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Идёт набор NCT07538323

Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function

Без фазы С лечением Distal Radius Fracture Colles Fracture Wrist Fracture Wrist Fractures

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: Supervised Exercise, Usual Care.
Кому может быть актуально
Состояния в реестре: Distal Radius Fracture, Colles Fracture, Wrist Fracture, Wrist Fractures. Базовые параметры: от 50 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
Дания
Следующий шаг
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Официальное название

Progressive Resistance and Flexibility Exercises Versus Usual Care Advice for Improving Pain and Function After Distal Radius Fracture in Adults Aged 50 Years or Over in Denmark: the WISE-DK Randomised Trial

Обзор

The goal of this clinical trial is to find out whether a therapist-guided exercise program helps people aged 50 and older recover better, in terms of pain and function, after a wrist fracture, compared to the usual care advice they would normally receive. The main question it aims to answer is: • Will participants who receive a therapist-supervised exercise program have better improvement in pain and function, as measured by the Patient Rated Wrist Evaluation questionnaire, six months after their injury? Researchers will compare these participants with those who receive usual care, which includes advice on self-management, to see if the supervised exercise program leads to greater recovery. Participants will: * Either receive supervised exercise, with a therapy session of up to 60 minutes and two additional sessions of up to 30 minutes each in addition to usual-care, or they will receive solely usual-care, consisting of advice on self-management. * Complete questionnaires electronically at baseline, 3-months, and 6-months.

Вмешательства

  • Другое Supervised Exercise
    Verbal advice, a leaflet, and instruction in a strength training program delivered by an occupational or physical therapist at the hospital or virtually. This is followed by two additional sessions with a therapist in the municipality, focusing on progression in the exercise program. Participants will receive written instructions (a Supervised Exercise workbook) along with a personal login to access a patient information video. The exercise program is a highly structured system of hand and uppe
  • Другое Usual Care
    Verbal advice and a leaflet provided at the hospital. Advice will include hand and wrist mobilization exercises to restore flexibility and guidance on building up activity gradually. Participants receiving solely usual care will not be provided with access to the intervention materials (the Supervised Exercise workbook).

Первичные конечные точки

  • Patient-Rated Wrist Evaluation (PRWE) [Срок оценки: Measured at baseline, 3 months and 6 months follow-up]
Вторичные конечные точки (9)
  • Wrist pain subscale measured using the Patient Rated Wrist Evaluation (PRWE) [Срок оценки: Baseline, 3 months and 6 months follow-up]
  • Wrist function subscale measured using the Patient Rated Wrist Evaluation (PRWE) [Срок оценки: Baseline, 3 months and 6 months follow-up]
  • PROMIS Physical Function Upper Extremity-Short Form 7a [Срок оценки: Baseline, 3 months and 6 months follow-up]
  • QuickDASH [Срок оценки: Baseline, 3 months and 6 months follow-up]
  • EuroQol 5 Dimensions (EQ-5D-5L) [Срок оценки: Baseline, 3 months and 6 months follow-up]
  • Self-Efficacy for Exercise scale (SEE) [Срок оценки: Baseline, 3 months and 6 months follow-up]
  • Exercise adherence measured by self-reported exercise frequency [Срок оценки: 3 months and 6 months follow-up]
  • Serious adverse events (SAEs) [Срок оценки: 3 months and 6 months follow-up]
  • Adverse events (AEs) [Срок оценки: 3 months and 6 months follow-up]

Критерии участия

Критерии включения

  • Distal radius fracture treated surgically or non-surgically
  • Willing and able to give informed consent

Критерии исключения

  • Injury is more than two months old
  • There is evidence that the patient would be unable to participate in therapy or a self-guided exercise program provided by a participating center or adhere to study procedures (including cognitive impairment and fracture/surgery complications such as Complex Regional Pain Syndrome)
  • No e-mail address to receive electronic questionnaires
  • Open fractures with a Gustilo \& Anderson grading >1

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

Дания · 1 центр
  • Aarhus University Hospital — Aarhus N

Идентификаторы

NCT: NCT07538323 · WISE-DK

Первоисточники (государственные реестры)

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