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临床试验/NCT05140044
NCT05140044已完成不适用

Longitudinal Home-based Evaluation of Balance and Exercise in Older Adults With and Without a History of Falls

Binghamton University2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Dual Task Gait Velocity

研究概览

简要总结

Approximately one-third of older adults report one or more falls each year, with devastating physical, psychological, social, and financial consequences. Conventional gait analysis performed in a controlled laboratory environment can identify balance deficits, but unfortunately, such tools are bulky, time-consuming, and dependent on qualified technicians to properly collect and evaluate the data. Furthermore, these one-time gait and balance assessments cannot monitor changes in ambulatory strategies longitudinally and do not reflect performance in real-life environments, where falls commonly occur. While recent developments in smartphone-based evaluations have demonstrated great utility and accuracy in assessing gait performance, it is vital to evaluate participant compliance, ease-of-use, and feasibility of this technology using a smartphone in the home environment.

It is also paramount that interventions which improve balance be accessible to older adults. While four-week balance training routines have been shown to improve balance performance among older adults, it is unknown whether such interventions can be conducted remotely in a safe and compliant manner. Furthermore, the retention of balance function following intervention is unclear. Subsequently, the goals of this study are to evaluate technology that can both remotely monitor balance and prescribe intervention to older adults. With the current burdens on the health care system and the burgeoning population of older adults, it is essential that tools be provided to older adults that are easy to follow, attractive, and improve balance performance.

Therefore, the objective of this project is to investigate the utility of a valid, easily accessible, smartphone application to assess balance and provide personalized exercise for older adults as a stand-alone, field-based medical device. The aims of this proposal are to (1) utilize a smartphone application to longitudinally evaluate gait and standing balance over an 8-week period in the home environment among 30; and (2) determine the feasibility and efficacy of a smartphone application to promote exercise and evaluate gait changes for up to 2 months in this older adult population following a 4-week balance intervention. The long-term goal of this project is to provide a holistic home-based gait monitoring and intervention tool for integration in routine clinical care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to ambulate at least 10 meters without an assistive device.
  • Cognitively intact based on scoring 18/22 or greater on the Montreal Cognitive Assessment (MOCA) - Blind.

排除标准

  • Lower limb amputation
  • Lower limb arthroplasty
  • Visual impairment uncorrectable with lenses
  • Uncontrolled hypertension or diabetes
  • Neurological or musculoskeletal impairment
  • Persistent symptoms of dizziness or lightheadedness

结局指标

主要结局

Dual Task Gait Velocity

时间窗: Two-months following baseline

self-selected walking speed under dual task gait/cognitive conditions

次要结局

  • Dual Task Standing Balance(Two-months following baseline)
  • Dual Task Verbal Reaction Time(Two-months following baseline)

研究者

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

Vipul Lugade

Associate Professor and Director of Motion Analysis Research Laboratory

Binghamton University

研究点 (2)

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