What Are the Effects of a Bilateral Hip Exoskeleton During Daily Use by 65+ Adults?

NCT06041100 | Completed DMC

• 1 other identifier: AAU2-LBK1083
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-frail Senior Adults

Keywords

exoskeleton; aging; walking

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  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

  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

• Wearability

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

Study Arms (1)

Intervention

EXPERIMENTAL

30 minutes of daily wearing an exoskeleton for 12-weeks

Device: Exoskeleton

Interventions

Exoskeleton DEVICE

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.

Intervention

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University: lead
• Imasen Electrical Industrial Co., Ltd.: collaborator
• Aalborg Municipality: collaborator

Study Sites (1)

Aalborg University

Gistrup, North Denmark, 9210, Denmark

Location

Related Publications (19)

• 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.

  PMID: 26323651 BACKGROUND

• Asselin 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.

  PMID: 26230182 BACKGROUND

• Bangsbo 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.

  PMID: 30792257 BACKGROUND

• Brustio 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.

  PMID: 28732080 BACKGROUND

• Chen 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.

  PMID: 31908928 BACKGROUND

• Collins 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.

  PMID: 25830889 BACKGROUND

• Fried 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.

  PMID: 11253156 BACKGROUND

• Khosravi 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.

  PMID: 26216463 BACKGROUND

• Lange-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.

  PMID: 25373610 BACKGROUND

• Lee 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.

  PMID: 29183379 BACKGROUND

• McPhee 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.

  PMID: 26936444 BACKGROUND

• Mundt 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.

  PMID: 31528238 BACKGROUND

• Panizzolo 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.

  PMID: 31615535 BACKGROUND

• Sawicki 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.

  PMID: 32075669 BACKGROUND

• Shin 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.

  PMID: 30389054 BACKGROUND

• Tramontano M, Morone G, Curcio A, Temperoni G, Medici A, Morelli D, Caltagirone C, Paolucci S, Iosa M. Maintaining gait stability during dual walking task: effects of age and neurological disorders. Eur J Phys Rehabil Med. 2017 Feb;53(1):7-13. doi: 10.23736/S1973-9087.16.04203-9. Epub 2016 Aug 30.

  PMID: 27575014 BACKGROUND

• Villumsen M, Grarup B, Christensen SWMP, Palsson TS, Hirata RP. "Study protocol for the >/=65 years NOrthern jutland Cohort of Fall risk Assessment with Objective measurements (the NOCfao study)". BMC Geriatr. 2020 Jun 8;20(1):198. doi: 10.1186/s12877-020-01535-6.

  PMID: 32513121 BACKGROUND

• Witte KA, Fiers P, Sheets-Singer AL, Collins SH. Improving the energy economy of human running with powered and unpowered ankle exoskeleton assistance. Sci Robot. 2020 Mar 25;5(40):eaay9108. doi: 10.1126/scirobotics.aay9108.

  PMID: 33022600 BACKGROUND

• Yandell MB, Tacca JR, Zelik KE. Design of a Low Profile, Unpowered Ankle Exoskeleton That Fits Under Clothes: Overcoming Practical Barriers to Widespread Societal Adoption. IEEE Trans Neural Syst Rehabil Eng. 2019 Apr;27(4):712-723. doi: 10.1109/TNSRE.2019.2904924. Epub 2019 Mar 14.

  PMID: 30872237 BACKGROUND

Related Links

• Danish Health Authority. Health promotion package - Physical activity. (2018).
• Sundhedsstyrelsen. Danskernes Sundhed - Tal fra Den Nationale Sundhedsprofil
• World Health Organization. Denmark Physical activity factsheet 2018
• 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 Safety

MeSH Terms

Interventions

Exoskeleton Device

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Cristina-Ioana Pirscoveanu

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 18, 2023
• Study Start: September 6, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)