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Идёт набор NCT05621980

Finger Movement Training After Stroke

Без фазы С лечением 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: Actuated Virtual Keyboard (AVK) system, Occupational Therapy (OT).
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: от 21 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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Официальное название

A Multimodal Intervention to Improve Manual Dexterity in Subacute Stroke Survivors

Обзор

Human development as a species has been strongly associated with the ability to dexterously manipulate objects and tools. Unfortunately, current therapy efforts typically fail to restore fine manual control after stroke. The goal of this study is to evaluate a new intervention that would combine targeted electrical stimulation of selected nerves with use a soft, pneumatically actuated hand exoskeleton to enhance repetitive practice of independent movements of the fingers and thumb in order to improve rehabilitation of hand function after stroke. The investigators will recruit stroke survivors in the subacute phase of recovery (2-18 months post-stroke). These participants will be involved in a 5-week intervention involving 15 training sessions. During these sessions, participants will train independent movement of the digits of the paretic hand. Evaluation of motor control of the paretic hand will occur prior to initiation of training, at the midpoint of the training period, after completion of training, and one month later.

Вмешательства

  • Поведенческое Actuated Virtual Keyboard (AVK) system
    The participant controls an avatar hand by the movement of their own digits. Each avatar digit corresponds to a given virtual key. "Sufficient" digit flexion results in "playing" of that key, with visual and auditory feedback of key strike. Participants will wear a soft exoskeleton, the PneuGlove, with embedded bend sensors to provide real-time measurement of digit flexion. Pneumatic resistance to flexion can be applied to each digit independently, along with extension assistance, through air ch
  • Поведенческое Occupational Therapy (OT)
    Traditional occupational therapy training sessions.

Первичные конечные точки

  • Change of Jebsen-Taylor Hand Function Test (JTHFT) [Срок оценки: Change of value from before the intervention to immediately after the intervention.]
Вторичные конечные точки (5)
  • Change of Lateral pinch strength [Срок оценки: Change of value from before the intervention to immediately after the intervention.]
  • Change of 3-point pinch strength [Срок оценки: Change of value from before the intervention to immediately after the intervention.]
  • Change of Touch sensitivity [Срок оценки: Change of value from before the intervention to immediately after the intervention.]
  • Change of Box and Blocks Test (BBT) [Срок оценки: Change of value from before the intervention to immediately after the intervention.]
  • Change of 9-Hole Peg Test (9PHT) [Срок оценки: Change of value from before the intervention to immediately after the intervention.]

Критерии участия

Критерии включения

  • A single, unilateral stroke 2-18 months prior to enrollment
  • Moderate to mild hand impairment, as determined by a rating of Stage 4-6 on the Stage of Hand section of the Chedoke-McMaster Stroke Assessment
  • Visual capacity to discern specific shapes on the computer screen
  • Capacity to provide informed consent

Критерии исключения

  • Rigid contractures in the joints of the upper limbs, or orthopedic issues precluding joint movement
  • Hemispatial neglect (as assessed by the Behavioral Inattention Test)
  • Excessive pain in the paretic upper limb (visual analog scale of shoulder pain < 70)

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Hand Rehabilitation Lab — Raleigh

Публикации

  • Connelly L, Jia Y, Toro ML, Stoykov ME, Kenyon RV, Kamper DG. A pneumatic glove and immersive virtual reality environment for hand rehabilitative training after stroke. IEEE Trans Neural Syst Rehabil Eng. 2010 Oct;18(5):551-9. doi: 10.1109/TNSRE.2010.2047588. Epub 2010 Apr 8. PMID 20378482
  • Thielbar KO, Lord TJ, Fischer HC, Lazzaro EC, Barth KC, Stoykov ME, Triandafilou KM, Kamper DG. Training finger individuation with a mechatronic-virtual reality system leads to improved fine motor control post-stroke. J Neuroeng Rehabil. 2014 Dec 26;11:171. doi: 10.1186/1743-0003-11-171. PMID 25542201
  • Shin H, Hu X. Flexibility of Finger Activation Patterns Elicited through Non-invasive Multi-Electrode Nerve Stimulation. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:1428-1431. doi: 10.1109/EMBC.2018.8512479. PMID 30440660

Идентификаторы

NCT: NCT05621980 · 23989 · 22-2459 · 1R21HD105874-01

Первоисточники (государственные реестры)

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