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Набор скоро начнётся NCT07037628

Investigating the Impact of Spinal Cord Electrical Stimulation Combined With Individualized Physical Therapy on Lower Extremity Function in Patients With Spinal Cord Injury

— Наблюдательное Spinal Cord Injury Spinal Cord Injury Thoracic Spinal Cord Injury/Damage Spinal Cord Injury T1-L2

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Injury/Damage, Spinal Cord Injury T1-L2. Базовые параметры: 20 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
Тайвань
Следующий шаг
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Обзор

This study aims to understand the differences in the effects of two rehabilitation approaches on lower limb function recovery in patients with spinal cord injuries: 1. Spinal cord stimulation (SCS) combined with one-on-one physical therapy 2. One-on-one physical therapy alone

Подробное описание

This study adopts a prospective controlled design to observe and explore the effect of SCS combined with one-on-one physical therapy on the recovery of lower limb function in patients with spinal cord injury. The aims is to collect clinical practice data and provide reference for future related treatment strategies and care, hoping to increase the treatment options for rehabilitation of patients with spinal cord injury and improve their functional performance and quality of life.

Первичные конечные точки

  • American Spinal Injury Association (ASIA) Impairment Scale [Срок оценки: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • Modified Ashworth Scale (MAS) [Срок оценки: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • Handheld Dynamometer [Срок оценки: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • Spinal Cord Independence Measure (SCIM III) [Срок оценки: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • World Health Organization Quality-of-Life Scale [Срок оценки: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • Walking Index for Spinal Cord Injury (WISCI II) [Срок оценки: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]

Критерии участия

Критерии включения

  • Aged between 20 and 70 years.
  • Diagnosed with spinal cord injury, classified as ASIA Grade A-D.
  • Neurological level of injury between T1 and L2.
  • Spinal cord injury has stabilized (for at least 3 months).
  • Currently receiving standard treatment at Hualien Tzu Chi Hospital and referred by a neurosurgeon or orthopedic surgeon to receive spinal cord stimulation (SCS) and/or individualized physical therapy.
  • Capable of participating in one-on-one physical therapy sessions 3 to 5 times per week, and assessed by the medical team as able to complete at least a 3 weeks course of treatment.
  • Fully conscious, able to understand the study information, and willing to sign the consent form and participate in the full assessment process.

Критерии исключения

  • Individuals with severe brain injury, neurodegenerative diseases, or other major neurological disorders.
  • Those with severe fractures, joint contractures, or conditions preventing participation in lower limb training.
  • Individuals with a cardiac pacemaker or who are pregnant.
  • Those unable to comply with the treatment or assessment procedures.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Тайвань · 1 центр
  • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City

Идентификаторы

NCT: NCT07037628 · IRB114-106-B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗