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Investigating the Impact of Treadmill-integrated Virtual Reality Training on Walking Outside the Clinic

2026年11月9日 更新者:Shepherd Center, Atlanta GA

Investigating the Acute and Long-term Effects of Treadmill-integrated Virtual Reality (VR) Training on Real-World Mobility and Fall-Related Outcomes in People With Multiple Sclerosis

This study will test whether a treadmill-based virtual reality walking program is safe, practical, and helpful for people with multiple sclerosis (MS). Participants will complete a 6-week training program and wear smart socks that measure how they walk before, during, and after the program. The study will also track changes in balance, fatigue, fall risk, fear of falling, confidence with walking, and overall quality of life.

研究概览

详细说明

People with multiple sclerosis (MS) often have trouble with walking and balance, which can increase the risk of falls and make daily life harder. While therapy can improve walking in a clinic, it is not always clear if those improvements carry over to real life at home or in the community. In addition, most walking tests are done over short periods and may not show how a person moves throughout the day. This study will look at new ways to better understand and improve walking in everyday settings. Researchers will use a treadmill-based virtual reality program, along with smart socks that track walking during daily activities. This approach will help show how people respond to training and whether those changes last outside the clinic. Standard care for people with MS usually includes physical therapy and clinic-based walking tests, but these may miss important changes in daily movement.

Participants will be asked to provide basic health information and complete surveys about their walking, fatigue, balance, thinking, and quality of life at different times during the study. They will also complete simple walking and balance tests to measure their mobility. As part of the study, participants will take part in a 6-week treadmill-based virtual reality training program, with two sessions each week. During the study, they will wear smart socks that collect information about how they walk in their daily lives, including before, during, and after the training program. These socks will track how often they walk, how steady they are, and how their walking changes over time. After the training ends, participants will continue wearing the socks for several weeks so researchers can see if improvements last. The results will help researchers learn if this approach can improve walking, lower fall risk, and support better mobility and quality of life for people living with MS.

研究类型

介入性

注册 (估计的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Georgia
      • Atlanta、Georgia、美国、30309
        • 招聘中
        • Shepherd Center
        • 接触:
        • 首席研究员:
          • Julie F Stowell, DPT

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Have a clinically confirmed diagnosis of multiple sclerosis (MS).
  • Be 18 years of age or older.
  • Demonstrate ≥10% variability in stride length, step length, or gait asymmetry.
  • Can ambulate without an assistive device, with a unilateral, or with a bilateral assistive device.
  • Demonstrate no more than mild cognitive impairment, indicated by the Mini-Mental State Exam (score >19).
  • Possess adequate cognitive function to understand and follow research instructions.
  • Be able to safely participate in the study and training procedures as determined by study staff.
  • Be fluent in English and able to communicate discomfort, fatigue, or pain in English.
  • Be able to travel to Shepherd Center to complete key assessment points in-person and for in-person training sessions twice per week.

Exclusion Criteria:

  • Have a diagnosis of any other neurological condition or recent orthopedic conditions that affects gait, balance, or mobility.
  • Exhibit <10% variability in stride length, step length, or gait asymmetry.
  • Are unable to ambulate (i.e. wheelchair bound or bedbound individuals).
  • Have legal blindness or severe visual impairment that would interfere with virtual reality engagement or safe ambulation.
  • Have a body weight exceeding 300 lbs., which exceeds the safety limits of the treadmill and body weight support system.
  • Have uncontrolled or untreated hypertension, hypotension, or angina.
  • Have a past or current history of epilepsy or any other type of seizure disorder, whether controlled or uncontrolled.
  • Have undergone major surgery within the past 6 months or hospitalization within the past 3 months.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Arm 1

Gait training

6-week training program with 2 training sessions each week

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

step length (m)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

stride length (m)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

step time (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

single support time (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

double support time (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

gait cycle (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

cadence (steps/s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

stance time (s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

speed(m/s)

Initial visit to the end of the program in 12 weeks
Spatiotemporal metrics of gait
大体时间:Initial visit to the end of the program in 12 weeks

swing time (s)

Initial visit to the end of the program in 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Fear of falling (FOF)
大体时间:Surveys will be conducted at the initial visit, week 2, 5, 8, and 12.

FOF as determined by Falls Efficacy Scale-International (FES-I); Scale: Not at all concerned = 1, Somewhat concerned = 2, Fairly concerned = 3, Very concerned = 4; Lowest score = 16, Highest score = 64, lower scores indicated less FOF (better), higher scores indicated more FOF (worse), total score divided by 64.

Surveys will be conducted at the initial visit, week 2, 5, 8, and 12.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月31日

初级完成 (估计的)

2027年4月27日

研究完成 (估计的)

2027年4月27日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月9日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Shepherd Center will publish findings as appropriate and will maintain confidential records as necessary.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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