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临床试验/NCT06396650
NCT06396650招募中不适用

Assessment of Fall Risks and Subject-specific Training for Fall Reduction

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Fall risks

研究概览

简要总结

The target population of this project is older people with high risks of falls. About 30% community-dwelling individuals over 65 years of age fall each year and the rate of fall related injuries leading to loss of function and independence increases with age. Falls are the leading cause of fatal and non-fatal injuries and the leading cause traumatic brain injury in older adults. Slip-related falls in older adults comprise 40% of outdoor falls and are the leading cause of hip fracture or traumatic head injury. In 2012, 2.4 million non-fatal falls were treated in emergency room visits with $30 billion dollars spent on direct medical costs. In addition to fractures and traumatic brain injury, nonfatal falls frequently lead to reduced levels of activity, fear of falling, and reduced quality of life. Clearly, advancing the predictive, preventative, and rehabilitative methods aimed at reducing the risk of injurious falls in this population is imperative. Although falls are multi-factorial in nature, there has been few individualized assessment of the biomechanical causes of falls.

The purpose of this study is to conduct subject-specific training on older adults with fall risks with combined home-hospital rehabilitation. This project will involve rehabilitation interventions based on the characteristics of falling patterns and older adults with reduced capability controlling the balance. To conduct subject-specific fall prevention training. based on identified individual fall mechanisms.

详细描述

Forty older adults (study group) with high risk of fall (i.e. with one or more fall in the past 12 months) will be recruited. The fall mechanisms will be examined in previous Aims 1 and 2 part of this study.

Assessments will be conducted to identify the fall risks and falling mechanisms by measuring subjects' responses to the movements of the footplates the subject stands on. Training procedures will then be designed for each subject, including training both in the research lab (once per week) and at home (three times per week) for six weeks. The subject will also revisit the lab for a follow-up assessment two months after the 6-week training.

Based on the identified falling mechanisms, a specific training for each subject will be set up using the sliding stepping fall rehabilitation system for one session per week over six weeks in the lab. The participants will also do home training exercises 3 times per week after initial in-lab instructed training. Participants will come to the lab and have biomechanical and clinical evaluations before and after the 6-week training (called Pre & Post), and then at a two-month follow-up as the final evaluation for total three times of evaluations.

All the subjects will be informed about the experimental procedures, and sign an IRB approved consent form prior to study participation and experimental tests.

All participants will be protected from the risk of falling with a harness system. The harness is mounted in mobile cart. A researcher will push the mobile cart following the participant's walking while walking on the ground.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 to 85 years old
  • Have a family member at home for safety.
  • There is no severe injury or pain at the lower extremities.
  • With one or more falls in the past 12 months or walk with instability
  • Individuals who are taking medication, there should be no planned medication changes for the study duration of 3.5 months.
  • All the participants should be capable of independent walking.

排除标准

  • Enrollment in another lower limb rehabilitation program;
  • severe pain in the lower limbs;
  • previous myocardial infarction
  • Body weight over 280 lbs
  • Cognitive impairment (Mini-Mental Status Examination (MMSE) score less than 25)

研究组 & 干预措施

Lab and home-based training

Experimental

Conduct balance training and/or lower-limb muscle strengthening in lab and at home

干预措施: Home-based training (Device)

Lab and home-based training

Experimental

Conduct balance training and/or lower-limb muscle strengthening in lab and at home

干预措施: Lab-based training (Device)

结局指标

主要结局

Fall risks

时间窗: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training

Berg Balance Scale (BBS) evaluation will be used which provides a value for fall risks assessment.

次要结局

  • Lower limb muscle strength(The first visit, immediately after the training, and a follow-up evaluation session two-month after the training)
  • Body kinematcis during walking(The first visit, immediately after the training, and a follow-up evaluation session two-month after the training)
  • Body reactions against perturbations(The first visit, immediately after the training, and a follow-up evaluation session two-month after the training)
  • Ground impact forces captured by forces plates during walking(The first visit, immediately after the training, and a follow-up evaluation session two-month after the training)

研究者

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

Li-Qun Zhang

Professor

University of Maryland, Baltimore

研究点 (1)

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