AgingNCT04033146
Optimizing Ankle Exoskeleton Assistance for Walking Across the Life Span
A study testing Ankle Exoskeleton Assistance in people with Aging, run by Georgia Institute of Technology at 1 site in United States.
Trial summary
The investigators seek to determine whether ankle exoskeletons can reduce metabolic energy expenditure during walking for users across the age-spectrum. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Ankle Exoskeleton Assistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 23 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be able to walk for 60 minutes in a 90-minute time frame.
- Subjects are apparently free of cardiovascular, metabolic, and renal disease, which includes no signs or symptoms suggestive of cardiovascular, metabolic or renal disease.
- Subjects have no current musculoskeletal injury.
- Subjects need to be either 18-45 or 65+ years old.
- These criteria meet the American College of Sports Medicine's 2015 guidelines for participant health screening prior to joining a moderate or moderate-to-vigorous exercise protocol. (Riebe et al., 2015).
Who cannot join
- Have dementia or an inability to give informed consent
- Have a musculoskeletal injury or feel pain while walking
- Have a history of dizziness and/or balance problems
- Have cardiovascular, heart, metabolic, or renal disease, or respiratory problems
- Smoke cigarettes
- Asthma
Show all 17Show fewer
- Feel pain or discomfort in the chest, neck, jaw, arms during rest or exercise
- Have orthopnea or paroxysmal nocturnal dyspnea
- Have ankle edema
- Have palpitations or tachycardia
- Have a heart murmur
- Have had a heart attack
- Have diabetes
- Have a pace maker
- Have unusual shortness of breath with usual activities
- Are <18 or 46-64 years of age
- Do not speak or understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Physiology of Wearable Robotics Laboratory (Georgia Tech)
Atlanta, Georgia, 30332
About this study
The investigators seek to determine whether ankle exoskeletons can reduce metabolic energy expenditure during walking for users across the age-spectrum.
Read the detailed description
Older adults walk with greater metabolic rates than young adults. Growing evidence suggests that the greater older adult metabolic rates are related to the structural properties of their lower leg tissues. The tendons of the leg of older adults are more compliant than that of young adults. Accordingly, older adult leg tendons stretch more under a given load, such as during walking, causing their muscles to operate at shorter, less optimal lengths, and higher activity levels than the muscles of young adults - a less economical way to produces force.
Thus, the investigators seek to examine whether wearing wearable robotic boots (i.e., ankle exoskeletons) could enable muscles to produce force more economically. By adding an exoskeleton in-parallel to the ankle, the investigators hypothesize that older adults will walk with lower whole-body metabolic rate than without the exoskeleton assistance.
In this study, the investigators will have both young and older adult participants walk on a treadmill with a commercially available ankle exoskeleton set in multiple assistance modes. During these trials, the investigators will measure the metabolic cost of walking in young and older adults and also take many physiological and biomechanical measurements to help assess how exoskeletons work to reduce walking effort.
- Conditions
- Aging
- Being tested
- Ankle Exoskeleton Assistance
- Keywords
- Walking, Aging, Exoskeleton Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Exoskeleton AssistanceDevice
The investigators will use ankle-exoskeletons to modulate the amount of mechanical power generated by the user's ankle joint. That is, participants will walk in a robotic device that either (a) adds a spring or (b) a motor in parallel with their calf muscles to help them generate a stronger propulsive push-off that could reduce the effort of walking.
| Study group | Role | What they receive |
|---|---|---|
| Young Adult Exoskeleton Users | Experimental | Study participants who are 18-45 year old. Receives: Device: Ankle Exoskeleton Assistance |
| Older Adult Exoskeleton Users | Experimental | Study participants who are greater than 65 years of age. Receives: Device: Ankle Exoskeleton Assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Metabolic Rate (Watts/kg)
The rate of metabolic energy that participants expend during a short walking bout in each of the experimental conditions.
Measured: 3rd session, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start4 Feb 2020
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants will perform the same trials/sessions to complete the entire protocol. After each participant has performed all trials for this study, the investigators will analyze the data of this repeated-measures design.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Gregory S Sawicki, Ph.D., Principal investigator, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033146
- Sponsor's protocol ID
- H18208
- Other IDs
- F32AG063460
- Status last verified
- Jun 2024
- First submitted
- 23 Jul 2019
- Last updated
- 21 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Asbeck AT, De Rossi SM, Holt KG, and Walsh CJ. A biologically inspired soft exosuit for walking assistance. The international journal of robotics research 34: 744-762, 2015.
Biewener AA, Farley CT, Roberts TJ, Temaner M. Muscle mechanical advantage of human walking and running: implications for energy cost. J Appl Physiol (1985). 2004 Dec;97(6):2266-74. doi: 10.1152/japplphysiol.00003.2004. Epub 2004 Jul 16.
PubMed 15258124Browne MG, Franz JR. The independent effects of speed and propulsive force on joint power generation in walking. J Biomech. 2017 Apr 11;55:48-55. doi: 10.1016/j.jbiomech.2017.02.011. Epub 2017 Feb 21.
PubMed 28262285Cavagna GA, Kaneko M. Mechanical work and efficiency in level walking and running. J Physiol. 1977 Jun;268(2):467--81. doi: 10.1113/jphysiol.1977.sp011866.
PubMed 874922CAVAGNA GA, SAIBENE FP, MARGARIA R. MECHANICAL WORK IN RUNNING. J Appl Physiol. 1964 Mar;19:249-56. doi: 10.1152/jappl.1964.19.2.249. No abstract available.
PubMed 14155290Collins 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 25830889Csapo R, Malis V, Hodgson J, Sinha S. Age-related greater Achilles tendon compliance is not associated with larger plantar flexor muscle fascicle strains in senior women. J Appl Physiol (1985). 2014 Apr 15;116(8):961-9. doi: 10.1152/japplphysiol.01337.2013. Epub 2014 Feb 6.
PubMed 24505104DeVita P, Helseth J, Hortobagyi T. Muscles do more positive than negative work in human locomotion. J Exp Biol. 2007 Oct;210(Pt 19):3361-73. doi: 10.1242/jeb.003970.
PubMed 17872990DeVita P, Hortobagyi T. Age causes a redistribution of joint torques and powers during gait. J Appl Physiol (1985). 2000 May;88(5):1804-11. doi: 10.1152/jappl.2000.88.5.1804.
PubMed 10797145Elliott G, Sawicki GS, Marecki A, Herr H. The biomechanics and energetics of human running using an elastic knee exoskeleton. IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650418. doi: 10.1109/ICORR.2013.6650418.
PubMed 24187237Farris DJ, Sawicki GS. The mechanics and energetics of human walking and running: a joint level perspective. J R Soc Interface. 2012 Jan 7;9(66):110-8. doi: 10.1098/rsif.2011.0182. Epub 2011 May 25.
PubMed 21613286Ferris DP, Sawicki GS, Domingo A. Powered lower limb orthoses for gait rehabilitation. Top Spinal Cord Inj Rehabil. 2005;11(2):34-49. doi: 10.1310/6gl4-um7x-519h-9jyd.
PubMed 16568153Franz JR, Slane LC, Rasske K, Thelen DG. Non-uniform in vivo deformations of the human Achilles tendon during walking. Gait Posture. 2015 Jan;41(1):192-7. doi: 10.1016/j.gaitpost.2014.10.001. Epub 2014 Oct 12.
PubMed 25457482Gottschall JS, Kram R. Energy cost and muscular activity required for propulsion during walking. J Appl Physiol (1985). 2003 May;94(5):1766-72. doi: 10.1152/japplphysiol.00670.2002. Epub 2002 Dec 27.
PubMed 12506042Griffin TM, Tolani NA, Kram R. Walking in simulated reduced gravity: mechanical energy fluctuations and exchange. J Appl Physiol (1985). 1999 Jan;86(1):383-90. doi: 10.1152/jappl.1999.86.1.383.
PubMed 9887153
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Ankle Exoskeleton Assistance for Walking Across the Life Span
- ClinicalTrials.gov ID
- NCT04033146
- Acronym / sponsor ID
- H18208
- Conditions
- Aging
- Keywords
- Walking, Aging, Exoskeleton Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Posted 21 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators seek to determine whether ankle exoskeletons can reduce metabolic energy expenditure during walking for users across the age-spectrum.
Detailed description
Older adults walk with greater metabolic rates than young adults. Growing evidence suggests that the greater older adult metabolic rates are related to the structural properties of their lower leg tissues. The tendons of the leg of older adults are more compliant than that of young adults. Accordingly, older adult leg tendons stretch more under a given load, such as during walking, causing their muscles to operate at shorter, less optimal lengths, and higher activity levels than the muscles of young adults - a less economical way to produces force.
Thus, the investigators seek to examine whether wearing wearable robotic boots (i.e., ankle exoskeletons) could enable muscles to produce force more economically. By adding an exoskeleton in-parallel to the ankle, the investigators hypothesize that older adults will walk with lower whole-body metabolic rate than without the exoskeleton assistance.
In this study, the investigators will have both young and older adult participants walk on a treadmill with a commercially available ankle exoskeleton set in multiple assistance modes. During these trials, the investigators will measure the metabolic cost of walking in young and older adults and also take many physiological and biomechanical measurements to help assess how exoskeletons work to reduce walking effort.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will perform the same trials/sessions to complete the entire protocol. After each participant has performed all trials for this study, the investigators will analyze the data of this repeated-measures design.
| Arm | Type | Receives |
|---|---|---|
| Young Adult Exoskeleton Users | Experimental | Device: Ankle Exoskeleton AssistanceStudy participants who are 18-45 year old. |
| Older Adult Exoskeleton Users | Experimental | Device: Ankle Exoskeleton AssistanceStudy participants who are greater than 65 years of age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be able to walk for 60 minutes in a 90-minute time frame.
- Subjects are apparently free of cardiovascular, metabolic, and renal disease, which includes no signs or symptoms suggestive of cardiovascular, metabolic or renal disease.
- Subjects have no current musculoskeletal injury.
- Subjects need to be either 18-45 or 65+ years old.
- These criteria meet the American College of Sports Medicine's 2015 guidelines for participant health screening prior to joining a moderate or moderate-to-vigorous exercise protocol. (Riebe et al., 2015).
Key exclusion criteria (17 listed)
- Have dementia or an inability to give informed consent
- Have a musculoskeletal injury or feel pain while walking
- Have a history of dizziness and/or balance problems
- Have cardiovascular, heart, metabolic, or renal disease, or respiratory problems
- Smoke cigarettes
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 |
|---|---|---|
| Ankle Exoskeleton AssistanceThe investigators will use ankle-exoskeletons to modulate the amount of mechanical power generated by the user's ankle joint. That is, participants will walk in a robotic device that either (a) adds a spring or (b) a motor in parallel with their calf muscles to help them generate a stronger propulsive push-off that could reduce the effort of walking. | Device | Older Adult Exoskeleton Users, Young Adult Exoskeleton Users |
Primary outcome
Net Metabolic Rate (Watts/kg)
Time frame: 3rd session, up to 2 weeks
The rate of metabolic energy that participants expend during a short walking bout in each of the experimental conditions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAsbeck AT, De Rossi SM, Holt KG, and Walsh CJ. A biologically inspired soft exosuit for walking assistance. The international journal of robotics research 34: 744-762, 2015.
- Background: PubMed 15258124Biewener AA, Farley CT, Roberts TJ, Temaner M. Muscle mechanical advantage of human walking and running: implications for energy cost. J Appl Physiol (1985). 2004 Dec;97(6):2266-74. doi: 10.1152/japplphysiol.00003.2004. Epub 2004 Jul 16.
- Background: PubMed 28262285Browne MG, Franz JR. The independent effects of speed and propulsive force on joint power generation in walking. J Biomech. 2017 Apr 11;55:48-55. doi: 10.1016/j.jbiomech.2017.02.011. Epub 2017 Feb 21.
- Background: PubMed 874922Cavagna GA, Kaneko M. Mechanical work and efficiency in level walking and running. J Physiol. 1977 Jun;268(2):467--81. doi: 10.1113/jphysiol.1977.sp011866.
- Background: PubMed 14155290CAVAGNA GA, SAIBENE FP, MARGARIA R. MECHANICAL WORK IN RUNNING. J Appl Physiol. 1964 Mar;19:249-56. doi: 10.1152/jappl.1964.19.2.249. No abstract available.
- 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 24505104Csapo R, Malis V, Hodgson J, Sinha S. Age-related greater Achilles tendon compliance is not associated with larger plantar flexor muscle fascicle strains in senior women. J Appl Physiol (1985). 2014 Apr 15;116(8):961-9. doi: 10.1152/japplphysiol.01337.2013. Epub 2014 Feb 6.
- Background: PubMed 17872990DeVita P, Helseth J, Hortobagyi T. Muscles do more positive than negative work in human locomotion. J Exp Biol. 2007 Oct;210(Pt 19):3361-73. doi: 10.1242/jeb.003970.
- Background: PubMed 10797145DeVita P, Hortobagyi T. Age causes a redistribution of joint torques and powers during gait. J Appl Physiol (1985). 2000 May;88(5):1804-11. doi: 10.1152/jappl.2000.88.5.1804.
- Background: PubMed 24187237Elliott G, Sawicki GS, Marecki A, Herr H. The biomechanics and energetics of human running using an elastic knee exoskeleton. IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650418. doi: 10.1109/ICORR.2013.6650418.
- Background: PubMed 21613286Farris DJ, Sawicki GS. The mechanics and energetics of human walking and running: a joint level perspective. J R Soc Interface. 2012 Jan 7;9(66):110-8. doi: 10.1098/rsif.2011.0182. Epub 2011 May 25.
- Background: PubMed 16568153Ferris DP, Sawicki GS, Domingo A. Powered lower limb orthoses for gait rehabilitation. Top Spinal Cord Inj Rehabil. 2005;11(2):34-49. doi: 10.1310/6gl4-um7x-519h-9jyd.
- Individual participant dataSharing planned: No
Related trials for Aging
Not yet recruiting
Effects of Art-Based Group Reminiscence Therapy on Resilience and Joy of Living in Older Adults
Resilience, Psychological, Joy of Living
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
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.
Gregory S Sawicki, Ph.D. principal investigator
Georgia Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Exoskeleton Assistance in people with Aging, run by Georgia Institute of Technology at 1 site in United States.
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 5 inclusion and 17 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 21 Jun 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Net Metabolic Rate (Watts/kg) (time frame: 3rd session, up to 2 weeks). 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 NCT04033146, which also lists 37 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 21 Jun 2024.