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临床试验/NCT07113093
NCT07113093已完成不适用

Effects of Augmented Reality and Virtual Reality-Assisted Gait Training on Balance and Walking in Individuals With Stroke

Ankara Yildirim Beyazıt University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
Timed Up and Go (TUG) Test

研究概览

简要总结

This randomized controlled trial aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, within the framework of the International Classification of Functioning, Disability and Health (ICF). A total of 66 post-stroke patients will be randomly assigned to three groups: (1) VR group receiving gait training via C-Mill VR applications in addition to conventional physiotherapy, (2) AR group receiving gait training via C-Mill AR applications in addition to conventional physiotherapy, and (3) control group receiving a home exercise program alongside conventional physiotherapy. Participants will train for 45 minutes per day, five days a week, for three weeks. Outcome measures will include clinical, functional, cognitive, and spatiotemporal gait parameters to evaluate changes in balance and walking ability before and after the intervention.

详细描述

This prospective, randomized controlled study aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, and to contribute to the literature through a comprehensive analysis within the International Classification of Functioning, Disability and Health (ICF) framework. Stroke is a leading cause of long-term disability and care burden, with nearly one-third of acute stroke survivors unable to walk three months after onset. Improving walking ability is a central goal of stroke rehabilitation. There is increasing evidence that high-intensity, task-specific, and repetitive training can enhance functional recovery. Treadmill training enables intensive, repetitive practice of complex gait patterns and has been shown to improve walking speed and distance in stroke survivors. Technological advances have introduced immersive tools such as VR and AR systems into rehabilitation, providing engaging and interactive environments that enhance motor learning and patient motivation.

The C-Mill VR+ system (Motek, Netherlands) is a treadmill equipped with both AR and VR applications, offering visual-auditory feedback, safety harnesses, and force sensors. Though studies suggest C-Mill training improves gait and reduces fall risk in geriatric and Parkinson's disease populations, comprehensive randomized controlled trials comparing AR- and VR-supported treadmill training in stroke rehabilitation are lacking.

This study will enroll 66 individuals with stroke undergoing inpatient rehabilitation at the Virtual Reality Laboratory of Ankara Bilkent City Hospital. Inclusion criteria include diagnosis of hemiplegia (ICD-10 code G81), age 18 or older, and ability to walk with or without assistance (Functional Ambulation Classification ≥ 2). Exclusion criteria include aphasia, MoCA score <10, additional neurological/orthopedic problems, recurrent stroke, or a Modified Ashworth Scale (MAS) score of 3-4 in the lower extremities. Participants will be randomly assigned to one of three groups: (1) VR group-C-Mill VR treadmill training with Nature Island, Italian Apps, and Soccer applications; (2) AR group-C-Mill AR training using Stepping Stones, Reactive Stones, Obstacles, Speed Adjustment, Slalom, Tandem, and Monster Game applications; (3) Control group-home-based walking exercises (flat ground, variable step length, obstacles, and speed) in addition to standard physiotherapy. All groups will continue routine physiotherapy and receive 45-minute training sessions, five days a week for three weeks.

Outcome measures assessed pre- and post-intervention include the Timed Up and Go Test, Fugl-Meyer Lower Extremity Motor Assessment, Modified Ashworth Scale, Activities-specific Balance Confidence Scale, Berg Balance Scale, Functional Ambulation Classification, Trunk Impairment Scale, Stroke Impact Scale (3.0), Stroke-Specific Quality of Life Scale, Montreal Cognitive Assessment (MoCA), and spatiotemporal gait analysis via the C-Mill VR+ system. Gait analysis will record step lengths, stance and swing phases, and double support percentages for both paretic and non-paretic limbs at self-selected and fixed speeds.

研究设计

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

入排标准

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

入选标准

  • ICD-10 diagnosis code of G.81 (Hemiplegia)
  • Age 18 years or older
  • Ability to walk with assistance or independently (Functional Ambulation Classification score of 2 or higher)

排除标准

  • Incomplete completion of the assessment form
  • Refusal to participate in the study
  • Montreal Cognitive Assessment score below 10
  • Presence of extra neurological or orthopedic problems unrelated to stroke
  • Recurrent stroke
  • MAS score of 3-4 (lower extremity)
  • Volunteer's desire to withdraw from the study
  • Inability to adapt to the technological devices used in the study (e.g., visual or hearing impairments)
  • Missing three consecutive treatment sessions
  • Botulinum toxin-A (BONT-A) injection to the lower extremity during the treatment process or within the last 6 months

研究组 & 干预措施

Control Group

Other

Participants in this group will be enrolled in a self-directed exercise program that is matched in duration and content to the VR-AR interventions.

干预措施: Self Directed Exercises (Other)

Augmented Reality

Experimental

In this group, augmented reality will be used during treadmill walking.

干预措施: Augmented Reality (Other)

Virtual Reality

Experimental

In this group, virtual reality will be used during treadmill walking.

干预措施: Virtual Reality (Other)

Virtual Reality

Experimental

In this group, virtual reality will be used during treadmill walking.

干预措施: Others (Other)

Control Group

Other

Participants in this group will be enrolled in a self-directed exercise program that is matched in duration and content to the VR-AR interventions.

干预措施: Others (Other)

Augmented Reality

Experimental

In this group, augmented reality will be used during treadmill walking.

干预措施: Others (Other)

结局指标

主要结局

Timed Up and Go (TUG) Test

时间窗: baseline and after 3 weeks

To perform the test, the patient stands up from a chair approximately 46 cm in height, walks at a comfortable and safe pace to a marked target three meters away, turns around the target, and returns to sit back down on the chair. To ensure familiarity with the procedure, the patient performs one trial without timing. If needed, the patient may use their usual walking aid (e.g., cane or walker). A shorter completion time indicates better performance.

Gait Analsis

时间窗: baseline and after 3 weeks

Spatio-temporal gait analysis will be performed using the C-Mill VR+ device. As a result of this measurement, step lengths, stance phases (%), swing phases (%), and double support phases (%) of the paretic and non-paretic limbs will be recorded. Gait analysis will be conducted in two separate assessments: at the participant's self-selected comfortable walking speed and at a fixed speed of 1 km/h. The gait analysis will begin after a 2-minute warm-up period, and data will be collected for the following 2 minutes. A rest period of at least 5 minutes will be provided between the two assessments.

Berg Balance Scale (BBS)

时间窗: baseline and after 3 weeks

The scale consists of 14 items and assesses the patient's ability to maintain balance (either static or during various functional movements) over a specific period of time. Each item is scored on a scale from 0 to 4: 0 points: Unable to complete the task. 4 points: Completes the task independently. The maximum total score is 56. A score of 0-20 indicates poor balance, 21-40 indicates acceptable balance, and 41-56 indicates good balance.

次要结局

  • Fugl-Meyer Motor Assessment Lower Extremity (FMA-LE)(baseline and after 3 weeks)
  • Activities-specific Balance Confidence (ABC) Scale(baseline and after 3 weeks)
  • Functional Ambulation Category (FAC)(baseline and after 3 weeks)
  • Trunk Impairment Scale (TIS)(baseline and after 3 weeks)
  • Stroke Impact Scale (SIS) Version 3.0(baseline and after 3 weeks)
  • Stroke-Specific Quality of Life Scale (SS-QOL)(baseline and after 3 weeks)

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat Akıncı

Principal Investigator

Ankara Yildirim Beyazıt University

研究点 (2)

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