An interventional study of Immersive Virtual Reality Action Observation Therapy and Conventional Rehabilitation in Wrist Injury, Hand and Upper Limb Trauma and Hand and Forearm Trauma, sponsored by University of Malaga. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University of Malaga · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Behavioral: Immersive Virtual Reality Action Observation Therapy
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.
Other: Conventional Rehabilitation
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.
Also known as: IVR group
Standard rehabilitation program for traumatic wrist and hand injuries including active and passive mobilization, strengthening exercises, functional training, and pain management.
Also known as: CR group
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Self-reported upper limb disability assessed with QuickDASH questionnaire (0-100, higher scores indicate greater disability).
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
Patient-Rated Wrist and Hand Evaluation (PRWHE) Total Score
Wrist and hand pain and function assessed with the PRWHE questionnaire (0-100, lower scores indicate better outcomes).
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.
Michigan Hand Outcomes Questionnaire (MHQ) Total Score
Hand-specific function, pain, activities of daily living, work performance, aesthetics and satisfaction assessed with the MHQ (0-100 scale).
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 Index (SPADI) Total Score
Shoulder pain and disability assessed with SPADI questionnaire (0-100, lower scores indicate better outcomes).
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.
Pain Catastrophizing scale (PCS) Total Score
Maladaptive pain-related cognitions assessed with the PCS (0-52, higher scores indicate greater catastrophizing).
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.
Tampa Scale for Kinesiophobia (TSK-11) Total Score
Fear of movement assessed with the TSK-11 questionnaire (11-44, higher scores indicate greater kinesiophobia).
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 range of motion (degrees)
Active wrist flexion, extension, radial deviation, ulnar deviation, pronation and supination measured with a universal goniometer (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.
Grip strength (Kg)
Grip strength measured in kilograms using a Jamar dynamometer in standardized position.
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 joint position sense error (Degrees)
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.
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.
Incidence of virtual reality - related adverse events
Number of participants experiencing dizziness, nausea, visual discomfort, or disorientation during intervention sessions.
Time frame: From firsts intervention session through final intervention session (approximately 6 weeks).
Intervention adherence
Percentage of prescribed sessions completed by each participant.
Time frame: From firsts intervention session through final intervention session (approximately 6 weeks).
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University of Malaga