Wrist InjuriesAOT+VRNCT07408622
Virtual Reality Therapy for Wrist and Hand Injury Recovery
A study testing Virtual reality in people with Wrist Injuries and Hand and Upper Limb Trauma, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wrist Injuries, Hand and Upper Limb Trauma, Muskuloskeletan Pain
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Virtual reality
- Keywords
- Virtual reality, Action observation therapy, Upper limb rehabilitation, sensorimotor cortical activity
- Medical subject headings
- Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Self-reported upper limb disability assessed with QuickDASH quesrionnaire (0-100, higher scores indicate greater disability).
Measured: 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
Wrist and hand pain and function assessed with the PRWHE questionnaire (0-100, lower scores indicate better outcomes).
Measured: 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
Hand-specific function, pain, activities of daily living, work performance, aesthetics and satisfaction assessed with the MHQ (0-100 scale).
Measured: 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
Shoulder pain and disability assessed with SPADI questionnaire (0-100, lower scores indicate better outcomes).
Measured: 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
Maladaptative pain-related cognitions assessed with the PCS (0-52, higher scores indicate greater catastrophizing).
Measured: 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
Fear of movement assessed with the TSK-11 questionnaire (11-44, higher scores indicate greater kinesiophobia).
Measured: 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)
Active wrist flexion, extension, radial deviation, ulnar deviation, pronation and supination measured with a universal goniometer (degrees).
Measured: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
Grip Strenght (kg)
Grip strenght measured in kilograms using a Jamar dynamometer in standardized position.
Measured: 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)
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.
Measured: Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atenea Villalobos-García, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408622
- Sponsor's protocol ID
- UMA-AOTRVWH-2025-001
- Other IDs
- UMA-AOTRV-2026
- Acronym
- AOT+VR
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07408622
- Acronym / sponsor ID
- AOT+VR / UMA-AOTRVWH-2025-001
- Keywords
- Virtual reality, Action observation therapy, Upper limb rehabilitation, sensorimotor cortical activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Virtual realityThe 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityThe 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. | Other | Action Observation therapy with Virtual Reality |
Primary outcome
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.
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.
9 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Wrist Injuries and Hand and Upper Limb Trauma, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.