- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07408622
Virtual Reality Therapy for Wrist and Hand Injury Recovery (AOT+VR)
Action Observation Therapy Combined With Immersive Virtual Reality to Prevent Disuse-induced Cortical Plasticity During Immobilization in Patients With Traumatic Wrist and Hand Injuries: A Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Traumatic injuries of the wrist and hand are common causes of disability of the upper limb in adults. They frequently require a period of immobilization in a cast or splint to allow bone and soft tissues to heal. However, prolonged immobilization is associated with muscle atrophy, reduced strength, joint stiffness, proprioceptive deficits and, importantly, rapid neuroplastic changes in the motor cortex and related brain networks. These changes contribute to a maladaptive pattern of "disuse plasticity" that may persist after immobilization and is linked to chronic pain, fear of movement, and incomplete functional recovery.
Recent research shows that brain plasticity can be positively modulated through interventions based on motor representation, such as motor imagery and action observation therapy (AOT). In AOT, patients watch goal-directed movements that are similar to the actions they need to relearn. This activates the mirror neuron system and motor cortical areas even when the limb is not actively moving. Immersive virtual reality (VR) can enhance these effects by providing a first-person, three-dimensional environment that increases attention, motivation, sense of presence, and perceived control.
This study proposes an early neuro-functional intervention that combines AOT with immersive VR (AOT+VR) during and after the immobilization period in patients with traumatic wrist and hand injuries. The trial is designed as a randomized, controlled, parallel-group clinical study. Eligible participants (18-70 years, traumatic wrist/hand injury requiring 2-8 weeks of immobilization) will be randomly assigned to:
a control group, receiving only conventional rehabilitation according to standard clinical practice after immobilization, or an experimental group, receiving the same conventional rehabilitation plus the structured AOT+VR program.
The experimental protocol consists of approximately 12 sessions (±2), 45 minutes each, delivered twice per week over 6 weeks. In each session, participants use a VR headset (Meta Quest 3S) to observe videos of functional, uni- and bimanual upper-limb tasks from a first-person perspective (for example, reaching, grasping objects, using cutlery, writing, or daily-life activities). After each observation period, the headset is removed and the participant executes the observed movements with the affected limb as tolerated, repeating this observation-execution cycle several times per session. Exercises progress gradually from simple movements without gravity to complex functional tasks, allowing individual adaptation. Sessions are stopped immediately if adverse effects such as dizziness, nausea, or disorientation appear.
Outcome assessments are performed at three time points: baseline (within the first 5 days after starting immobilization), post-immobilization (24-48 hours after cast or splint removal), and follow-up (6 weeks after post-immobilization).
The primary outcome is sensorimotor cortical activity associated with action observation and execution, assessed using electroencephalography (EEG). Neurophysiological markers include event-related potentials (ERPs) time-locked to action observation and execution tasks, and event-related desyinchronization/synchronization (ERD/ERS) within the mu (8-13 hz) and beta (13-30 hz) frecuency bands over sensorimotor cortical regions. Secondary outcomes include pain and perceived disability (PRWE, QuickDASH, MHQ, SPADI), psychological factors (Tampa Scale of Kinesiophobia-11, Pain Catastrophizing Scale), physical measures of wrist range of motion, grip strength, proprioception, and feasibility and safety indicators (recruitment and adherence rates, adverse events related to VR or TMS, completeness of data and participant satisfaction).
The central hypothesis is that early AOT+VR will attenuate the reduction in sensorimotor cortical activity associated with immobilization, support more adaptive brain reorganization, and lead to better clinical outcomes than conventional care alone. By integrating neurophysiological, functional, and psychological measures, the study aims to clarify the mechanisms of action of AOT+VR and to determine whether this low-risk, technology-supported intervention is feasible and acceptable in real clinical settings for early rehabilitation after traumatic wrist and hand injuries.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Málaga
-
Málaga, Málaga, Spain, 29100
- Universidad de Málaga
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 |
|---|---|
|
No Intervention: Conventional rehabilitation
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. |
|
|
Experimental: Action Observation therapy with Virtual Reality
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). |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Event-Related Potential (ERP) Amplitude during action observation and execution
Time Frame: Baseline (within 5 days of inmobilization onset); 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
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
Time Frame: Baseline (within 5 days of inmobilization onset); 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Time Frame: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
Self-reported upper limb disability assessed with QuickDASH quesrionnaire (0-100, higher scores indicate greater disability).
|
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
Time Frame: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
Wrist and hand pain and function assessed with the PRWHE questionnaire (0-100, lower scores indicate better outcomes).
|
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
Time Frame: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
Hand-specific function, pain, activities of daily living, work performance, aesthetics and satisfaction assessed with the MHQ (0-100 scale).
|
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
Time Frame: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
Shoulder pain and disability assessed with SPADI questionnaire (0-100, lower scores indicate better outcomes).
|
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
Time Frame: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
Maladaptative pain-related cognitions assessed with the PCS (0-52, higher scores indicate greater catastrophizing).
|
Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
|
Tampa Scale for Kinesiophobia (TSK-11) Total Score
Time Frame: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
Fear of movement assessed with the TSK-11 questionnaire (11-44, higher scores indicate greater kinesiophobia).
|
Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
|
Active Wrist range of motion (degrees)
Time Frame: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
Active wrist flexion, extension, radial deviation, ulnar deviation, pronation and supination measured with a universal goniometer (degrees).
|
Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
|
Grip Strenght (kg)
Time Frame: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
Grip strenght measured in kilograms using a Jamar dynamometer in standardized position.
|
Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
|
Wrist joint position sense error (Degrees)
Time Frame: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
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 (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of virtual reality - related adverse events
Time Frame: From firts intervention session through final intervention session (approximately 6 weeks).
|
Number of participants experiencing dizziness, nausea, visual discomfort, or disorientation during intervention sessions.
|
From firts intervention session through final intervention session (approximately 6 weeks).
|
|
Intervention adherence
Time Frame: From first intervention session through final intervention session (approximately 6 weeks).
|
Percentage of prescribed sessions completed by each participant.
|
From first intervention session through final intervention session (approximately 6 weeks).
|
|
Participant satisfaction with virtual reality intervention
Time Frame: Inmediatly after completion of the 6-week intervention period.
|
Participant-reported satisfaction assessed using a 5-point Likert scale questionnaire.
|
Inmediatly after completion of the 6-week intervention period.
|
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMA-AOTRVWH-2025-001
- UMA-AOTRV-2026 (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.
Clinical Trials on Wrist Injuries
-
Sarasota Memorial Health Care SystemEnrolling by invitationWrist FractureUnited States
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRecruiting
-
Hospital San Carlos, MadridCompleted
-
Pacific Northwest University of Health SciencesSumma Health SystemCompletedWrist Fracture
-
Azienda Unita Sanitaria Locale di PiacenzaCompletedEdema Arm | Fracture; WristItaly
-
Ente Ospedaliero Cantonale, BellinzonaTerminated
-
Sohag UniversityRecruiting
-
Pamukkale UniversityNot yet recruitingDistal Radius FractureTurkey (Türkiye)
-
University of OpoleRecruiting
-
University of MalagaNot yet recruiting
Clinical Trials on Virtual reality
-
Institut National de la Santé Et de la Recherche...RecruitingSchizophrenia | Bipolar DisorderFrance
-
Eskisehir Osmangazi UniversityNot yet recruiting
-
The University of Hong KongCompleted
-
University of PennsylvaniaRecruiting
-
Istanbul University - CerrahpasaCompletedCancer | AnxietyTurkey
-
Cihat OzyılmazCompletedChild | Anxiety | FearTurkey
-
National University of MalaysiaRecruitingPleural EffusionMalaysia
-
Stanford UniversityTerminatedConversion Disorder | Non-epileptic Seizures | Functional Neurological Disorder | Functional Movement Disorder | Psychogenic Movement DisorderUnited States
-
University of WashingtonNational Institutes of Health (NIH); University of Texas; National Institute...Completed
-
Children's Hospital Los AngelesNot yet recruitingProcedural Pain | Procedural Anxiety