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Optimizing Ankle Exoskeleton Assistance for Walking Across the Life Span

Optimizing Ankle Exoskeleton Assistance for Walking Across the Life Span

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04033146
Enrollment
16
Registered
2019-07-25
Start date
2020-02-04
Completion date
2023-05-23
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

Walking, Aging, Exoskeleton Device

Brief summary

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.

Interventions

DEVICEAnkle Exoskeleton Assistance

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Georgia Institute of Technology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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).

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Net Metabolic Rate (Watts/kg)3rd session, up to 2 weeksThe rate of metabolic energy that participants expend during a short walking bout in each of the experimental conditions.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled and participated in the study from 2/4/2020 to 5/23/2023.

Participants by arm

ArmCount
Young Adult Exoskeleton Users
Study participants who are 18-45 year old.
10
Older Adult Exoskeleton Users
Study participants who are \>65 years old
6
Total16

Baseline characteristics

CharacteristicYoung Adult Exoskeleton UsersOlder Adult Exoskeleton UsersTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants6 Participants6 Participants
Age, Categorical
Between 18 and 65 years
10 Participants0 Participants10 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
3 Participants5 Participants8 Participants
Sex: Female, Male
Male
7 Participants1 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 6
other
Total, other adverse events
0 / 100 / 6
serious
Total, serious adverse events
0 / 100 / 6

Outcome results

Primary

Net Metabolic Rate (Watts/kg)

The rate of metabolic energy that participants expend during a short walking bout in each of the experimental conditions.

Time frame: 3rd session, up to 2 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Young Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)No Exoskeleton3.30 watts/kgStandard Deviation 0.66
Young Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)No Torque3.86 watts/kgStandard Deviation 0.62
Young Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)Spring-like Torque3.72 watts/kgStandard Deviation 0.78
Young Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)Motor-like Low Torque3.51 watts/kgStandard Deviation 0.83
Young Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)Motor-like Medium Torque3.13 watts/kgStandard Deviation 0.7
Young Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)Motor-like High Torque3.24 watts/kgStandard Deviation 0.65
Older Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)Motor-like Medium Torque3.46 watts/kgStandard Deviation 0.56
Older Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)No Exoskeleton3.47 watts/kgStandard Deviation 0.31
Older Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)Motor-like Low Torque3.68 watts/kgStandard Deviation 0.65
Older Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)No Torque4.18 watts/kgStandard Deviation 0.62
Older Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)Motor-like High Torque3.20 watts/kgStandard Deviation 0.52
Older Adult Exoskeleton UsersNet Metabolic Rate (Watts/kg)Spring-like Torque4.34 watts/kgStandard Deviation 0.57
Comparison: H1. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for young adults.~H2. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for older adults.p-value: <0.001ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026