Robot-Assisted Gait Training vs Visual Feedback Balance Training in Stroke

Официальное название

Comparison of Robot-Assisted Gait Training and Visual Feedback Balance Training on Balance and Gait Outcomes in Patients With Stroke

Обзор

Stroke frequently leads to balance impairment and gait dysfunction, increasing fall risk and limiting functional independence. Technology-assisted rehabilitation approaches such as robot-assisted gait training and visual feedback balance training have been shown to improve balance and mobility in stroke patients. This randomized, assessor-blinded clinical trial aims to compare the effects of robot-assisted gait training and visual feedback balance training on balance and gait outcomes in patients with subacute and chronic stroke. Both interventions are part of routine clinical rehabilitation practice. Participants will be evaluated at baseline and after 4 weeks of intervention using clinical balance, gait, and functional assessments.

Подробное описание

Stroke is a leading cause of neurological disability worldwide and is frequently associated with gait disturbances and impaired balance. Approximately 80% of stroke survivors experience walking limitations, and many are at increased risk of falls due to postural instability. Restoring balance and independent ambulation is therefore a primary goal of stroke rehabilitation.

Technology-assisted rehabilitation approaches have been increasingly integrated into clinical practice. Robot-assisted gait training provides repetitive, task-specific, and controlled gait patterns that may enhance motor relearning and postural control. Visual feedback balance training using computerized posturography systems aims to improve weight shifting, postural stability, and dynamic balance through real-time feedback.

Although both interventions have demonstrated beneficial effects when combined with conventional rehabilitation, direct comparisons between these two technology-based approaches under similar treatment dosage conditions are limited.

This prospective, randomized, assessor-blinded clinical trial will compare robot-assisted gait training and visual feedback balance training in subacute and chronic stroke patients receiving inpatient rehabilitation. Both interventions are routinely applied in the clinical setting, and no additional experimental procedures will be introduced.

Participants will receive 4 weeks of intervention. Outcomes will be assessed at baseline and after treatment using the Berg Balance Scale as the primary outcome measure, along with secondary measures including functional mobility, gait speed, motor recovery, fear of falling, functional independence, and posturography-derived balance parameters.

Вмешательства

• Устройство Robot-Assisted Gait Training
  Robot-Assisted Gait Training (RoboGait®) Robot-assisted gait training will be delivered using the RoboGait® device (Bama Technology, METU Technokent, Ankara, Türkiye). The system provides repetitive, task-specific gait training with controlled movement patterns to improve dynamic balance, gait symmetry, and motor relearning. Sessions will be performed twice weekly for 4 weeks, each lasting 30 minutes. Body weight support and gait parameters will be adjusted according to the patient's clinical st
• Устройство Visual Feedback Balance Training
  Visual Feedback Balance Training Visual feedback balance training will be performed using the ProKin 252 system (TecnoBody S.R.L., Bergamo, Italy). The system provides real-time visual feedback to improve postural stability, weight shifting, and dynamic balance control. Sessions will be conducted twice weekly for 4 weeks, each lasting 30 minutes. Training difficulty will be progressively adjusted according to patient performance and safety. Other: Conventional Rehabilitation Program Participant

Первичные конечные точки

• Berg Balance Scale [Срок оценки: Before Treatment]
• Berg Balance Scale [Срок оценки: 4 Week After Treatment]

Вторичные конечные точки (12)

• Timed Up and Go Test [Срок оценки: Before Treatment]
• Timed Up and Go Test [Срок оценки: 4 Week After Treatment]
• 10-Meter Walk Test [Срок оценки: Before Treatment]
• 10-Meter Walk Test [Срок оценки: 4 Week After Treatment]
• Fugl-Meyer Assessment - Lower Extremity [Срок оценки: Before Treatment]
• Fugl-Meyer Assessment - Lower Extremity [Срок оценки: 4 Week After Treatment]
• Barthel Index [Срок оценки: Before Treatment]
• Barthel Index [Срок оценки: 4 Week After Treatment]
• Falls Efficacy Scale - International [Срок оценки: Before Treatment]
• Falls Efficacy Scale-International [Срок оценки: 4 Week After Treatment]
• Functional Ambulation Category [Срок оценки: Before Treatment]
• Functional Ambulation Category [Срок оценки: 4 Week After Treatment]

Критерии участия

Критерии включения

• Age 21-85 years
• Diagnosis of ischemic or hemorrhagic stroke confirmed by clinical and radiological findings
• Functional Ambulation Category (FAC) ≥ 3
• Modified Ashworth Scale ≤ 2 (lower extremity)
• Ability to understand and follow simple verbal instructions
• Mini-Mental State Examination (MMSE) score ≥ 23

Критерии исключения

• Unstable cardiopulmonary conditions
• Severe musculoskeletal disorders affecting standing or walking
• Severe aphasia preventing participation in assessments
• Severe visual impairment interfering with balance testing

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

Turkey (Türkiye) · 1 центр

• AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital — Bolu

Публикации

• Filingeri V, Baroni B, Boffo V, Rosati R, Pisani F, Nardi S, Casciani CU. [Effects of cyclosporin on blood gastrin after kidney transplant]. Minerva Med. 1987 Jun 30;78(12):831-4. Italian. PMID 3299147
• Lu W, Wen M, Li Y, Liu F, Li Y, Zhang H, Zhang M. Effects of visual feedback balance system combined with weight loss training system on balance and walking ability in the early rehabilitation stage of stroke: a randomized controlled exploratory study. Ther Adv Neurol Disord. 2024 Sep 30;17:17562864241266512. doi: 10.1177/17562864241266512. eCollection 2024. PMID 39376636
• Gunduz MS, Mustafaoglu R, Ural IH. Effects of Robot-Assisted Gait Training on Balance and Fear of Falling in Patients With Stroke: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2025 Jun 1;104(6):558-566. doi: 10.1097/PHM.0000000000002674. Epub 2024 Dec 3. PMID 39642346

Идентификаторы

NCT: NCT07471919 · AIBU-FTR-YE-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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