Pre-frail Senior AdultsNCT06041100
What Are the Effects of a Bilateral Hip Exoskeleton During Daily Use by 65+ Adults?
A study testing Exoskeleton in people with Pre-frail Senior Adults, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-frail Senior Adults
- What is being tested?
- Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Sep 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- score of ≤ 5 on the Tilburg Frailty index
- able to walk independently without walking aids.
Who cannot join
- score of >6 on the Tilburg Frailty index
- uncorrected visual or hearing impairments
- Vestibular dysfunctions
- current use of walking aids.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pre-frail Senior Adults
- Being tested
- Exoskeleton
- Keywords
- exoskeleton, aging, walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoskeletonDevice
Use a passive assistive hip exoskeleton (alQ, Imasen Electrical Industrial Co., Ltd.) for 30 minutes daily during moderate to intensive activities over a period of 12-weeks. The exoskeleton is designed to aid hip flexion and as such its primary role is to improve gait by increasing step length and improving speed. The amount of time the exoskeleton has been used will be weekly monitored through phone calls and two gait sessions will be conducted to measure the development.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 30 minutes of daily wearing an exoskeleton for 12-weeks Receives: Device: Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
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).
Measured: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Step length
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).
Measured: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Double support time
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).
Measured: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Cadence
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).
Measured: 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 (11)
Heart rate
using a chest strap device which will be monitored during the gait measurement
Measured: 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
assessed using Borg Category-Ratio (CR) scale (0 = No effort, 10 = Maximal effort) to evaluate the work tasks conducted during the pre- and post-tests.
Measured: 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
assessed using a questionnaire (The International Physical Activity Questionnaire) to determine the kind and level of the physical activity performed within the past 7 days. The questionnaire will be applied at baseline and every week for the entire duration of the intervention.
Measured: 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
assessed using yes/ no, metric and open-ended questions on usage: Q1: "Did you wear the device this week?", Q2: "How much did you wear the device every day? " Q3: "What activities did you predominately performed with the device?". The questionnaire will be applied at baseline and every week for the entire duration of the intervention.
Measured: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Wearability
assessed using yes/ no and open-ended questions on ease/discomfort of wearing the device: Q1: "Did you have any technical problems with the device broken/stuck?" Q2: "Did you have any physical problems with the device pain/discomfort?" Q3: "Did see or feel any improvements in your ability to walk?" 4. "How would you describe your experience so far in few words? ". The questionnaire will be applied at baseline and every week for the entire duration of the intervention.
Measured: 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
Assessed using a semi-constructed interview with yes/ no and open-ended questions on the overall experience of using the device.
Measured: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial.]
Acceptability
of incorporating a passive assistive bilateral exoskeleton into the daily routine of pre-frail adults for a duration of 12-weeks using the acceptability questionnaire that has a 7-point Liker scale ranging from "very unacceptable" to "very acceptable".
Measured: 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
assessed using a questionnaire the EQ-5D-5L which evaluates five dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety, and discomfort) at five severity levels ranging from no effect/symptom to slightly, moderate, severe, and extreme.
Measured: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Age
will be collected as descriptive statistics and for the inclusion criteria.
Measured: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
BMI
will be assessed by collecting weigth and height.
Measured: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Frailty
assessed using a questionnaire the Tilburg Frailty Index which evaluates frailty levels for the inclusion criteria.
Measured: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start6 Sep 2023
- Primary completion30 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Pre-frail Senior AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Imasen Electrical Industrial Co., Ltd., Aalborg Municipality
- Responsible party
- Principal investigator, Cristina-Ioana Pirscoveanu, Aalborg University
- Investigators
- Cristina-Ioana Pirscoveanu, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041100
- Sponsor's protocol ID
- AAU2-LBK1083
- Status last verified
- Jan 2024
- First submitted
- 1 Sep 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andreasen J, Lund H, Aadahl M, Gobbens RJ, Sorensen EE. Content validation of the Tilburg Frailty Indicator from the perspective of frail elderly. A qualitative explorative study. Arch Gerontol Geriatr. 2015 Nov-Dec;61(3):392-9. doi: 10.1016/j.archger.2015.08.017. Epub 2015 Aug 24.
PubMed 26323651Asselin P, Knezevic S, Kornfeld S, Cirnigliaro C, Agranova-Breyter I, Bauman WA, Spungen AM. Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. J Rehabil Res Dev. 2015;52(2):147-58. doi: 10.1682/JRRD.2014.02.0060.
PubMed 26230182Bangsbo J, Blackwell J, Boraxbekk CJ, Caserotti P, Dela F, Evans AB, Jespersen AP, Gliemann L, Kramer AF, Lundbye-Jensen J, Mortensen EL, Lassen AJ, Gow AJ, Harridge SDR, Hellsten Y, Kjaer M, Kujala UM, Rhodes RE, Pike ECJ, Skinner T, Skovgaard T, Troelsen J, Tulle E, Tully MA, van Uffelen JGZ, Vina J. Copenhagen Consensus statement 2019: physical activity and ageing. Br J Sports Med. 2019 Jul;53(14):856-858. doi: 10.1136/bjsports-2018-100451. Epub 2019 Feb 21.
PubMed 30792257Brustio PR, Magistro D, Zecca M, Rabaglietti E, Liubicich ME. Age-related decrements in dual-task performance: Comparison of different mobility and cognitive tasks. A cross sectional study. PLoS One. 2017 Jul 21;12(7):e0181698. doi: 10.1371/journal.pone.0181698. eCollection 2017.
PubMed 28732080Chen B, Zi B, Qin L, Pan Q. State-of-the-art research in robotic hip exoskeletons: A general review. J Orthop Translat. 2019 Oct 14;20:4-13. doi: 10.1016/j.jot.2019.09.006. eCollection 2020 Jan.
PubMed 31908928Collins SH, Wiggin MB, Sawicki GS. Reducing the energy cost of human walking using an unpowered exoskeleton. Nature. 2015 Jun 11;522(7555):212-5. doi: 10.1038/nature14288. Epub 2015 Apr 1.
PubMed 25830889Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Khosravi P, Ghapanchi AH. Investigating the effectiveness of technologies applied to assist seniors: A systematic literature review. Int J Med Inform. 2016 Jan;85(1):17-26. doi: 10.1016/j.ijmedinf.2015.05.014. Epub 2015 Jun 11.
PubMed 26216463Lange-Maia BS, Newman AB, Strotmeyer ES, Harris TB, Caserotti P, Glynn NW. Performance on fast- and usual-paced 400-m walk tests in older adults: are they comparable? Aging Clin Exp Res. 2015 Jun;27(3):309-14. doi: 10.1007/s40520-014-0287-y. Epub 2014 Nov 6.
PubMed 25373610Lee SH, Lee HJ, Chang WH, Choi BO, Lee J, Kim J, Ryu GH, Kim YH. Gait performance and foot pressure distribution during wearable robot-assisted gait in elderly adults. J Neuroeng Rehabil. 2017 Nov 28;14(1):123. doi: 10.1186/s12984-017-0333-z.
PubMed 29183379McPhee JS, French DP, Jackson D, Nazroo J, Pendleton N, Degens H. Physical activity in older age: perspectives for healthy ageing and frailty. Biogerontology. 2016 Jun;17(3):567-80. doi: 10.1007/s10522-016-9641-0. Epub 2016 Mar 2.
PubMed 26936444Mundt M, Batista JP, Markert B, Bollheimer C, Laurentius T. Walking with rollator: a systematic review of gait parameters in older persons. Eur Rev Aging Phys Act. 2019 Sep 10;16:15. doi: 10.1186/s11556-019-0222-5. eCollection 2019.
PubMed 31528238Panizzolo FA, Bolgiani C, Di Liddo L, Annese E, Marcolin G. Reducing the energy cost of walking in older adults using a passive hip flexion device. J Neuroeng Rehabil. 2019 Oct 15;16(1):117. doi: 10.1186/s12984-019-0599-4.
PubMed 31615535Sawicki GS, Beck ON, Kang I, Young AJ. The exoskeleton expansion: improving walking and running economy. J Neuroeng Rehabil. 2020 Feb 19;17(1):25. doi: 10.1186/s12984-020-00663-9.
PubMed 32075669Shin CN, Lee YS, Belyea M. Physical activity, benefits, and barriers across the aging continuum. Appl Nurs Res. 2018 Dec;44:107-112. doi: 10.1016/j.apnr.2018.10.003. Epub 2018 Oct 17.
PubMed 30389054
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06041100
- Acronym / sponsor ID
- AAU2-LBK1083
- Conditions
- Pre-frail Senior Adults
- Keywords
- exoskeleton, aging, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Imasen Electrical Industrial Co., Ltd., Aalborg Municipality
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Exoskeleton30 minutes of daily wearing an exoskeleton for 12-weeks |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- score of ≤ 5 on the Tilburg Frailty index
- able to walk independently without walking aids.
Key exclusion criteria (4 listed)
- score of >6 on the Tilburg Frailty index
- uncorrected visual or hearing impairments
- Vestibular dysfunctions
- current use of walking aids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExoskeletonUse a passive assistive hip exoskeleton (alQ, Imasen Electrical Industrial Co., Ltd.) for 30 minutes daily during moderate to intensive activities over a period of 12-weeks. The exoskeleton is designed to aid hip flexion and as such its primary role is to improve gait by increasing step length and improving speed. The amount of time the exoskeleton has been used will be weekly monitored through phone calls and two gait sessions will be conducted to measure the development. | Device | Intervention |
Primary outcome
Walking speed
Time frame: 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).
Step length
Time frame: 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).
Double support time
Time frame: 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
Time frame: 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).
11 secondary outcomes
Heart rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Wearability
Time frame: 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
Time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial.]
Acceptability
Time frame: 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
Time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Age
Time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
BMI
Time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Frailty
Time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 26323651Andreasen J, Lund H, Aadahl M, Gobbens RJ, Sorensen EE. Content validation of the Tilburg Frailty Indicator from the perspective of frail elderly. A qualitative explorative study. Arch Gerontol Geriatr. 2015 Nov-Dec;61(3):392-9. doi: 10.1016/j.archger.2015.08.017. Epub 2015 Aug 24.
- Background: PubMed 26230182Asselin P, Knezevic S, Kornfeld S, Cirnigliaro C, Agranova-Breyter I, Bauman WA, Spungen AM. Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. J Rehabil Res Dev. 2015;52(2):147-58. doi: 10.1682/JRRD.2014.02.0060.
- Background: PubMed 30792257Bangsbo J, Blackwell J, Boraxbekk CJ, Caserotti P, Dela F, Evans AB, Jespersen AP, Gliemann L, Kramer AF, Lundbye-Jensen J, Mortensen EL, Lassen AJ, Gow AJ, Harridge SDR, Hellsten Y, Kjaer M, Kujala UM, Rhodes RE, Pike ECJ, Skinner T, Skovgaard T, Troelsen J, Tulle E, Tully MA, van Uffelen JGZ, Vina J. Copenhagen Consensus statement 2019: physical activity and ageing. Br J Sports Med. 2019 Jul;53(14):856-858. doi: 10.1136/bjsports-2018-100451. Epub 2019 Feb 21.
- Background: PubMed 28732080Brustio PR, Magistro D, Zecca M, Rabaglietti E, Liubicich ME. Age-related decrements in dual-task performance: Comparison of different mobility and cognitive tasks. A cross sectional study. PLoS One. 2017 Jul 21;12(7):e0181698. doi: 10.1371/journal.pone.0181698. eCollection 2017.
- Background: PubMed 31908928Chen B, Zi B, Qin L, Pan Q. State-of-the-art research in robotic hip exoskeletons: A general review. J Orthop Translat. 2019 Oct 14;20:4-13. doi: 10.1016/j.jot.2019.09.006. eCollection 2020 Jan.
- Background: PubMed 25830889Collins SH, Wiggin MB, Sawicki GS. Reducing the energy cost of human walking using an unpowered exoskeleton. Nature. 2015 Jun 11;522(7555):212-5. doi: 10.1038/nature14288. Epub 2015 Apr 1.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 26216463Khosravi P, Ghapanchi AH. Investigating the effectiveness of technologies applied to assist seniors: A systematic literature review. Int J Med Inform. 2016 Jan;85(1):17-26. doi: 10.1016/j.ijmedinf.2015.05.014. Epub 2015 Jun 11.
- Background: PubMed 25373610Lange-Maia BS, Newman AB, Strotmeyer ES, Harris TB, Caserotti P, Glynn NW. Performance on fast- and usual-paced 400-m walk tests in older adults: are they comparable? Aging Clin Exp Res. 2015 Jun;27(3):309-14. doi: 10.1007/s40520-014-0287-y. Epub 2014 Nov 6.
- Background: PubMed 29183379Lee SH, Lee HJ, Chang WH, Choi BO, Lee J, Kim J, Ryu GH, Kim YH. Gait performance and foot pressure distribution during wearable robot-assisted gait in elderly adults. J Neuroeng Rehabil. 2017 Nov 28;14(1):123. doi: 10.1186/s12984-017-0333-z.
- Background: PubMed 26936444McPhee JS, French DP, Jackson D, Nazroo J, Pendleton N, Degens H. Physical activity in older age: perspectives for healthy ageing and frailty. Biogerontology. 2016 Jun;17(3):567-80. doi: 10.1007/s10522-016-9641-0. Epub 2016 Mar 2.
- Background: PubMed 31528238Mundt M, Batista JP, Markert B, Bollheimer C, Laurentius T. Walking with rollator: a systematic review of gait parameters in older persons. Eur Rev Aging Phys Act. 2019 Sep 10;16:15. doi: 10.1186/s11556-019-0222-5. eCollection 2019.
- Sundhedsstyrelsen. Danskernes Sundhed - Tal fra Den Nationale SundhedsprofilLink provided by the sponsor.
- World Health Organization. Denmark Physical activity factsheet 2018Link provided by the sponsor.
- Zhang et al., 2019 - Design and Control of a Series Elastic Actuator With Clutch for Hip Exoskeleton for Precise Assistive Magnitude and Timing Control and Improved Mechanical SafetyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina-Ioana Pirscoveanu principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton in people with Pre-frail Senior Adults, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06041100, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.