Clinical trial NCT06041100: What Are the Effects of a Bilateral Hip Exoskeleton During Daily Use by 65+ Adults?
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-frail Senior Adults
Keywords: exoskeleton
aging
walking
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Imasen Electrical Industrial Co., Ltd.
name: Aalborg Municipality
First posted: 2023-09-18
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will complete three test sessions:

1. An initial assessment (baseline)
2. A 4-week assessment and
3. A 12-week assessment.
4. Around 8-10 participants will be invited for a follow-up assessment 6-weeks post after the trial has ended.

All participants will be instructed to wear the device 30 minutes daily during moderate to intensive physical activities. They will be required to provide a weekly overview of their usage and experience with the device.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Walking speed
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Step length
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Double support time
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Cadence
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Secondary outcomes:
measure: Heart rate
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Perceived effort
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Physical activity levels
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Self-reporting of exoskeleton-use during the 12-weeks intervention
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Wearability
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Qualitative data
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial.]
measure: Acceptability
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Life quality
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Age
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: BMI
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
measure: Frailty
timeFrame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Other outcomes:
Locations:
city: Gistrup
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Cristina-Ioana Pirscoveanu
role: PRINCIPAL_INVESTIGATOR
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