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Идёт набор NCT06472986

Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS)

Без фазы С лечением Spinal Cord Injuries Spinal Cord Injury Cervical

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: Activity-based therapy and transcutaneous spinal cord stimulation.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries, Spinal Cord Injury Cervical. 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Feasibility and Efficacy of Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation for Neurorestoration of Upper Limbs After Cervical Spinal Cord Injury

Обзор

The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand recovery after cervical spinal cord injury.

Подробное описание

The ABT-TCSCS is a one-arm interventional study evaluating the feasibility and efficacy of activity-based therapy and transcutaneous spinal cord stimulation on neurorestoration of upper limbs after cervical spinal cord injury. Up to 24 individuals with SCI who suffer from tetraplegia will be treated with ABT-TCSCS. All participants will receive 12 sessions of ABT (4 weeks), followed by 28 sessions of ABT-TCSCS (7 weeks). Each session will last 1 hour and delivered 3 times per week. All study participants will be assessed at the start of the study (Baseline 1) and then re-assessed after 6 weeks (Baseline 2) to ensure that they are neurologically stable. The baseline assessment will consist of the International Standards of Neurological Classification of SCI (ISNCSCI), GRASSP Version 1, the Spinal Cord Independence Measure (SCIM) and the TRI hand function test (TRI-HFT). Participants will be re-assessed after receiving 12 sessions of ABT i.e after 4 weeks (Pre-cervical stimulation assessment) and then after receiving 28 sessions of combined ABT and neuromodulation i.e after 7 weeks (Post-intervention assessment).

Вмешательства

  • Другое Activity-based therapy and transcutaneous spinal cord stimulation
    Activity Based Therapy (ABT) is a method of neuro-rehabilitation that incorporates a high intensity, long duration and effortful engagement from the individual receiving therapy, to garner improvements in sensory and motor function. The ABT constitutes 4 types of exercises including: cardio-fitness, resistance, postural/weightbearing and functional exercises. TransCutaneous Spinal Cord Stimulation (TCSCS) stimulates spinal networks in the cervical region to neuro-modulate the descending motor co

Первичные конечные точки

  • International Standards of Neurological Classification of SCI (ISNCSCI) [Срок оценки: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS]
  • Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1 [Срок оценки: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS]
  • Spinal Cord Independence Measure (SCIM) [Срок оценки: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS]
  • TRI hand function test (TRI-HFT) [Срок оценки: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS]
  • Tactile Discrimination Test (TDT) [Срок оценки: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS]
Вторичные конечные точки (1)
  • Neurophysiological Assessment using surface electromyography (EMG) [Срок оценки: After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS]

Критерии участия

Критерии включения

  • Individuals with chronic traumatic and non-traumatic cervical SCI (ASIA classification A-incomplete\*\*, B, C, D) between C1-C8
  • Adults more than 18 years old
  • At least 6 months post-spinal cord injury
  • A score of 2 - 15 on the upper extremity motor score of the ISNCSCI
  • A score between 5 - 40 on GRASSP Version 1 Strength on at least one side
  • Individuals who are medically stable

Критерии исключения

  • Individuals with any other upper extremity deficit
  • Unable to provide informed consent
  • Unable to participate in an intensive rehabilitation outpatient program
  • Spasticity that limits the range of motion greater than 50% for the elbow or wrist

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Toronto Rehabilitation Institute — Toronto

Публикации

  • Kirshblum S, Botticello A, Lammertse DP, Marino RJ, Chiodo AE, Jha A. The impact of sacral sensory sparing in motor complete spinal cord injury. Arch Phys Med Rehabil. 2011 Mar;92(3):376-83. doi: 10.1016/j.apmr.2010.07.242. PMID 21353822
  • Marino RJ, Burns S, Graves DE, Leiby BE, Kirshblum S, Lammertse DP. Upper- and lower-extremity motor recovery after traumatic cervical spinal cord injury: an update from the national spinal cord injury database. Arch Phys Med Rehabil. 2011 Mar;92(3):369-75. doi: 10.1016/j.apmr.2010.09.027. PMID 21353821
  • Kalsi-Ryan S, Curt A, Verrier MC, Fehlings MG. Development of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP): reviewing measurement specific to the upper limb in tetraplegia. J Neurosurg Spine. 2012 Sep;17(1 Suppl):65-76. doi: 10.3171/2012.6.AOSPINE1258. PMID 22985372
  • Kalsi-Ryan S, Riehm LE, Tetreault L, Martin AR, Teoderascu F, Massicotte E, Curt A, Verrier MC, Velstra IM, Fehlings MG. Characteristics of Upper Limb Impairment Related to Degenerative Cervical Myelopathy: Development of a Sensitive Hand Assessment (Graded Redefined Assessment of Strength, Sensibility, and Prehension Version Myelopathy). Neurosurgery. 2020 Mar 1;86(3):E292-E299. doi: 10.1093/neur PMID 31792501
  • Kapadia N, Zivanovic V, Verrier M, Popovic MR. Toronto rehabilitation institute-hand function test: assessment of gross motor function in individuals with spinal cord injury. Top Spinal Cord Inj Rehabil. 2012 Spring;18(2):167-86. doi: 10.1310/sci1802-167. PMID 23459270
  • Gopaul U, Bayley MT, Kalsi-Ryan S. Combined Activity-Based Therapy and Cervical Spinal Cord Stimulation: Active Ingredients, Targets and Mechanisms of Actions to Optimize Neurorestoration of Upper Limb Function After Cervical Spinal Cord Injury. Physiother Res Int. 2025 Apr;30(2):e70036. doi: 10.1002/pri.70036. PMID 39927575

Идентификаторы

NCT: NCT06472986 · 20-6276

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗