Effects on Subacute Stroke With Robotic Assistive Gait Training

Официальное название

The Effectiveness of Subacute Stroke Patients Receiving Robotic Assisted Gait Training

Обзор

The goal of this randomized controlled trial is to learn about the effects of Robotic Assisted Gait Training (RAGT) combined with traditional physical therapy in subacute stroke patients. The main question it aims to answer is: \- Does RAGT combined with traditional physical therapy improve gait and functional performance in subacute stroke patients compared to traditional physical therapy alone? Participants who are subacute stroke patients will be randomly assigned to receive either both RAGT and traditional physical therapy or only traditional physical therapy. Their gait and functional performance will be assessed during the study period.

Подробное описание

The sequelae of stroke have a significant impact on patients' physical functions and quality of life. Although traditional physical therapy can help some patients regain function, its effectiveness is often limited. Therefore, exploring new rehabilitation technologies has become one of the key tasks in the medical field. Robotic Assisted Gait Training (RAGT) is an emerging technology that provides high-intensity and repetitive gait training, making it particularly suitable for patients in the post-stroke rehabilitation phase. Recent studies have shown that RAGT can significantly improve gait abilities in stroke patients, including walking speed and functional performance. Therefore, this study will adopt a randomized controlled trial design, recruiting 20 subacute stroke patients who will be randomly assigned to either a group receiving both RAGT and traditional physical therapy or a group receiving only traditional physical therapy. The study will compare differences in gait and functional performance between the two groups during the rehabilitation process, aiming to provide a foundation for future personalized and precision treatment plans.

Вмешательства

• Устройство Freewalk lower limb Robotic Assistive Gait Training
  Participants in this group will receive robotic-assisted gait training three times per week (every other day) for 30 minutes per session, using the FREE Walk exoskeleton device (FREE Bionics, Taiwan). The device assists with walking, standing, and sitting. A physical therapist will help the participant wear the exoskeleton and supervise the training, adjusting the level of robotic support and intensity based on the participant's ability. In addition to RAGT, participants will receive conventiona
• Другое Physiotherapy
  Participants in this group will receive conventional stroke rehabilitation therapy (including sit to stand, balance and gait training) 5 days/week, 30 minutes per session. Intervention Duration: 4 weeks.

Первичные конечные точки

• Gait Speed [Срок оценки: Baseline and after 4 weeks of intervention]
• Step Length [Срок оценки: Baseline and after 4 weeks of intervention]
• Toe Clearance [Срок оценки: Baseline and after 4 weeks of intervention]
• Timed Up and Go Test (TUG) [Срок оценки: Baseline and after 4 weeks of intervention]
• Functional Independence Measure (FIM) [Срок оценки: Baseline and after 4 weeks of intervention]

Вторичные конечные точки (4)

• Berg Balance Scale (BBS) [Срок оценки: Baseline and after 4 weeks of intervention]
• 30-Second Chair Stand Test (30-CST) [Срок оценки: Baseline and after 4 weeks of intervention]
• Surface Electromyography (sEMG) [Срок оценки: Baseline and after 4 weeks of intervention]
• Short Form-12 Health Survey (SF-12) [Срок оценки: Baseline and after 4 weeks of intervention]

Критерии участия

Критерии включения

• Diagnosed with stroke (ischemic or hemorrhagic) confirmed by medical imaging.
• Subacute phase of stroke (onset within 1 to 3 months).
• Moderate to good standing balance ability.
• Sufficient cognitive ability to understand the study and follow instructions.
• Able to participate in rehabilitation training during the study period.

Критерии исключения

• Body weight over 90 kg.
• Presence of other neurological disorders.
• Severe cardiovascular disease or other health conditions affecting mobility.
• Significant lower limb pain, joint contracture, or spasticity (Modified Ashworth Scale score > 3) that impairs walking.
• Diagnosed with cardiopulmonary disease that contraindicates exercise training.
• Cognitive impairment that prevents understanding of training instructions or completion of questionnaires.
• Inability to complete the rehabilitation training protocol.

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

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Changhua Christian Hospital — Changhua

Идентификаторы

NCT: NCT07040215 · 250321

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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