Completed

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

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What is being tested

Exoskeleton

Device
Who is being recruted

From 65 to 85 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2023
See protocol details

Summary

Principal SponsorAalborg University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 6, 2023

Actual date on which the first participant was enrolled.

This study focuses on exploring how wearing a lower-limb exoskeleton over an extended period affects physical activity levels and quality of life in older adults who are considered pre-frail. Pre-frail individuals may exhibit signs of frailty such as weight loss, slower mobility, or reduced physical activity, making it challenging to maintain a healthy lifestyle. The study acknowledges that as people age, they may experience walking difficulties that impact their daily activities and overall well-being. Exoskeletons, which are wearable devices that assist with walking, have shown promise in improving walking speed, reducing energy expenditure, and preventing falls. This research is important as it seeks to determine if the benefits of using these devices are sustainable over time, which could significantly enhance the independence and quality of life for older adults. In this interventional study, participants will wear a non-invasive passive hip exoskeleton consistently for 12 weeks. The study aims to evaluate changes in their walking patterns and overall mobility by analyzing specific characteristics of their gait. Additionally, the research will assess whether the improvements in physical activity and quality of life persist for six weeks after they stop using the exoskeleton. This will involve tracking how the participants move and their ability to engage in daily activities. By understanding the long-term effects of exoskeleton use, the study hopes to provide insights into new ways to support older adults in maintaining active and independent lifestyles.

Official TitleAssessing the Long-term Effects of Wearing a Lower-limb Exoskeleton on Physical Activity and Quality of Life in Pre-frail Adults - a Feasibility Study
NCT06041100
Principal SponsorAalborg University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 65 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
score of ≤ 5 on the Tilburg Frailty index

able to walk independently without walking aids.

4 exclusion criteria prevent from participating
score of >6 on the Tilburg Frailty index

uncorrected visual or hearing impairments

Vestibular dysfunctions

current use of walking aids.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
30 minutes of daily wearing an exoskeleton for 12-weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Aalborg University

Gistrup, DenmarkOpen Aalborg University in Google Maps
CompletedOne Study Center