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Набор скоро начнётся NCT07668544

Kinesiophobia and Functional Outcomes in Hand Injuries

Без фазы С лечением Hand Injuries

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: Standard Surgical Treatment and Routine Postoperative Care.
Кому может быть актуально
Состояния в реестре: Hand Injuries. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Kinesiophobia Level on Functional Outcomes in Surgically Performed Hand Injuries

Обзор

Hand and forearm injuries are among the most common traumatic injuries and may result in substantial functional limitations, reduced work capacity, and decreased quality of life. Despite advances in surgical repair techniques, recovery outcomes vary considerably among individuals with similar injury characteristics. Psychological factors, particularly fear of movement or reinjury (kinesiophobia), may influence rehabilitation participation and functional recovery after injury. The aim of this prospective observational study is to investigate the relationship between early kinesiophobia levels and functional outcomes in adults who undergo surgical treatment for traumatic hand or forearm lacerations. Kinesiophobia will be assessed during the acute post-injury period (within 1-5 days after injury) using the Tampa Scale of Kinesiophobia. Injury severity will be evaluated using the Modified Hand Injury Severity Classification (MHISC/MEYCS). Participants will be followed for 12 weeks after injury. Functional recovery will be assessed at the 8th week using the Buck-Gramcko Score and the Sollerman Hand Function Test, and at the 12th week using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and hand grip strength measurements. The study will examine whether higher levels of early kinesiophobia are associated with greater injury severity and poorer functional recovery. Findings from this study may help identify patients at risk for delayed recovery and support the development of early rehabilitation strategies targeting psychological as well as physical aspects of hand injury recovery.

Вмешательства

  • Другое Standard Surgical Treatment and Routine Postoperative Care
    Participants with traumatic hand or forearm injuries will receive surgical treatment and postoperative management according to routine clinical practice and the treating surgeon's decision. No experimental treatment, device, medication, or rehabilitation protocol will be administered as part of the study. The study is observational in nature and aims to evaluate the relationship between early kinesiophobia levels, injury severity, and subsequent functional outcomes following standard surgical ca

Первичные конечные точки

  • Disabilities of the Arm, Shoulder and Hand (DASH) Score [Срок оценки: 12 weeks after injury]
Вторичные конечные точки (5)
  • Hand Grip Strength [Срок оценки: 12 weeks after injury]
  • Buck-Gramcko Functional Score [Срок оценки: 8 weeks after injury]
  • Sollerman Hand Function Test Score [Срок оценки: 8 weeks after injury]
  • Tampa Scale of Kinesiophobia (TSK) Score [Срок оценки: Within 1-5 days after injury]
  • Modified Hand Injury Severity Classification (MHISC/MEYCS) Score [Срок оценки: Within 1-5 days after injury]

Критерии участия

Критерии включения

Adults aged 18 years and older. Patients presenting to the emergency department with traumatic hand or forearm lacerations requiring surgical treatment.

Injury involving one or more anatomical structures of the hand or forearm (skin, tendon, nerve, vessel, or combined injuries).

Assessment within 1-5 days following injury. Ability to understand and complete study questionnaires and functional assessments.

Provision of written informed consent. Willingness to participate in follow-up assessments at 8 and 12 weeks after injury.

Критерии исключения

Age younger than 18 years. Cognitive impairment, severe psychiatric disorder, or communication problems preventing completion of questionnaires.

Previous major injury, surgery, or permanent functional impairment of the affected upper extremity.

Polytrauma or additional injuries that may substantially affect upper extremity function or rehabilitation outcomes.

Neurological disorders affecting upper extremity function (e.g., stroke, peripheral neuropathy, spinal cord injury).

Severe musculoskeletal disorders of the upper extremity unrelated to the index injury.

Inability or unwillingness to attend follow-up evaluations. Refusal to provide informed consent

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Cantero-Tellez R, Rider J, Cruz-Gambero L, Villafane JH, Valdes K. Kinesiophobia, catastrophizing, and the duration of immobilization: A prospective study on factors associated with shoulder disability following wrist-hand injuries. J Hand Ther. 2025 Jul-Sep;38(3):477-482. doi: 10.1016/j.jht.2024.08.004. Epub 2025 Jan 6. PMID 39765429

Идентификаторы

NCT: NCT07668544 · MarmaraUni-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗