Virtual Reality Therapy for Wrist and Hand Injury Recovery

NCT07408622 | Not Yet Recruiting

• 2 other identifiers: UMA-AOTRVWH-2025-001UMA-AOTRV-2026
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this randomized clinical trial is to find out whether an early neuro-functional rehabilitation program using virtual reality and action observation can improve recovery after a traumatic injury of the wrist or hand that requires immobilization in a cast or splint. After a fracture or other traumatic injury, the wrist and hand often have to be immobilized for several weeks. This rest is necessary for the bone and soft tissues to heal, but it also has negative effects. The muscles become weaker, joint movement is reduced, and the sense of position and movement (proprioception) worsens. Immobilization also produces fast changes in the brain areas that control movement, which may slow down recovery and increase the risk of long-lasting pain, stiffness, and disability. This study will compare two rehabilitation programs: Control group: participants will receive conventional rehabilitation after the cast or splint is removed, following the usual care of the hand therapy and traumatology services. Experimental group: in addition to conventional rehabilitation, participants will follow a specific program that combines action observation therapy with immersive virtual reality (AOT+VR). During each session, patients will watch first-person videos of functional wrist and hand movements through a virtual reality headset and then practice these same movements. The program includes about 12 sessions of 45 minutes over 6 weeks, starting during the immobilization period and continuing after the cast or splint is removed. Adults between 18 and 70 years with traumatic injuries of the wrist and/or hand (such as distal radius, carpal or metacarpal fractures, or tendon and ligament injuries) who need immobilization for 2 to 8 weeks will be invited to participate. Researchers will measure: Sensorimotor cortical activity associated with action observation and execution using electroencephalography (EEG), pain, disability, and function of the upper limb using validated questionnaires, Physical measures such as wrist range of motion, grip strength, and proprioception, Psychological factors such as fear of movement and pain catastrophizing, Feasibility, adherence to the program, side effects, and patient satisfaction. The main hypothesis is that the AOT+VR program, started early during immobilization, will help maintain brain excitability, reduce pain and psychological barriers, and lead to faster and more complete functional recovery of the wrist and hand compared with conventional rehabilitation alone.

Conditions

Wrist Injuries; Hand and Upper Limb Trauma; Muskuloskeletan Pain

Keywords

Virtual reality; Action observation therapy; Upper limb rehabilitation; sensorimotor cortical activity

Outcome Measures

Primary Outcomes (2)

• Event-Related Potential (ERP) Amplitude during action observation and execution

  Sensorimotor cortical activity quantified as peak amplitude (µV) of event-related potentials time-locked to action observation and action execution tasks, recorded using electroencephalography (EEG) with the Emotiv PRO system.

  Baseline (within 5 days of inmobilization onset); 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.

• Event-Related Desynchronization/Synchronization (ERD/ERS) in Mu (8-13 Hz) and Beta (13-30 Hz) Bands

  Sensorimotor cortical activity quantified as percentage change in spectral power (%) representing ERD/ERS within the mu (8-13 Hz) and beta (13-30 Hz) frequency bands over sensorimotor cortical regions during action observation and execution tasks, recorded using EEG with the Emotiv PRO system.

  Baseline (within 5 days of inmobilization onset); 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.

Secondary Outcomes (9)

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score

  Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.

• Patient-Rated Wrist and Hand Evaluation (PRWHE) Total Score

  Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.

• Michigan Hand Outcomes Questionnaire (MHQ) Total Score

  Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.

• Shoulder Pain and Disability index (SPADI) Total Score

  Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.

• Pain Catastrophizing scale (PCS) Total Score

  Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.

Other Outcomes (3)

• Incidence of virtual reality - related adverse events

  From firts intervention session through final intervention session (approximately 6 weeks).

• Intervention adherence

  From first intervention session through final intervention session (approximately 6 weeks).

• Participant satisfaction with virtual reality intervention

  Inmediatly after completion of the 6-week intervention period.

Study Arms (2)

Conventional rehabilitation

NO INTERVENTION

Adult patients (18-70 years old) with traumatic wrist and/or hand injury (distal radius fractures, scaphoid, metacarpal, phalangeal, or other carpal bone fractures; or tendinous/ligamentous injuries) requiring immobilization with cast or splint for 2-8 weeks. Standard conventional rehabilitation protocol during immobilization and post-immobilization periods. Participants will receive only usual clinical care without additional virtual reality intervention.

Action Observation therapy with Virtual Reality

EXPERIMENTAL

The same adult patients (18-70 years old) with traumatic wrist and/or hand injury requiring immobilization (2-8 weeks). Structured multimodal intervention: 12 sessions (±2 sessions) of approximately 45 minutes each, delivered at 2 sessions per week over 6 weeks, both during and after the immobilization period. Session components: (1) Observation of first-person perspective videos through Meta Quest 3S virtual reality headset displaying unilateral or bilateral actions (2 min), (2) Execution of observed movements without the device (3 min), with 3 cycles per session and rest intervals. Exercise progression: Sessions 1-2 (simple movements without gravity); Sessions 3-4 (object-directed actions); Sessions 5-6 (simple anti-gravity movements); Sessions 7-8 (functional bilateral activities); Sessions 9-10 (complex visuospatial activities); Sessions 11-12 (complex sequences and fine precision).

Other: Virtual reality

Interventions

Virtual reality OTHER

The AOT+VR intervention is distinguished by its novel application of immersive first-person perspective virtual reality combined with action observation therapy specifically during the immobilization period in traumatic wrist and hand injuries, targeting the critical early window (first 12-48 hours) when maladaptive neuroplasticity begins. Unlike previous studies focused on neurological patients or post-immobilization phases, this protocol integrates longitudinal assessment of sensorimotor cortical activity using electroencephalography (EEG) alongside functional and psychosocial measures, establishing direct correlations between cortical preservation and clinical recovery not previously documented in traumatic upper limb injuries.

Action Observation therapy with Virtual Reality

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years old.
• Diagnosis of traumatic wrist and/or hand injury within 5 days of injury onset.
• Traumatic injury types include: distal radius fractures, scaphoid fractures, metacarpal fractures, phalangeal fractures, other carpal bone fractures, tendinous injuries, or ligamentous injuries.
• Require immobilization with cast or splint for 2-8 weeks.
• Ability to provide written informed consent.
• Ability to understand and follow study instructions.
• Sufficient mobility and residual manual capacity to participate in virtual reality sessions and physical assessments.

You may not qualify if:

• History of neurological disease affecting motor control (stroke, Parkinson's disease, multiple sclerosis).
• Severe psychiatric disorders (psychosis, severe depression requiring hospitalization).
• Current involvement in other rehabilitation protocols or clinical trials.
• Contraindications for using virtual reality.

Sponsors & Collaborators

• University of Malaga: lead

MeSH Terms

Conditions

Wrist Injuries

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will be anonymized with a number and randomized with a web program (random.org)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02