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临床试验/NCT05205980
NCT05205980招募中不适用

Motor Learning of Fall Resistant Skills From Laboratory-induced Falling Among People With Mild Alzheimer's Disease

Georgia State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年4月28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
30
试验地点
1
主要终点
Lab-induced faller rate

研究概览

简要总结

This study will examine the overall capacity of people with Alzheimer's disease learning fall-resistant skills from perturbation training.

详细描述

Falls can cause injury and death in older adults. Those with Alzheimer's disease are at an even higher fall risk. Our goal is to test if people with mild Alzheimer's disease can learn fall prevention skills from the exposure to large-scale perturbations on a treadmill. Two groups with mild Alzheimer's disease will be enrolled. One group will attend a perturbation training session while the other group receives no training. Groups will then be exposed to perturbations on the ground immediately and three or six months after the training. Over six months after the training, daily-living falls will be tracked for both groups. The falls following the perturbations in the lab and daily-living all-cause falls will be compared between groups to test our specific aims: 1) to test if people with Alzheimer's disease can adapt to large-scale external perturbations and learn fall resistant motor skills; 2) to inspect whether people with Alzheimer's disease can retain motor skills learned in Aim 1; and 3) to determine if people with Alzheimer's disease can generalize fall resistant skills to different contexts (treadmill to overground, inside the lab to outside the lab).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The assessor will be blinded to the group assignment of each participant.

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

  • Participants must be at least 65 years old;
  • Participants have a clinical diagnosis of probable AD;
  • Participants can read and understand English;
  • Participants must be able to walk independently at least 25 feet;
  • Participants must be able to stand independently for at least 30 seconds;
  • Participants must have a Montreal Cognitive Assessment score of 11-21 or Mini Mental Status Examination score between 18 and 23.

排除标准

  • Individuals have ever experienced perturbation training;
  • Individuals have hypotension or uncontrolled hypertension;
  • Individuals exhibit osteoporosis;
  • Participants suffer from coexisting psychiatric disorders, or other neurological conditions, or injuries, etc.

研究组 & 干预措施

Training group

Experimental

This arm will receive a single-session perturbation training treatment on a treadmill under the protection of a safety harness.

干预措施: Perturbation training (Behavioral)

Control group

Sham Comparator

This arm will not receive perturbation training but will go through harnessed walking on the same treadmill for the same time as the other group.

干预措施: Perturbation training (Behavioral)

结局指标

主要结局

Lab-induced faller rate

时间窗: 6 months

The outcome of each perturbation trial will be determined as a fall if the peak load cell force exceeds 30% of the body weight. The load cell records the force applied to the human body by the safety harness system after a perturbation. The lab-induced faller rate will be calculated as the ratio of the number of fallers to the number of participants within each group.

次要结局

  • Number of prospective fall incident(6 months)
  • Dynamic stability(6 months)

研究者

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

Feng Yang, PhD

Associate Professor

Georgia State University

研究点 (1)

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