A Comparison of the Effects of Virtual Reality-Based Balance Training and Robot-Assisted Gait Training on Balance and Gait Performance in Individuals with Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Berg Balance Scale
研究概览
简要总结
The aim of research is to examine and compare the effectiveness of virtual reality-based balance training and robot-assisted walking approaches on balance and gait in individuals post-stroke. Through the study, Investigators intend to reach conclusions regarding whether the focus should be on balance or walking training based on the Berg Balance Scale and Functional Ambulation Classification levels of stroke survivors. Subgroups will be formed in both groups based on Functional Ambulation and Berg Balance Scale scores. The balance and gait developments within these subgroups will be compared, aiming to determine at which levels balance or walking improvement is more pronounced. These findings are crucial for making the right choices in setting rehabilitation goals for individual patients.
详细描述
Stroke is one of the leading causes of death in adults and results in severe disability. Within the first 3 months after a stroke, 20% of patients use a wheelchair, and 70% experience walking problems. Balance problems are among the most common issues after a stroke, impacting a patient's ability to sit, stand, transfer, and walk, thereby creating a risk of falls. Additionally, balance and walking quality are vital components, with abnormalities potentially leading to abnormal walking patterns, reduced walking speed, and spatiotemporal asymmetries. Therefore, improving balance and walking is a fundamental goal in stroke rehabilitation and holds priority for many patients and their families.
Robot-assisted gait training (RAGT) is an emerging and promising technological approach in stroke rehabilitation. RAGT provides safe, high-intensity, and task-oriented walking training with ample repetitions. Repetitive tasks can enhance neuroplasticity and motor learning, resulting in improved balance and walking speed.
Robotic systems come in two types: end-effector and exoskeleton. The Lokomat® FreeD (Hocoma AG, Switzerland) is an exoskeleton-type robot. Unlike the conventional Lokomat, the FreeD module allows pelvic translation to the right and left, along with rotation. These coordinated pelvic movements are mechanically facilitated by the device during walking. It is known that these movements are crucial for human walking and balance, and with the FreeD module, these pelvic movements have become part of robot-assisted gait training.
In a systematic review comparing Lokomat with conventional physiotherapy, it was reported that Lokomat is equally effective in terms of balance. Another review found that patients undergoing robot-assisted gait training showed better improvement in balance compared to those not receiving this treatment. The literature supports Lokomat's positive effects on both balance and walking.
In this research, virtual reality applications on Lokomat® will be integrated as part of the exercises in the Lokomat group and virtual reality-based balance training using the Balance Trainer will be employed for the Balance-Trainer group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having the ICD-10 diagnosis code G.81 Hemiplegia
- •At least 3 weeks having passed since the diagnosis (Subacute and cronic periods)
- •Being 18 years of age or older
- •Having a Berg Balance Score between 21-40 (indicating an acceptable balance)
- •Being able to walk with or without support (FAC score of 2 or higher)
排除标准
- •Having a known additional neurological or orthopedic problem that could affect balance
- •Inability to adapt to virtual reality applications in Lokomat and Balance Trainer
- •Diagnosis being more than 2 years old
结局指标
主要结局
Berg Balance Scale
时间窗: Baseline and After last treatment seasion
This is a simple and safe balance test designed to measure an individual's ability to maintain balance while performing functional tasks. The person is asked to perform 14 tasks, and scores are given based on the completion of each task. A score of 0 is assigned when the activity is not performed at all, while a score of 4 is given when the activity is completed independently. The highest possible score is 56, with 0-20 indicating balance impairment, 21-40 suggesting an acceptable balance, and 41-56 indicating good balance.
Spatiotemporal Gait Analysis
时间窗: Baseline and After last treatment seasion
In our research, spatiotemporal gait analysis will be conducted using the CMill VR+ device. As a result of gait analysis, parameters such as step lengths, swing, stance and double support phases, cadence, and levels of weight shifting to each side during walking will be recorded.
次要结局
- Functional Independence Measure(Baseline and After last treatment seasion)
- Functional Ambulation Category(Baseline and After last treatment seasion)
研究者
Murat Akıncı
Principal Investigator
Ankara Yildirim Beyazıt University