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临床试验/NCT07633093
NCT07633093已完成不适用

Acute Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Community-Dwelling Older Adults: A Randomized Crossover Trial

Hunan Normal University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2

研究概览

简要总结

The goal of this clinical trial is to learn whether a powered wearable lower-limb exoskeleton can improve walking performance in independently ambulatory older adults aged 65 to 75 years.

The main questions it aims to answer are:

  • Does use of a powered lower-limb exoskeleton increase comfortable walking speed over 10 meters?
  • Does use of a powered lower-limb exoskeleton increase average walking speed during a 400-meter walk?

Researchers will compare walking performance in older adults during walking with the powered exoskeleton and walking without the device to determine whether the exoskeleton improves mobility. Young-adult reference participants will also complete walking assessments to provide reference values for walking performance.

Participants will:

  • Attend a screening and familiarization visit.
  • Complete walking assessments with and without the powered exoskeleton in randomized order (older adults only).
  • Perform a 10-meter walk test, a 400-meter walk test, and other physical performance assessments.
  • Complete questionnaires about balance confidence, fear of falling, and device usability.
  • Be monitored for safety events during testing.

详细描述

Age-related decline in mobility is associated with reduced independence, lower quality of life, and increased risk of disability and adverse health outcomes. Walking performance is a clinically meaningful indicator of functional status in older adults, and preservation of mobility is a major goal of healthy aging. Although exercise and rehabilitation interventions can improve mobility, their benefits typically require repeated training and sustained adherence. Technologies that provide immediate assistance during walking may offer a complementary approach to supporting mobility in older adults.

Powered wearable lower-limb exoskeletons are designed to provide external mechanical assistance during locomotion. Previous studies have shown that lower-limb exoskeletons can reduce the metabolic cost of walking and improve walking performance under laboratory conditions. However, less is known about the acute effects of commercially available exoskeleton systems on clinically relevant walking outcomes in independently ambulatory older adults.

This study will evaluate the acute effects of a commercially available powered lower-limb exoskeleton on walking performance in community-dwelling older adults. The primary outcomes are comfortable gait speed during a 10-meter walk test and average walking speed during a 400-meter walk test. Secondary outcomes include lower-extremity physical performance, physiological responses during walking, perceived exertion, balance confidence, fear of falling, device usability, participant satisfaction, and safety outcomes.

The study uses a randomized crossover design. Older adult participants will complete two experimental conditions in randomized order: walking without the exoskeleton and walking with the powered exoskeleton. Participants will attend a screening and familiarization visit followed by two trial visits separated by at least 48 hours. During the familiarization visit, participants will receive device fitting and supervised practice with the exoskeleton. At each trial visit, participants will complete standardized walking and physical performance assessments under the assigned condition.

A young-adult reference group will complete no-device walking assessments to provide reference values for walking performance. Exploratory analyses will examine whether exoskeleton-assisted walking reduces the performance gap between older adults and young adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

盲法说明

Due to the visible nature of the powered lower-limb exoskeleton intervention, neither participants nor study personnel could be blinded to condition assignment. All assessments were therefore conducted under open-label conditions.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older adults aged 65 to 75 years who are community-dwelling, independently ambulatory, able to walk independently on level ground, able to maintain standing balance without personal assistance, and able to understand study instructions.
  • Young-adult reference participants aged 18 to 22 years who are healthy university students without known conditions affecting walking or balance.

排除标准

  • Self-reported neurological disease affecting gait or balance.
  • Major musculoskeletal injury or surgery affecting walking within the previous 6 months.
  • Uncontrolled cardiopulmonary disease.
  • Severe visual or vestibular impairment affecting safe walking.
  • Current lower-limb pain that limits walking.
  • Cognitive impairment that prevents informed consent or protocol adherence.
  • Any condition judged by the study team to make participation unsafe.

研究组 & 干预措施

Older Adults

Experimental

Community-dwelling older adults aged 65-75 years who complete walking assessments under both no-device and powered-exoskeleton conditions in randomized order using a crossover design. Participants attend a screening and familiarization visit followed by two trial visits.

干预措施: Powered Lower-Limb Exoskeleton (Device)

Young Adult Reference Participants

No Intervention

Healthy young adults aged 18-22 years who complete no-device walking assessments to provide reference values for walking performance. Participants are not randomized and do not receive the powered exoskeleton intervention.

结局指标

主要结局

未指定

次要结局

  • Borg Rating of Perceived Exertion(Immediately after the 400-meter walk test during each trial visit, up to 5 days.)
  • Fear of Falling 10-Rating Scale Score(After physical performance testing during each trial visit, up to 5 days.)
  • Activities-specific Balance Confidence Scale Score(After physical performance testing during each trial visit, up to 5 days.)
  • System Usability Scale Score(After completion of the powered-device trial visit, up to 5 days.)
  • Quebec User Evaluation of Satisfaction With Assistive Technology 2.0 Device Subscale Score(After completion of the powered-device trial visit, up to 5 days.)

研究者

发起方
Hunan Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Zhang

Independent Scientific Advisor

Hunan Normal University

研究点 (2)

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