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Идёт набор NCT07633769

Virtual Reality-based Rehabilitation for Traumatic Hand and Wrist Injuries

Без фазы С лечением Wrist Injury Hand and Upper Limb Trauma Hand and Forearm Trauma Muskuloskeletal Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Immersive Virtual Reality Action Observation Therapy, Conventional Rehabilitation.
Кому может быть актуально
Состояния в реестре: Wrist Injury, Hand and Upper Limb Trauma, Hand and Forearm Trauma, Muskuloskeletal Diseases. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Use of Virtual Reality to Improve Sensorimotor Function in Patients With Traumatic Wrist and Hand Injuries

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Immersive Virtual Reality Action Observation Therapy
    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.
  • Другое Conventional Rehabilitation
    Standard rehabilitation program for traumatic wrist and hand injuries including active and passive mobilization, strengthening exercises, functional training, and pain management.

Первичные конечные точки

  • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • UMA — Málaga

Идентификаторы

NCT: NCT07633769 · UMA-VR-HAND-2026-003 · CEUMA 24-2025-H

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗