Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke

Официальное название

Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke

Обзор

This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after intervention.

Подробное описание

Background. The sequence of establishing proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI).

Methods. This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into PRI or DRI groups and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI.

Вмешательства

• Устройство Bi-Manu-Track
  The PRI and DRI protocol provide robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).In every session of robotic training, the patient will practice bilateral passive range of motion exercise, in which affect

Первичные конечные точки

• Fugl-Meyer Assessment [Срок оценки: Fugl-Meyer Assessment will be administered to participants at baseline.]
• Fugl-Meyer Assessment [Срок оценки: Fugl-Meyer Assessment will be administered to participants at immediately after intervention.]
• Fugl-Meyer Assessment [Срок оценки: Fugl-Meyer Assessment will be administered to participants at three months after intervention.]
• Medical Research Council Scale [Срок оценки: Medical Research Council Scale will be administered to participants at baseline.]
• Medical Research Council Scale [Срок оценки: Medical Research Council Scale will be administered to participants immediately after intervention.]
• Medical Research Council Scale [Срок оценки: Medical Research Council Scale will be administered to participants three months after intervention.]

Вторичные конечные точки (12)

• The ABILHAND Questionnaire [Срок оценки: The ABILHAND Questionnaire will be administered to participants at baseline.]
• The ABILHAND Questionnaire [Срок оценки: The ABILHAND Questionnaire will be administered to participants immediately after intervention..]
• The ABILHAND Questionnaire [Срок оценки: The ABILHAND Questionnaire will be administered to participants three months after intervention..]
• The Stoke Impact Scale 3.0 [Срок оценки: The Stoke Impact Scale 3.0 will be administered to participants at baseline.]
• The Stoke Impact Scale 3.0 [Срок оценки: The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.]
• The Stoke Impact Scale 3.0 [Срок оценки: The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.]
• The Stroke Self-Efficacy Questionnaire [Срок оценки: The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.]
• The Stroke Self-Efficacy Questionnaire [Срок оценки: The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.]
• The Stroke Self-Efficacy Questionnaire [Срок оценки: The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.]
• The Wolf Motor Function Test [Срок оценки: The Wolf Motor Function Test will be administered to participants at baseline.]
• The Wolf Motor Function Test [Срок оценки: The Wolf Motor Function Test will be administered to participants immediately after intervention.]
• The Wolf Motor Function Test [Срок оценки: The Wolf Motor Function Test will be administered to participants three months after intervention.]

Критерии участия

Критерии включения

• The inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE motor impairment (i.e., total UE score of the Fugl-Meyer Assessment \[FMA\] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified Ashworth Scale score <3 in any of the affected shoulder, elbow, wrist, and fingers), able to follow instructions (Mini-Mental State Examination total score >24), no UE fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies.

Критерии исключения

• The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 4 центра

• National Taiwan University Hospital — Taipei
• Taipei Tzu Chi Hospital — New Taipei City
• Fongyuan Hospital — Taichung
• Taipei Municipal Wan Fang Hospital — Taipei

Публикации

• Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3. PMID 38433459
• Lee YC, Li YC, Lin KC, Chen CL, Wu YH, Kuo C, Yeh YP, Liu TX. Effects of proximal priority and distal priority robotic priming techniques with impairment-oriented training of upper limb functions in patients with chronic stroke: study protocol for a single-blind, randomized controlled trial. Trials. 2021 Sep 8;22(1):604. doi: 10.1186/s13063-021-05561-6. PMID 34496938

Идентификаторы

NCT: NCT04446273 · 202004105RINB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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