Powered Hip Exoskeleton Assistance Study

NCT03924752 | Completed Results FDA Device

• 1 other identifier: H19178
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The increased metabolic and biomechanical demands of ambulation limit community mobility in persons with lower limb disability due to neurological damage. There is a critical need for improving the locomotion capabilities of individuals who have walking impairments due to disease to increase their community mobility, independence, and health. Robotic exoskeletons have the potential to assist these individuals by increasing community mobility to improve quality of life. While these devices have incredible potential, current technology does not support dynamic movements common with locomotion such as transitioning between different gaits and supporting a wide variety of walking speeds. One significant challenge in achieving community ambulation with exoskeletons is providing an adaptive control system to accomplish a wide variety of locomotor tasks. Many exoskeletons today are developed without a detailed understanding of the effect of the device on the human musculoskeletal system. This research is interested in studying the question of how the control system affects human biomechanics including kinematic, kinetics and muscle activation patterns. By optimizing exoskeleton controllers based on human biomechanics and adapting control based on task, the biggest benefit to patient populations will be achieved to help advance the state-of-the-art with assistive hip exoskeletons.

Conditions

Lower Limb Injury

Keywords

Exoskeleton

Outcome Measures

Primary Outcomes (1)

• Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes

  Measure Description: The subject's preferred overground walking speed while wearing a powered hip exoskeleton was recorded. During walking, the exoskeleton provided hip assistance. There was a total of five walking conditions that were evaluated: 1) level-ground, 2) ramp ascent, 3) ramp descent, 4) stair ascent and 5) stair descent. The ramp incline was set to 9.2 degrees and the stair height was set to 15.24 cm. The user's preferred walking speed was calculated by looking at the distance traveled divided by time for a given walking condition. The distance was fixed and a completion time for each trial was recorded with a computer timer to calculate the average walking velocity for a given trial.

  4 hours

Study Arms (1)

Healthy individuals using powered exoskeleton

EXPERIMENTAL

This study will be conducted on a sample population of able-bodied subjects (single arm). Each subject will test with each condition of the exoskeleton (repeated measures).

Device: Powered hip exoskeleton

Interventions

Powered hip exoskeleton DEVICE

The study team will test a powered hip exoskeleton and its capability to improve locomotion.

Healthy individuals using powered exoskeleton

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18-85 years of age
• Subjects should be capable of walking, ascending/descending stairs and ramps with full capability in lower extremity passive range of motion (knee flexion contracture of \>10 degrees, knee flexion ROM \< 90 degrees, hip flexion contracture \< 25 degrees, and ankle plantar flexion contracture of \>15 degrees).
• Subjects must be able to walk for at least 5 minutes and willing and able to participate over a 1-6 hours experiment with breaks and rest enforced regularly and as needed.
• Subjects must be able to transfer (sit-to-stand and stand-to-sit) with no external support (arm rests OK) and to ambulate over small slopes (3 degrees) and a few steps (6 steps).

You may not qualify if:

• History of neurological injury, gait pathology, or cardiovascular condition that would limit your ability to ambulate for multiple hours.

Sponsors & Collaborators

• Georgia Institute of Technology: lead

Study Sites (1)

Exoskeleton and Prosthetic Intelligent Controls Lab

Atlanta, Georgia, 30332, United States

Location

MeSH Terms

Conditions

Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Dr. Aaron Young
• Organization: Georgia Institute of Technology

aaron.young@me.gatech.edu

404-385-5306

Study Officials

• Aaron Young, Ph.D.

  Georgia Tech

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The model used is a repeated measures single arm study. Multiple conditions including using and not using the device will be tested on the same subjects to have multiple test points on a per subject basis.

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 23, 2019
• Study Start: February 13, 2021
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: February 8, 2022
• Results First Posted: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)