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临床试验/NCT01936922
NCT01936922已完成1 期

Testing Whether Brief Use of a Wearable Virtual Reality Device Improves Gait, Balance, and Confidence After Falls

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Step length

研究概览

简要总结

A virtual reality device has already been successfully used for improving gait in adults who have neurological conditions. We will evaluate if it is feasible to study the brief use of this device in older adults who have had falls.

详细描述

Older adults are at risk for recurrent falls.

This study will involve a single study session (lasting two hours) in the controlled setting of a research laboratory. This study will evaluate whether older adults who have had unintentional falls are willing to enroll in this kind of study, use the device briefly, and undergo research assessments. The study will also test whether using the virtual reality device leads to detectable changes in gait, balance, and mobility confidence. This study will lay the groundwork for more comprehensive studies in the future that will assess the clinical impact of using the device.

Twenty-four subjects will be recruited. They will include equal numbers of older adults who: (1) have fallen without a significant injury (e.g. only minor contusion, lacerations) or (2) have fallen with a significant injury (e.g. dislocation, strain/sprain, or fracture) which has healed prior to enrollment.

Each subject will complete baseline measures of gait, balance, and confidence. Then she or he will be introduced to the virtual reality device and will use it for a brief period. Gait and balance will be tested again, first with the virtual reality device and then, finally, without the virtual reality device.

The device (GaitAid®), developed by co-investigator Yoram Baram, Ph.D., has already been used for the rehabilitation of neurological patients (e.g. Parkinson's Disease). The device is a training tool and NOT a continuous walking aid.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • English-speaking.
  • One or more unintentional falls in past year.
  • Able to ambulate for at least 10 minutes without continuous assistance, i.e., without human physical assistance and without an assistive device such as a walker, or a cane.
  • A moderate or high level of concern about falling (determined by phone screening by PI).
  • Community dwelling.

排除标准

  • Diagnosed with any neurological disease, i.e., sensory ataxia, cerebellar ataxia, or spasticity of the lower limbs.
  • Diagnosed with Parkinson's Disease.
  • Diagnosed with Multiple Sclerosis.
  • Diagnosed with Cerebral Palsy.
  • Marked cognitive impairment.
  • Uses large eyeglasses to walk.
  • Vision conditions that reduce ability to use the device.
  • Severe hearing loss.
  • Unstable medical condition or terminal illness.
  • Inability to otherwise comply with the study procedures (determined by PI/study clinician).

结局指标

主要结局

Step length

时间窗: Two hours

Step length will be measured by GaitMat II® at three time points within the single study session: before using the virtual reality device, while using the virtual reality device, and after using the virtual reality device.

次要结局

  • Walking velocity(Two hours)
  • Postural Sway(Two hours)
  • Fear of Falling(Two hours)
  • Single support time(Two hours)

研究者

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

Nimali Jayasinghe

Assistant Professor of Psychology

Weill Medical College of Cornell University

研究点 (1)

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