Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

Официальное название

Sensor Enhanced Activity Motivation After Stroke

Обзор

The goal of this study is to determine the effectiveness of behavioral support and feedback from a wearable device that senses arm movement in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients

Подробное описание

In this randomized controlled trial, the investigators will evaluate two telerehabilitation strategies for increasing arm use at home: a smartwatch app and a psychological intervention. The psychological intervention aims to address ambivalence and enhance motivation, while the smartwatch provides feedback on arm movement variability. The investigators hypothesize that combining the psychological intervention with smartwatch feedback will lead to greater improvements in arm use and upper extremity recovery

Вмешательства

• Другое Smartwatch App for Movement Variability
  This app measures movement variability in the upper extremity as described in our previous study (doi:10.3390/s24165266).
• Другое Smartwatch App for Active Time
  The other software we are using measures total active time of the upper extremity.
• Поведенческое Motivational Interviewing (Within Subjects)
  Motivational Interviewing is an established therapeutic technique designed to increase patient adherence to therapy by addressing ambivalence. The motivational Interviewing sessions will include a variety of techniques such as: Open ended questions, Active Listening, Affirmation, Summarization, Questions focused on change talk, and Providing Information.

Первичные конечные точки

• Variability Measurement [Срок оценки: From enrollment to the end of treatment and follow up measurement (9 weeks)]

Вторичные конечные точки (10)

• Active Time [Срок оценки: From enrollment to the end of treatment and follow up measurement (9 weeks)]
• Fugl-Meyer Arm Motor Assessment [Срок оценки: Initial Visit, First follow up, Second follow up]
• Box and Blocks Test [Срок оценки: Initial Visit, First follow up, second follow up]
• Nine Hole Peg Test [Срок оценки: Initial Visit, First follow up, Second follow up]
• Motor Activity Log (MAL) [Срок оценки: Initial Visit, First follow up, Second follow up]
• Open Point [Срок оценки: Initial Visit, First follow up, Second follow up]
• NIH Stroke Scale [Срок оценки: Initial Visit, First follow up, Second follow up]
• Fatigue Severity Scale (FSS) [Срок оценки: Initial Visit, First follow up, Second follow up]
• Fugl-Meyer Sensory Assessment: Touch and Proprioception [Срок оценки: Initial Visit, First follow up, Second follow up]
• Kinect: Sensor-based Upper Extremity Reachable Workspace Evaluation [Срок оценки: Initial Visit, First follow up, Second follow up]

Критерии участия

Критерии включения

• 18 to 85 years of age
• Experienced a single or multiple, ischemic or hemorrhagic stroke, with unilateral weakness, over six months previously
• An ability to score at least 3 blocks on the Box and Block Test. BBT score of the affected arm is at least 5% worse than that present with the unaffected arm.
• Absence of major depression, as defined by DSM V criteria or a score on the Geriatric Depression Scale < 10.

Критерии исключения

• Any substantial decrease in alertness, language reception, or attention
• Single or multiple, ischemic or hemorrhagic stroke less than 6 months ago
• Severe muscle tone at the upper extremity (score ≥ 3 on the Modified Ashworth Spasticity scale)
• Pregnant or lactating
• Advanced liver, kidney, cardiac, or pulmonary disease
• Coexistent major neurological disease
• Coexistent major psychiatric disease
• Plans to alter any current participation in other rehabilitation therapy in the time period of the study
• A terminal medical diagnosis consistent with survival < 1 year
• A history of significant alcohol or drug abuse in the prior 3 years
• Current enrollment in another study related to stroke or stroke recovery
• Any other medical contraindication to participation in the study, as evaluated by our team physician.
• Visual Analog of Pain Scale Score of 7 or greater

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

• University of California Irvine — Irvine

Публикации

• Schwerz de Lucena D, Rowe JB, Okita S, Chan V, Cramer SC, Reinkensmeyer DJ. Providing Real-Time Wearable Feedback to Increase Hand Use after Stroke: A Randomized, Controlled Trial. Sensors (Basel). 2022 Sep 14;22(18):6938. doi: 10.3390/s22186938. PMID 36146287

Идентификаторы

NCT: NCT07042152 · 2621

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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