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Идёт набор NCT06162858

Reaching Motion During Functional Activities

Без фазы С лечением Shoulder Arthropathy Associated With Other Conditions Healthy

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: IMU (Inertial Measurement Devices).
Кому может быть актуально
Состояния в реестре: Shoulder Arthropathy Associated With Other Conditions, Healthy. Базовые параметры: от 60 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
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Reaching Motion by the Elderly During Functional Activities. A Comparison Beween a Healthy Control Group and Patients With a Reverse Shoulder Arthroplasty

Обзор

Taking and moving objects is essential. When this becomes difficult, it affects daily functioning. This study aims to determine movement patterns, at the level of the shoulder, during different functional movements in elderly people aged 60 years and older. Movement patterns of people without shoulder problems and patients with a reverse shoulder prosthesis will be compared. These insights can contribute to improving functional rehabilitation in patients with a reverse shoulder prosthesis (RSA).

Подробное описание

This study aims to investigate how elderly people (60 years and older) without shoulder pain and patients with a reverse shoulder arthroplasty (60 years and older) perform functional reaching movements. Using IMUs (Inertial Measurement Units), the investigators want to look at mode of execution, relational positions of hand, elbow and shoulder in space, in relation to the trunk and each other, and any compensatory movements made by patients with a reverse shoulder arthroplasty.

At the time of testing, participants will first complete a series of questionnaires. These questionnaires will provide information about the daily functioning of all participants. The participants' shoulder strength will also be measured.

After applying the IMUs, the participant will first perform a maximal movement (active for participant) in 4 directions (forward and lateral lifting of arm, hand-to-neck , hand-to-back). Then the researcher will perform the same movements with the participant's arm (passive for participant). This will allow measurement of the maximum active and passive mobility of the shoulder. Next, the participant will be asked to place and take back a number of different objects (both in terms of size and weight) at predetermined heights.

The participants without shoulder pain will be tested once, the participants with a reverse shoulder arthroplasty we want to test 4 times. The participants without shoulder pain will be assigned to the control group. The participants with a reverse shoulder arthroplasty we want to test 4 times to monitor not only their movement pattern, but also any changes in this pattern .

The questionnaires, strength measurement and requested movements will be the same for both groups.

Analysis of these movements will provide us with insights that can help improve the functional rehabilitation of patients with a reverse shoulder prosthesis.

All participants with a reverse shoulder arthroplasty will be recruited at UZ, participants without shoulder pain will be recruited through different channels (these are not patients)

Вмешательства

  • Другое IMU (Inertial Measurement Devices)
    Functional placing and reaching of objects of different weights on different heights

Первичные конечные точки

  • IMU registration (3D kinematics upper limb) [Срок оценки: healthy control group: baseline]
  • IMU registration (3D kinematics upper limb) [Срок оценки: RSA group: 3 weeks post surgery]
  • IMU registration (3D kinematics upper limb) [Срок оценки: RSA group: 6 weeks post surgery]
  • IMU registration (3D kinematics upper limb) [Срок оценки: RSA group: 12 weeks post surgery]
  • IMU registration (3D kinematics upper limb) [Срок оценки: RSA group: 6 months post surgery]
  • IMU registration (3D kinematics upper limb) [Срок оценки: RSA group: 12 months post surgery]
Вторичные конечные точки (7)
  • SPADI_DV [Срок оценки: during procedure]
  • Constant- Murley Score [Срок оценки: during procedure]
  • EQ5D5L [Срок оценки: during procedure]
  • VAS-pain [Срок оценки: during procedure]
  • AROM [Срок оценки: during procedure]
  • PROM [Срок оценки: during procedure]
  • strength [Срок оценки: during procedure]

Критерии участия

Критерии включения

  • 60 years and older
  • no shoulder pain + no diagnosis of shoulder problem
  • primary reverse shoulder arthroplasty

Критерии исключения

  • younger than 60 years
  • shoulder pain at moment of testing
  • known shoulder problem ( incl. diagnosis)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Бельгия · 2 центра
  • Ghent University Hospital — Ghent
  • University Ghent — Ghent

Идентификаторы

NCT: NCT06162858 · ONZ-2023-0416

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗