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| ID | Type | Description | Link |
|---|---|---|---|
| F32AG063460 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young Adult Exoskeleton Users | Experimental | Study participants who are 18-45 year old. |
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| Older Adult Exoskeleton Users | Experimental | Study participants who are greater than 65 years of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Net Metabolic Rate (Watts/kg) | The rate of metabolic energy that participants expend during a short walking bout in each of the experimental conditions. | 3rd session, up to 2 weeks |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory S Sawicki, Ph.D. | Georgia Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physiology of Wearable Robotics Laboratory (Georgia Tech) | Atlanta | Georgia | 30332 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 15258124 | Background | 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. | |
| 28262285 |
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Participants were enrolled and participated in the study from 2/4/2020 to 5/23/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Young Adult Exoskeleton Users | Study participants who are 18-45 year old. |
| FG001 | Older Adult Exoskeleton Users | Study participants who are >65 years old |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Young Adult Exoskeleton Users | Study participants who are 18-45 year old. |
| BG001 | Older Adult Exoskeleton Users | Study participants who are >65 years old |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | watts/kg | 3rd session, up to 2 weeks |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Young Adult Exoskeleton Users | Study participants who are 18-45 year old. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory S. Sawicki; Professor Mechanical Engineering | Georgia Insitute of Technology | 919 448 5099 | gregory.sawicki@me.gatech.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2024 | Apr 26, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2024 | Apr 26, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2023 | Jan 23, 2024 | ICF_000.pdf |
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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.
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|
| Background |
| Browne 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. |
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| 25830889 | 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. |
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| 25457482 | Background | Franz 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. |
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| 23418524 | Background | Malcolm P, Derave W, Galle S, De Clercq D. A simple exoskeleton that assists plantarflexion can reduce the metabolic cost of human walking. PLoS One. 2013;8(2):e56137. doi: 10.1371/journal.pone.0056137. Epub 2013 Feb 13. |
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| Background | Nuckols Rich DT, Sawicki Greg. Ultrasound measurements link soleus muscle dynamics and metabolic cost during human walking with elastic ankle exoskeletons. In Prep. |
| 16455811 | Background | Onambele GL, Narici MV, Maganaris CN. Calf muscle-tendon properties and postural balance in old age. J Appl Physiol (1985). 2006 Jun;100(6):2048-56. doi: 10.1152/japplphysiol.01442.2005. Epub 2006 Feb 2. |
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| 27417976 | Background | Takahashi KZ, Gross MT, van Werkhoven H, Piazza SJ, Sawicki GS. Adding Stiffness to the Foot Modulates Soleus Force-Velocity Behaviour during Human Walking. Sci Rep. 2016 Jul 15;6:29870. doi: 10.1038/srep29870. |
| 25889283 | Background | Takahashi KZ, Lewek MD, Sawicki GS. A neuromechanics-based powered ankle exoskeleton to assist walking post-stroke: a feasibility study. J Neuroeng Rehabil. 2015 Feb 25;12:23. doi: 10.1186/s12984-015-0015-7. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Study participants who are greater than 65 years of age.
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.
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|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Older Adult Exoskeleton Users | Study participants who are greater than 65 years of age. 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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