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Набор по приглашению NCT05191121

Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI)

Без фазы С лечением Cervical Spinal Cord 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: FTP Alone, FTP+Con-FES, FTP+WPHF-FES.
Кому может быть актуально
Состояния в реестре: Cervical Spinal Cord 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
США
Следующий шаг
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Официальное название

Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI): A Randomized Controlled Trial of Three Interventions

Обзор

Ninety-nine individuals meeting the study's inclusion/exclusion criteria will be enrolled in this study. The objective of this study is to evaluate three different therapeutic approaches to synergistically retrain functional movement patterns of the upper extremities in combination with trunk stabilization to promote neurologic and functional recovery after SCI. Each subject will complete 40 sessions of intervention. Subjects will also complete a Baseline Evaluation (week 0), Re-Evaluation (week 4), Post Treatment Evaluation (week 8), and a Follow-Up Evaluation (week 12).

Вмешательства

  • Поведенческое FTP Alone
    Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins).
  • Поведенческое FTP+Con-FES
    Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing conventional parameter FES.
  • Поведенческое FTP+WPHF-FES
    Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing wide pulse, high frequency parameter FES.

Первичные конечные точки

  • Capabilities of Upper Extremity Test (CUE-T) [Срок оценки: Week 0 to Week 12]
Вторичные конечные точки (12)
  • Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) [Срок оценки: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Level [Срок оценки: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Level [Срок оценки: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury [Срок оценки: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sacral Sparing [Срок оценки: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Impairment Grade [Срок оценки: Week 0, Week 8, and Week 12]
  • Pinch Force [Срок оценки: Week 0, Week 8, and Week 12]
  • Grasp Force [Срок оценки: Week 0, Week 8, and Week 12]
  • Modified Functional Reach (MFR) [Срок оценки: Week 0, Week 8, and Week 12]
  • Global Rating of Change (GRC) [Срок оценки: Week 0, Week 8, and Week 12]
  • NeuroRecovery Scale (NRS) [Срок оценки: Week 0 and Week 4]
  • Demographic Information [Срок оценки: Week 0]

Критерии участия

Критерии включения

  • History of traumatic SCI
  • Less than 5months post SCI
  • SCI injury level C1-C8
  • SCI categorized as AIS B-D
  • Currently receiving inpatient rehabilitation at Craig Hospital
  • Passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
  • Demonstrate motor response to electrical stimulation in majority of UE muscle groups below level of injury (tested during screening)
  • No complicating physical or cognitive conditions (as determined by their physician) that would preclude safe use of electrical stimulation
  • Able to complete study as an outpatient if discharged from inpatient rehabilitation before completing 40 sessions of training

Критерии исключения

  • Unstable chronic cardiac or respiratory complaints
  • Current or history of UE contracture or skin pressure injuries that might interfere with intervention
  • Received Botox injections within the last 3 months
  • Pregnant
  • Implanted devices including: pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intra-thecal pump.

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

США · 1 центр
  • Craig Hospital — Englewood

Идентификаторы

NCT: NCT05191121 · 1847023-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗