An interventional study of Ankle Exoskeleton Assistance in Aging, sponsored by Georgia Institute of Technology. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Georgia Institute of Technology · Not applicable, Interventional, and Basic science
The investigators seek to determine whether ankle exoskeletons can reduce metabolic energy expenditure during walking for users across the age-spectrum.
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.
Georgia Institute of Technology is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Study participants who are 18-45 year old.
Device: Ankle Exoskeleton Assistance
Study participants who are greater than 65 years of age.
Device: Ankle 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.
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
Participants were enrolled and participated in the study from 2/4/2020 to 5/23/2023.
| Milestone | Young Adult Exoskeleton Users | Older Adult Exoskeleton Users |
|---|---|---|
| Started | 10 | 6 |
| Completed | 10 | 6 |
| Not completed | 0 | 0 |
The rate of metabolic energy that participants expend during a short walking bout in each of the experimental conditions.
| watts/kg | Young Adult Exoskeleton Users | Older Adult Exoskeleton Users |
|---|---|---|
| No Exoskeleton | 3.30 ± 0.66 | 3.47 ± 0.31 |
| No Torque | 3.86 ± 0.62 | 4.18 ± 0.62 |
| Spring-like Torque | 3.72 ± 0.78 | 4.34 ± 0.57 |
| Motor-like Low Torque | 3.51 ± 0.83 | 3.68 ± 0.65 |
| Motor-like Medium Torque | 3.13 ± 0.70 | 3.46 ± 0.56 |
| Motor-like High Torque | 3.24 ± 0.65 | 3.20 ± 0.52 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Young Adult Exoskeleton Users | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Older Adult Exoskeleton Users | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Young Adult Exoskeleton Users | Older Adult Exoskeleton Users | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 0 | 10 |
| >=65 years | 0 | 6 | 6 |
| Sex: Female, Male(Participants) | Young Adult Exoskeleton Users | Older Adult Exoskeleton Users | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 7 | 1 | 8 |
| Race and Ethnicity Not Collected(Participants) | Young Adult Exoskeleton Users | Older Adult Exoskeleton Users | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Georgia Institute of Technology