower scores indicate better outcomes).

  3. 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.

    Hand-specific function, pain, activities of daily living, work performance, aesthetics and satisfaction assessed with the MHQ (0-100 scale).

  4. 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.

    Shoulder pain and disability assessed with SPADI questionnaire (0-100, lower scores indicate better outcomes).

  5. 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.

    Maladaptive pain-related cognitions assessed with the PCS (0-52, higher scores indicate greater catastrophizing).

  6. 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.

    Fear of movement assessed with the TSK-11 questionnaire (11-44, higher scores indicate greater kinesiophobia).

  7. 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.

    Active wrist flexion, extension, radial deviation, ulnar deviation, pronation and supination measured with a universal goniometer (degrees).

  8. 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.

    Grip strength measured in kilograms using a Jamar dynamometer in standardized position.

  9. 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.

    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.

Other outcomes

  1. Incidence of virtual reality - related adverse events

    Time frame: From firsts intervention session through final intervention session (approximately 6 weeks).

    Number of participants experiencing dizziness, nausea, visual discomfort, or disorientation during intervention sessions.

  2. Intervention adherence

    Time frame: From firsts intervention session through final intervention session (approximately 6 weeks).

    Percentage of prescribed sessions completed by each participant.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

Use of Virtual Reality to Improve Sensorimotor Function in Patients With Traumatic Wrist and Hand Injuries

Acronym: AOT-VR-HAND

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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