Motor-Cognitive Interactive Upper Limb Robot Rehabilitation for Post-Stroke Motor Dysfunction

Официальное название

Motor-Cognitive Interactive Upper Limb Rehabilitation Robot Intervention for Post-Stroke Motor Dysfunction: A Multicenter Randomized Controlled Study

Обзор

This study aims to investigate the effects of motor-cognitive interactive robot-assisted training on improving upper limb motor dysfunction after stroke. By observing different combinations of motor and cognitive components in the training, the study will clarify the relationship between the proportion of motor and cognitive elements and the recovery of upper limb motor function. The goal is to optimize the training protocol for upper limb rehabilitation robots and enhance their therapeutic outcomes. Participants will be randomly assigned to one of three groups: motor-cognitive interactive robot-assisted training, motor-focused robot-assisted training, or conventional rehabilitation training. Training sessions will last 60 minutes, occur 5 times per week, and continue for 4 weeks. Researchers will measure changes in upper limb function and monitor for any adverse events during the training.

Вмешательства

• Устройство Motor-cognitive interactive robot
  Motor-cognitive interactive robot-assisted training integrates motor and cognitive rehabilitation using an upper limb rehabilitation robot. If patients cannot actively lift the robotic arm, an eye-tracking mode detects movement intention and guides the arm along predefined trajectories, adjusting motor and cognitive loads dynamically. As motor function improves, training shifts to an active mode with increased resistance. Patients complete cognitive tasks before moving the robotic arm, while the
• Устройство Motor-focused robot
  Motor-focused robot-assisted training primarily emphasizes motor rehabilitation through the use of an upper limb rehabilitation robot. When patients are unable to actively lift the robotic arm, an eye-tracking mode is employed to guide movements, with adjustments made solely to the motor load. As motor function improves, the training transitions to an active mode, progressively increasing resistance while maintaining a constant, minimal level of cognitive difficulty. Patients are required to com
• Поведенческое Conventional rehabilitation training
  Conventional rehabilitation training adheres to internationally established guidelines and employs task-oriented approaches tailored to activities of daily living (ADLs). The therapeutic regimen incorporates fundamental motor skill exercises, including but not limited to grasp-and-release maneuvers, targeted reaching, fine motor skill development (e.g., button manipulation, zipper operation), and bilateral coordination tasks (e.g., garment folding, towel wringing). The intervention protocol emph

Первичные конечные точки

• Fugl-Meyer Upper Extremity Scale [Срок оценки: 4 weeks (post-intervention)]

Вторичные конечные точки (9)

• Fugl-Meyer Upper Extremity Scale [Срок оценки: 3 months (post-intervention follow-up)]
• Upper limb kinematics during standardized 3D grid tasks [Срок оценки: 4 weeks]
• Upper Limb Muscle Strength Assessment [Срок оценки: 4 weeks, 3 months]
• Modified Barthel Index [Срок оценки: 4 weeks, 3 months]
• Montreal Cognitive Assessment [Срок оценки: 4 weeks, 3 months]
• Auditory Verbal Learning Test [Срок оценки: 4 weeks, 3 months]
• Trail Making Test Part A [Срок оценки: 4 weeks, 3 months]
• Trail Making Test Part B [Срок оценки: 4 weeks, 3 months]
• Stroke-Specific Quality of Life Scale [Срок оценки: 4 weeks, 3 months]

Критерии участия

Критерии включения

• Diagnosis of stroke confirmed by CT or MRI.
• Age between 40 and 80 years, with no gender restrictions.
• First-ever stroke with unilateral limb paralysis.
• Onset of stroke between 2 weeks and 6 months prior, with an FMA-UE score of 8-44.
• Willingness to participate and provide written informed consent.

Критерии исключения

• History of neuromuscular diseases, malignant tumors, or other severe uncontrolled conditions, including cardiac, renal, or hepatic diseases.
• Seated balance score < 2, or inability to maintain a sitting position for more than 60 minutes.
• Modified Ashworth Scale score > 2.
• Visual Analog Scale (VAS) score > 3 for hemiplegic shoulder pain.
• Boston Diagnostic Aphasia Examination score < 3.
• Severe visual impairment preventing participation in upper limb robot-assisted rehabilitation training.
• Hamilton Depression Scale score >17, indicating moderate to severe depressive symptoms.
• Participation in other clinical trials that may interfere with the results of this study.

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

Китай · 1 центр

• Fujian University of Traditional Chinese Medicine — Фучжоу

Идентификаторы

NCT: NCT06876597 · FujianUTCM-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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