Optimizing Ankle Exoskeleton Assistance for Walking Across the Life Span

NCT04033146 | Completed Results FDA Device

• 2 other identifiers: H18208F32AG063460
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aging

Keywords

Walking; Aging; Exoskeleton Device

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Young Adult Exoskeleton Users

EXPERIMENTAL

Study participants who are 18-45 year old.

Device: Ankle Exoskeleton Assistance

Older Adult Exoskeleton Users

EXPERIMENTAL

Study participants who are greater than 65 years of age.

Device: Ankle Exoskeleton Assistance

Interventions

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.

Older Adult Exoskeleton Users; Young Adult Exoskeleton Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia Institute of Technology: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Physiology of Wearable Robotics Laboratory (Georgia Tech)

Atlanta, Georgia, 30332, United States

Location

Related Publications (37)

• 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.

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Results Point of Contact

• Title: Dr. Gregory S. Sawicki; Professor Mechanical Engineering
• Organization: Georgia Insitute of Technology

gregory.sawicki@me.gatech.edu

919 448 5099

Study Officials

• Gregory S Sawicki, Ph.D.

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: February 4, 2020
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)