A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors

Официальное название

A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Subacute Stroke Survivors

Обзор

The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in subacute stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).

Подробное описание

The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in subacute stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).

Study participants will be asked to take part in 4 evaluation study visits: one screening and enrollment visit, and three evaluation visits (at baseline, at 3 months and at 6 months - at the intervention completion). Subject upper-extremity motor function will be assessed across domains of the International Classification of Functioning, Disability and Health (ICF) model. Groups will be stratified by baseline motor impairment and stroke chronicity.

Subjects randomized to the intervention group will take part of weekly coaching sessions during the first month, bi-weekly sessions during the months 2 and 3, and monthly sessions during months 4-6. These sessions will be held in-person or remotely, based on the study participant preference.

Subjects randomized to the control group will take part of monthly visits, held in-person or remotely (based on study participant preference), to re-evaluate the home-exercise plan and prescribe an update list of exercises for the following month.

Вмешательства

• Поведенческое StrokeWear Behavioral Intervention
  Behavioral strategies will be incorporated into the Strokewear system to encourage feedback on behavior, goal setting, daily activity action planning (DAAP), and an empowerment/ self management model to foster planned hemiparetic UE use during daily activities in the home and community. Patient empowerment in this study will occur over 6-months as patients gain the ability to use the StrokeWear technology independently and develop skills to self- manage their GDM and DAAP.
• Другое Usual Care + Sham
  The intervention will consist in a sham version of the StrokeWear system and usual clinical care under the direction of a clinician. The sham version of the StrokeWear system will include sensing and recording technology to detect GDMs. However, study participants will not receive feedback from the system regarding the GDM counts.

Первичные конечные точки

• Change in Motor Activity Log-Amount of Use [Срок оценки: Change from baseline Motor Activity Log-Amount of Use score at 6 months]
• Change in Fugl-Meyer Upper-Extremity [Срок оценки: Change from baseline Fugl-Meyer Upper-Extremity score at 6 months]
• Change in Upper-Extremity Activity Counts [Срок оценки: Change from baseline Upper-Extremity Activity Counts score at 6 months]

Вторичные конечные точки (6)

• Change in Motor Activity Log-Quality of Use [Срок оценки: Change from baseline Motor Activity Log-Quality of Use score at 6 months]
• Change in Wolf-Motor Function Test - Time subscale [Срок оценки: Change from baseline Wolf-Motor Function Test - Time subscale score at 6 months]
• Change in Wolf-Motor Function Test - Functional ability subscale [Срок оценки: Change from baseline Wolf-Motor Function Test - Functional ability subscale score at 6 months]
• Change in Stroke Impact Scale (SIS) [Срок оценки: Change from baseline Stroke Impact Scale (SIS) score at 6 months]
• Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale [Срок оценки: Change from baseline Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale score at 6 months]
• Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Self-management subscale [Срок оценки: Change from baseline Self-Efficacy Questionnaire (SSEQ) - Self-management subscale score at 6 months]

Критерии участия

Критерии включения

• Male or female, 18-85 years of age at the time of enrollment
• Anterior circulation ischemic stroke at least 1 month and no more than 6 months prior to study enrollment;
• Unilateral upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 20 and 45;
• Intact cognitive function to understand the study procedures and goal setting (MMSE score above 23 and able to follow 3step command) ;
• Owning a smartphone (iOS or Android) and being familiar and comfortable with and owning a tablet or smartphone
• SAFE score equal or greater than 5

Критерии исключения

• Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks;
• 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 ability to see the feedback on the app screen (as assessed with the Mesulum cancellation test);
• Individuals with open wounds or recent fracture (less than 3 months) in the upper extremity, fragile skin or active infection;
• Upper-extremity orthopedic injuries or severe pain resulting in movement limitations;
• Diagnosis of other neurological disease; (i.e., Parkinson's disease, multiple sclerosis, ...);
• Severe proprioceptive deficits that impair the ability to process the vibration feedback, as assessed by physical examination during screening;
• Not understanding spoken or written English;
• Contralateral motor deficits as assessed by clinical examination;
• Brainstem and cerebellar stroke.

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

США · 1 центр

• Spaulding Rehabilitation Hospital — Boston

Идентификаторы

NCT: NCT06797154 · 2024P003622 · R44HD084035

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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