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临床试验/NCT06041100
NCT06041100已完成不适用

Assessing the Long-term Effects of Wearing a Lower-limb Exoskeleton on Physical Activity and Quality of Life in Pre-frail Adults - a Feasibility Study

Aalborg University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Step length

研究概览

简要总结

Despite the huge popularity exoskeletons have gained in the past years and the benefits that they have shown to provide to users, there are still many aspects of wearing an exoskeleton that have yet to be determined. Therefore, the main objective of this study is to evaluate the feasibility using the acceptability of incorporating a passive assistive bilateral exoskeleton into the daily routine of pre-frail adults for a duration of 12-weeks. The second aim of the study is to determine whether this effect can be sustained even after a period of 6-weeks following the cessation of usage.

详细描述

Despite the high benefits of performing physical activity in terms of physical and cognitive function, between 27-38% of Danish older adults do not meet the required physical activity recommendations. Due to the longer life expectancy, the increasingly older population will face gait disorders. These gait disorders will affect their motor and cognitive functions, and impair the performance of daily physical activity and overall quality of life. Frailty is one of the most frequent aging-related deficits observed in older adults, often characterized by three of the following criteria: unintentional weight loss >4.5 kg within the last year, exhaustion, loss or slower mobility, loss of grip strength, and low physical activity. However, pre-frail adults may present some of the aforementioned criteria and a score of ≤5 on the Tilburg Frailty Indicator. Therefore, there is an increasing need to provide the aging population with devices capable of promoting physical activity and independent living. Exoskeletons have been shown to facilitate physical activity in the older adult population by improving metabolic costs, increasing walking speed, and preventing falls. However, whether these benefits are only temporary, or can be maintained over a longer period, remains to be determined. Therefore, it is of pivotal importance to assess the long-term effects of exoskeletons, in terms of mobility, within the older adult population.

The use of external mechanical walking devices started in the late 1890s. However, only in the past two decades have gait-assisting exoskeletons, with increased human performance capability, gained popularity. Exoskeletons have been shown to reduce metabolic cost, and fatigue onset and increase walking velocity. Currently on the market, there are several lower-limb exoskeletons that target older populations and people with gait and neurological disabilities which are designed to enhance walking performance and reduce the muscle activation required during walking activities. Wearing gait-assisting exoskeletons can provide instant ease, delay fatigue onset, increase social engagement, and support rehabilitation to recover normal walking capabilities. The effects of hip exoskeletons have been previously investigated in terms of quality of life and improvement of gait performance. However, the effect of long-term use has yet to be assessed. Hence, this study aims to evaluate the impact of extended usage of a non-invasive passive hip exoskeleton on the quality of life of older adults. This will be achieved by analyzing the spatiotemporal gait characteristics in a feasibility study conducted over a 12-week period of consistent device usage. Additionally, the study aims to ascertain the persistence of these effects for a duration of 6 weeks post-usage.

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

入选标准

  • score of ≤ 5 on the Tilburg Frailty index
  • able to walk independently without walking aids.

排除标准

  • score of >6 on the Tilburg Frailty index
  • uncorrected visual or hearing impairments
  • Vestibular dysfunctions
  • current use of walking aids.

结局指标

主要结局

Step length

时间窗: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial

Changes in step length (cm) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).

Walking speed

时间窗: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial

Changes in speed (m/s) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).

Double support time

时间窗: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial

Changes in double support time (s) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).

Cadence

时间窗: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial

Changes in cadence (steps/minute) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).

次要结局

  • Heart rate(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)
  • Perceived effort(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)
  • Physical activity levels(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)
  • Self-reporting of exoskeleton-use during the 12-weeks intervention(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)
  • Life quality(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)
  • Age(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)
  • Acceptability(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)
  • BMI(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)
  • Wearability(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)
  • Qualitative data(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial.])
  • Frailty(Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial)

研究者

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

Cristina-Ioana Pirscoveanu

Principal Investigator

Aalborg University

研究点 (2)

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