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Идёт набор NCT07245706

Shoulder Health After Rehabilitation and Performance Training

Без фазы С лечением Spinal Cord Injury Nervous System Diseases Musculoskeletal Diseases Injury

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: Strength training.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injury, Nervous System Diseases, Musculoskeletal Diseases, Injury. Базовые параметры: 18 лет — 70 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
Швейцария
Следующий шаг
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Официальное название

Ensuring Shoulder Health as a Key Factor for Long Term Health and Functioning of Manual Wheelchair Users

Обзор

The goal of this study is to investigate the impact of a home-based shoulder strength training on the overall shoulder health in manual wheelchair users, and if the timepoint of such a training makes a difference. The study is focusing on persons with a spinal cord injury in the thoracic or lumbar region of the spine, that have only recently been injured and will soon be discharged from primary rehabilitation. The shoulder training will take place either 3 or 12 months after discharge from primary rehabilitation and will be carried out twice a week for 12 weeks. There are six measurements occurring every three months, which leads to an overall duration of 15 months. The measurements consist of: * Questionnaires about independence in daily life, participation, quality of life and physical activity * Assessment of shoulder strength, range of motion and function * Measurement of the daily wheelchair use during one week via sensors that are fixed to the wheelchair and wrist * one further questionnaire at the end of the measurement week about the occurrence of shoulder pain Additionally, on four of the six measurement timepoints, a magnet resonance image (MRI) of the shoulder will be taken to assess the shoulder status (pathology, muscle volume and quality). Though all these measurements the researchers can additionally assess the load of daily life on the shoulders, and how well this matches the preparation during the primary rehabilitation.

Вмешательства

  • Другое Strength training
    Individualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks

Первичные конечные точки

  • change in experienced shoulder pain during activities of daily life [Срок оценки: Before and after the training intervention (3 months apart)]
Вторичные конечные точки (12)
  • Experienced shoulder pain during activities of daily life [Срок оценки: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge]
  • Painful events [Срок оценки: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge]
  • Shoulder strength [Срок оценки: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge]
  • Shoulder range of motion [Срок оценки: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge]
  • Shoulder stability [Срок оценки: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge]
  • Heart rate during daily life [Срок оценки: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge]
  • Wheelchair use during daily life [Срок оценки: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each]
  • Shoulder loading acivities of daily life [Срок оценки: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each]
  • Shoulder load during activities of daily life [Срок оценки: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each]
  • Shoulder pathology [Срок оценки: 3, 6, 12 and 15 months after discharge]
  • Shoulder muscle volume [Срок оценки: 3, 6, 12 and 15 months after discharge]
  • Shoulder muscle quality [Срок оценки: 3, 6, 12 and 15 months after discharge]

Критерии участия

Критерии включения

  • Persons with a paraplegia below T2
  • Manual wheelchair user
  • Age 18 - 70 years
  • At discharge from initial rehabilitation

Критерии исключения

  • Trauma or surgery of the shoulder with medical indication for immobilization of more than four weeks
  • Constant use of power assistance for the wheelchair
  • Any surgical implants that exclude the participant for MRI assessments of the shoulder
  • Inability to follow the study instructions, e.g., mental health problems, language problems, dementia, claustrophobia (for MRI) etc.
  • Persons with congenital conditions leading to SCI, SCI in the context of palliative care, neurodegenerative disorders, and Guillain-Barré syndrome
  • Pregnancy

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
Профилактика

Центры проведения

Швейцария · 1 центр
  • Swiss Paraplegic Research — Nottwil

Идентификаторы

NCT: NCT07245706 · 2025-16 · 10.003.991

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗