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临床试验/NCT06557681
NCT06557681进行中(未招募)不适用

The Effect of Virtual Reality Treadmill-Based Gait Training on Gait and Balance Ability in Chronic Stroke Patients

Yonsei University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2024年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Time Up and Go (TUG)

研究概览

简要总结

Walking independence is one of the most important goals for stroke patients and a major factor influencing their return to society after the onset of stroke. Stroke patients experience walking difficulties due to hemiplegia and have an increased risk of falls due to impaired balance ability. Recent studies have shown that treadmill-based walking training incorporating virtual reality can help improve walking and balance functions in actual stroke patients. However, there are few randomized clinical trials with control groups, highlighting the need for further research to ensure the reliability of clinical effects.

Therefore, this study aims to investigate the impact of treadmill-based training incorporating virtual reality on walking and balance functions. The training equipment to be used is the C-mill VR+ device, which enables walking training and assessment, balance training and assessment, and obstacle training using a front screen and treadmill videos. The investigators intend to thoroughly examine the walking ability and balance ability of the subjects obtained through this equipment, along with various evaluation tools.

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
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 19 years or older.
  • Confirmed diagnosis of stroke by a neurologist or neurosurgeon through radiological methods such as CT or MRI.
  • Chronic hemiplegic stroke patients, six months post-stroke onset.
  • Patients with a Functional Ambulatory Category score of 3 or higher.
  • Patients with a Mini-Mental State Examination (MMSE) score of 10 or higher, who understand the study, are willing to participate voluntarily, and have given consent to participate.

排除标准

  • Acute/subacute stroke patients within six months of stroke symptom onset.
  • Patients with quadriplegia.
  • Patients with ataxia.
  • Patients with severe joint contracture of the lower limbs that makes wearing orthotics difficult.
  • Patients with neurological, musculoskeletal, or cardiopulmonary diseases that affect walking.
  • Any other cases deemed inappropriate for participation by the researcher.

结局指标

主要结局

Time Up and Go (TUG)

时间窗: Baseline (Pre-intervention) and immediately after intervention completion (6 weeks after intervention start)

The Timed Up and Go (TUG) test is a simple and reliable assessment used to evaluate a patient's mobility and balance abilities. During the test, the patient starts seated in a chair, then stands up, walks 3 meters to a designated marker, turns around, walks back to the chair, and sits down. The time taken to complete this sequence is measured. Shorter completion times indicate better mobility and balance. The TUG test is widely used to assess walking ability and fall risk in various conditions, including stroke and geriatric disorders.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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