Идёт набор NCT03980457

Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke

Без фазы С лечением Stroke Weakness of Extremities as Sequela of 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: Indego Exoskeleton, Standard Rehabilitation.
Кому может быть актуально: Состояния в реестре: Stroke, Weakness of Extremities as Sequela of Stroke. Базовые параметры: 18 лет — 90 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 goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.

Подробное описание

Abstract

Objective: The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.

Background:

Method: The investigators will study 50 patients with stroke consecutively admitted to a designated stroke rehabilitation unit in the Oklahoma City VA Medical Center. All patients will receive their daily 3-hours conventional therapy, plus an hour of either exoskeleton or over-ground gait training 3 times per week for 60 minutes. Patients were assigned to either the experimental (exoskeleton) or the control (over-ground) groups by computer-generated randomization. This is an open-label pragmatic trial, where neither the patients nor the clinicians could be masked to the intervention. Institution review board (IRB) approval will be obtained for the protocol. The demographic data to be collected includes: age, gender, race/ethnicity, stroke onset to admission, stroke types (ischemic/hemorrhagic), and stroke severity (on the National Institute of Health Stroke Severity \[NIHSS\] scale. Admission and discharge total Functional Independence Measure (FIM), spasticity and depression scores, ambulation velocity over 2-minutes (2-MWT) in feet/minute, and discharge disposition. The intervention is Indego® exoskeleton. The primary outcome measures were: changes in the FIM, depression and spasticity scores. The secondary outcome measure was discharge disposition. Continuous variables were analyzed using Students t-test, ordinal variables were analyzed using Mann-Whitney, and the nominal variables were analyzed using Chi-square analyses.

Вмешательства

Устройство Indego Exoskeleton
Powered generated orthosis
Другое Standard Rehabilitation
Standard Rehabilitation

Первичные конечные точки

The Functional Independence Measure (FIM™) [Срок оценки: Baseline (Day 1) and at 4-weeks to measure change]
The two minute walk test (2-MWT) [Срок оценки: Baseline (Day 1) and at 4-weeks to measure change]

Вторичные конечные точки (3)

Modified Ashworth Scale (MAS) [Срок оценки: Baseline (Day 1) and at 4-weeks to measure change]
Discharge disposition [Срок оценки: 4-weeks]
The Beck Depression Inventory (BDI) [Срок оценки: Baseline (Day 1) and at 4-weeks to measure change]

Критерии участия

Критерии включения

All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging.
Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
Depressed patients will be included in the study
Patients able to stand alone
Patients able to provide a written informed consent, from cognitively intact patients (admission Mini Mental Scale Examination \[MMSE\] greater than or equal to 21).