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Completed

NCT Number: NCT04033146

Optimizing Ankle Exoskeleton Assistance for Walking Across the Life Span

The investigators seek to determine whether ankle exoskeletons can reduce metabolic energy expenditure during walking for users across the age-spectrum.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiology of Wearable Robotics Laboratory (Georgia Tech)

Atlanta, Georgia, 30332, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle Exoskeleton Assistance

Device

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Georgia Institute of Technology

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2019
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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