Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
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: MyoTrain, Motor Imagery.
- Кому может быть актуально
- Состояния в реестре: Amputation, Upper Limb. 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Regulatory Clearance of a Rehabilitation System for Individuals With Upper Limb Loss
Обзор
The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days. These individuals will be randomized to Group A (Control Group using standard motor imagery training) and Group B (who are provided the MyoTrain system). The investigators will test three hypotheses: 1. The use of MyoTrain results in skills transference to control of the final prosthesis 2. The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures 3. The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo clinical assessment. Post-device delivery, participants will then complete 3 56-day blocks of at-home prosthesis use, in between which they will return to clinic for assessment.
Вмешательства
- Устройство MyoTrain
MyoTrain is a virtual prosthesis control training system. From a hardware perspective it consists of an Apple iPad tablet computer and an eight-channel EMG armband, based on the Element electrode platform, which interfaces with the tablet via Bluetooth™. From a software perspective, MyoTrain was developed in the cross-platform Unity 4.0 game development environment. - Поведенческое Motor Imagery
Motor imagery describes the process by which a prosthesis user mentally simulates the execution of a desired limb movement and activates the musculature of the residual limb that would generate the desired movement.
Первичные конечные точки
- Mean Prosthesis Wear Duration [Срок оценки: Days 35-206]
Вторичные конечные точки (5)
- Assessment of Capacity for Myoelectric Control (ACMC) [Срок оценки: Days 31, 35, 93, 149, and 206]
- Clothespin Relocation Test (CRT) [Срок оценки: Days 31, 35, 93, 149, and 206]
- Module 2 of MyoTrain [Срок оценки: Days 0, 31, 35, 93, 149, and 206]
- Patient-Reported Outcomes Measurement Information System (PROMIS) [Срок оценки: Days 0, 31, 35, 93, 149, and 206]
- Daily Mean Number of Movement Bouts [Срок оценки: Days 35-206]
Критерии участия
Критерии включения
- Trans-radial unilateral limb loss
- Candidate for a 2+ degree-of-freedom myoelectric pattern recognition prosthesis as determined by prosthetist
- Fluent in English
- Age of 18 years or greater
Критерии исключения
- Prior experience with pattern recognition control
- Patients with a residual limb that is unhealed from the amputation surgery
- Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
- Unhealed wounds
- Significant cognitive deficits as determined upon clinical evaluation
- Significant neurological deficits as determined upon clinical evaluation
- Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- Uncontrolled pain or phantom pain impactive full participation in the study as determined upon clinical evaluation
- Serious uncontrolled medical problems as judged by the project therapist
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
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Hanger Clinic - Grand Rapids — Grand Rapids
Идентификаторы
NCT: NCT05888428 · U44NS119842