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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Event-Related Potential (ERP) Amplitude during action observation and execution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Participants will be anonymized with a number and randomized with a web program (random.org)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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).
干预措施: Virtual reality (Other)
结局指标
主要结局
Event-Related Potential (ERP) Amplitude during action observation and execution
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Tampa Scale for Kinesiophobia (TSK-11) Total Score(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)(Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.)
- Grip Strenght (kg)(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)(Baseline (within 5 days of inmobilization onset), 24-48 hours after cast/splint removal; 6 weeks after cast/splint removal.)
研究者
Atenea Villalobos-García
Principal Investigator
University of Malaga