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Идёт набор NCT06089915

Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI

Без фазы С лечением Cervical Vertebrae 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: Standard occupational therapy, Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton.
Кому может быть актуально
Состояния в реестре: Cervical Vertebrae Injury. 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
Словения
Следующий шаг
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Официальное название

Assessing Effectiveness of Robot-assisted Upper-limb Exercise in Persons After Cervical Spinal Cord Injury

Обзор

The aim of the project is to test the effectiveness of robot-assisted upper-limb exercise in persons after cervical spinal cord injury. In a randomised controlled two-arm trial, the effect of adding two types of robot-assisted upper-limb exercise to standard occupational therapy will be tested. Three primary and two secondary outcomes will be assessed using well-established measures.

Подробное описание

Unlike for persons after stroke, there is no high-quality evidence of the effectiveness of robot-assisted upper-limb exercise in persons after cervical spinal cord injury. For this reason, we are aiming to conduct a randomised trial. The trial will involve two groups of adult patients admitted to inpatient rehabilitation. One group will receive standard occupational therapy, tailored to the patient's needs and abilities, five times per week for 90 minutes. In addition to the standard occupational therapy, the other group will receive ten 30-minute session of robot-assisted exercise: five sessions of exercise for fingers and hand using a specialised device, and five sessions of gross-motor exercise using an exoskeleton. Three outcome measures will be used to comprehensively assess the patients at the beginning and at the end of the intervention, i.e., upon admission and discharge: the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP; general and Myelopathy version), the Spinal Cord Independence Measure (SCIM), and the Canadian Occupational Performance Measure (COPM). The progress in those measures will be compared between the two groups.

Вмешательства

  • Поведенческое Standard occupational therapy
    Standard occupational therapy as part of inpatient rehabilitation
  • Устройство Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton
    Exercise for fingers and hand using Amadeo device plus gross-motor exercise using Armeo Spring exoskeleton

Первичные конечные точки

  • Difference in Graded Redefined Assessment of Strength, Sensibility and Prehension Version 2 (GRASSP V2) score [Срок оценки: Before intervention (at admission) and after the intervention (on average after 3 weeks)]
  • Difference in Graded Redefined Assessment of Strength, Sensibility and Prehension - Mielopathy (GRASSP-M) score [Срок оценки: Before intervention (at admission) and after the intervention (on average after 3 weeks)]
Вторичные конечные точки (2)
  • Difference in Spinal Cord Independence Measure (SCIM) score [Срок оценки: Before intervention (at admission) and after the intervention (on average after 3 weeks)]
  • Difference in Canadian Occupational Performance Measure (COPM) results [Срок оценки: Before intervention (at admission) and after the intervention (on average after 3 weeks)]

Критерии участия

Критерии включения

  • ability to move unloaded upper limbs
  • at least 18 years of age
  • ability to sit for one hour
  • ability to understand the instructions for robot-assisted exercise

Критерии исключения

  • inability to sit for one hour
  • presence of hospital-acquired infection that requires isolation
  • bodily impairment other than spinal cord injury
  • inability to understand the instructions for robot-assisted exercise

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
Открытое
Основная цель
Лечение

Центры проведения

Словения · 1 центр
  • University Rehabilitation Institute, Republic of Slovenia — Ljubljana

Идентификаторы

NCT: NCT06089915 · URIS202301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗