BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

Официальное название

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training

Обзор

The focus of this study is to perform a preliminary assessment of the efficacy of the BurtVision system. While the Burt robotic-arm assists the patient's upper-limb in their movements, BurtVision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games. The investigators will compare clinical outcomes when the BurtVisions ystem is used for training solely relying on unimanual tasks vs. when it is used for training relying on both unimanual and bimanual tasks.

Подробное описание

The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the BurtVistion on motor gains after robot-assisted upper-limb. Study participants (stroke survivors) will be recruited at the Spaulding Rehabilitation Hospital - Boston. Subjects will be randomly assigned to one of the two different groups: unimanual or unimanual + bimanual arm therapy using a block-randomized allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and chronicity, are balanced between groups.

Вмешательства

• Устройство Burt
  18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.
• Устройство Burt + BurtVision
  18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision.

Первичные конечные точки

• Motor Activity Log- Amount of Use [Срок оценки: Data will be collected at baseline and at 7-8 weeks]

Вторичные конечные точки (5)

• Fugl-Meyer Assessment, Upper-Extremity portion [Срок оценки: Data will be collected at baseline and at 7-8 weeks]
• Wolf Motor Function Test [Срок оценки: Data will be collected at baseline and at 7-8 weeks]
• Stroke Impact Scale [Срок оценки: Data will be collected at baseline and at 7-8 weeks]
• Motor Activity Log- Quality of Use [Срок оценки: Data will be collected at baseline and at 7-8 weeks]
• Upper-Extremity Accelerometry [Срок оценки: Data will be collected at baseline and at 7-8 weeks]

Критерии участия

Критерии включения

• Male or female, 18-80 years old;
• Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;
• Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;
• Some active pro-supination range of motion;
• Some active metacarpal-phalangeal joint in the hemiparetic hand;
• Intact cognitive function to understand the robotic therapy procedures (MMSE>23 and able to follow 3 step command) during initial evaluation visit;

Критерии исключения

• Undergoing upper-limb rehabilitation therapy during the period of the study.
• Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;
• Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject's ability to play the interactive games (as assessed with the line bisection test);
• Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;
• Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
• Individuals with open wounds or recent fracture (<3 months) in the upper extremity, fragile skin or active infection;
• Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04940403 · 2021P001807

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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