Virtual Reality-based Rehabilitation for Traumatic Hand and Wrist Injuries (AOT-VR-HAND)
2 de junho de 2026 atualizado por: Atenea Villalobos-García, University of Malaga
Use of Virtual Reality to Improve Sensorimotor Function in Patients With Traumatic Wrist and Hand Injuries
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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Málaga, Espanha, 29071
- Recrutamento
- UMA
-
Contato:
- Atenea Villalobos-García, Occupational therapist
- Número de telefone: 34 635840829
- E-mail: atevillagar@uma.es
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Adults aged 18 years or older.
- Diagnosis of a traumatic wrist and/or hand injury.
- Referred for rehabilitation treatment at the participating hand therapy unit.
- Ability to understand study procedures and provide written informed consent.
- Ability to participate in the virtual reality intervention.
Exclusion Criteria:
- Previous injury affecting the same hand.
- Associated upper-limb conditions, including tenosynovitis or Dupuytren's disease.
- Previous surgery involving the affected hand before the current traumatic injury.
- Corticosteroid or other therapeutic injection in the affected hand within the previous 3 weeks.
- Any physical, neurological, visual, vestibular, or medical condition that prevents safe use of the virtual reality device.
- Inability to comply with the study procedures or assessments.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: RV Group
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.
|
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.
Outros nomes:
|
|
Comparador Ativo: Hand Therapy Group
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.
|
Standard rehabilitation program for traumatic wrist and hand injuries including active and passive mobilization, strengthening exercises, functional training, and pain management.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Prazo: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention
|
Self-reported upper limb disability assessed with QuickDASH questionnaire (0-100, higher scores indicate greater disability).
|
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
Prazo: 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 and hand pain and function assessed with the PRWHE questionnaire (0-100, lower scores indicate better outcomes).
|
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
Prazo: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Hand-specific function, pain, activities of daily living, work performance, aesthetics and satisfaction assessed with the MHQ (0-100 scale).
|
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
Prazo: 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 assessed with SPADI questionnaire (0-100, lower scores indicate better outcomes).
|
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
Prazo: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Maladaptive pain-related cognitions assessed with the PCS (0-52, higher scores indicate greater catastrophizing).
|
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
Prazo: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Fear of movement assessed with the TSK-11 questionnaire (11-44, higher scores indicate greater kinesiophobia).
|
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)
Prazo: 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 flexion, extension, radial deviation, ulnar deviation, pronation and supination measured with a universal goniometer (degrees).
|
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)
Prazo: 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 measured in kilograms using a Jamar dynamometer in standardized position.
|
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)
Prazo: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
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 (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of virtual reality - related adverse events
Prazo: From firsts intervention session through final intervention session (approximately 6 weeks).
|
Number of participants experiencing dizziness, nausea, visual discomfort, or disorientation during intervention sessions.
|
From firsts intervention session through final intervention session (approximately 6 weeks).
|
|
Intervention adherence
Prazo: From firsts intervention session through final intervention session (approximately 6 weeks).
|
Percentage of prescribed sessions completed by each participant.
|
From firsts intervention session through final intervention session (approximately 6 weeks).
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2026
Conclusão Primária (Estimado)
30 de setembro de 2026
Conclusão do estudo (Estimado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de junho de 2026
Primeira postagem (Real)
8 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UMA-VR-HAND-2026-003
- CEUMA 24-2025-H (Identificador de registro: CEUMA: 24-2025-H)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .