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临床试验/NCT07471919
NCT07471919招募中不适用

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

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Berg Balance Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Visual Feedback Balance Training Group

Active Comparator

Visual Feedback Balance Training Conventional Rehabilitation Program

干预措施: Visual Feedback Balance Training (Device)

Robot-Assisted Gait Training Group

Active Comparator

Robot-Assisted Gait Training Conventional Rehabilitation Program

干预措施: Robot-Assisted Gait Training (Device)

结局指标

主要结局

Berg Balance Scale

时间窗: Before Treatment

The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning.

Berg Balance Scale

时间窗: 4 Week After Treatment

The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning.

次要结局

  • Timed Up and Go Test(Before Treatment)
  • Timed Up and Go Test(4 Week After Treatment)
  • 10-Meter Walk Test(Before Treatment)
  • 10-Meter Walk Test(4 Week After Treatment)
  • Fugl-Meyer Assessment - Lower Extremity(Before Treatment)
  • Fugl-Meyer Assessment - Lower Extremity(4 Week After Treatment)
  • Barthel Index(Before Treatment)
  • Barthel Index(4 Week After Treatment)
  • Falls Efficacy Scale - International(Before Treatment)
  • Falls Efficacy Scale-International(4 Week After Treatment)
  • Functional Ambulation Category(Before Treatment)
  • Functional Ambulation Category(4 Week After Treatment)
  • Center of Pressure Standard Deviation(Before Treatment)
  • Center of Pressure Standard Deviation(4 Week After Treatment)
  • Center of Pressure Ellipse Area(Before Treatment)
  • Center of Pressure Ellipse Area(4 Week After Treatment)
  • Total Sway Perimeter(Before treatment)
  • Total Sway Perimeter(4 Week After Treatment)
  • Dynamic Balance (Average Track Error)(Before treatment)
  • Dynamic Balance (Average Track Error)(4 Week After Treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yakup Erden, MD

Physical Medicine and Rehabilitation Physician

Abant Izzet Baysal University

研究点 (1)

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