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Набор скоро начнётся NCT05490277

Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

Без фазы С лечением Chronic Stroke

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: Active Vibrotactile coordinated reset, Sham vibrotactile coordinated reset.
Кому может быть актуально
Состояния в реестре: Chronic Stroke. Базовые параметры: 18 лет — 80 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within stroke patients. vCR will be administered with a device called the Vibrotactile (VT) Brain Glove. vCR is expected to provide patients with a non-invasive therapy to aid in recovery from a stroke. This study will include a dedicated sham arm that will aid in understanding true treatment effects from vCR.

Вмешательства

  • Устройство Active Vibrotactile coordinated reset
    Participants will receive active vibrotactile coordinated reset (vCR) which sends gentle vibrations to the fingertips at a specific pattern. The purpose of the intervention is to test the efficacy of active vCR in comparison to sham vCR.
  • Устройство Sham vibrotactile coordinated reset
    Participants will receive sham vibrotactile coordinated reset (vCR) which sends gentle vibrations to the fingertips at a specific pattern. The purpose of the intervention is to test the efficacy of active vCR in comparison to sham vCR.

Первичные конечные точки

  • Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months [Срок оценки: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
  • Neuro Quality of Life Upper Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months [Срок оценки: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
Вторичные конечные точки (6)
  • Barthel Index for Activities of Daily Living change from baseline, 3 months, 4 months, 7months and 8 months [Срок оценки: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
  • Action Research Arm Test change from baseline, 3 months, 4 months, 7months and 8 months [Срок оценки: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
  • Timed Up and Go test change from baseline, 3 months, 4 months, 7months and 8 months [Срок оценки: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
  • Neuro Quality of Life Lower Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months [Срок оценки: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
  • Sensorimotor reaction time task [Срок оценки: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
  • Vibratory temporal discrimination task [Срок оценки: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]

Критерии участия

Критерии включения

  • Age at the time of enrollment: 18-80 years
  • Diagnosis of ischemic or hemorrhagic stroke
  • Disease period of more than 6 months
  • Mini Mental State Examination of at least 24 points
  • No medications that affect balance
  • Motor deficit
  • Use of Motricity Arm and Leg index to include impaired individuals with some functioning
  • Modified Rankin Scale for Neurologic Disability: Scores 3 or 4

Критерии исключения

  • Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression
  • Any current drug or alcohol abuse
  • History of recurrent or unprovoked seizures
  • Any neurological disorder treatments that involve intracranial surgery or device implantation
  • Participation in another drug, device or biologic trial concurrently or within the preceding days
  • Pregnancy, breastfeeding or wanting to become pregnant during the trial
  • History or presence of other major neurological or orthopedic diseases other than stroke that limits motor functioning or cognitive ability
  • More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, or ankle
  • Botox, baclofen or any other treatment for spasticity except for bracing or splinting within the previous 3 months
  • Must be able to communicate with staff
  • Severe sensory abnormalities of the fingers such as vibratory urticaria

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Stanford University — Stanford

Идентификаторы

NCT: NCT05490277 · 65197

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗