Assistive Hip Exoskeleton Study for Stroke

NCT03924765 | Completed Results FDA Device

• 1 other identifier: H19179
• 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 with stroke 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 stroke 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; Stroke

Keywords

Exoskeleton

Outcome Measures

Primary Outcomes (1)

• Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance

  Using five different hip exoskeleton assistance strategies, the participant's overground self-selected walking speed was recorded. Assistance types are 1) Unilateral Paretic Assistance, 2) Unilateral Non-Paretic Assistance, 3) Bilateral Equal Assistance, 4) Bilateral Additional Paretic Assistance, and 5) Bilateral Additional Non-Paretic Assistance. The first information (unilateral or bilateral) refers to the leg(s) that the exoskeleton is providing assistance with. For example, unilateral assistance means that the assistance is provided to only one side (zero assistance for the other side). The second information (additional paretic/non-paretic or equal) refers to the leg that the assistance is provided more. For example, bilateral additional paretic assistance means that the exoskeleton is providing assistance to both hip joints but provides higher magnitude on the paretic side.

  4 hours

Secondary Outcomes (1)

• Step Length Asymmetry Using Hip Exoskeleton Assistance

  4 hours

Study Arms (1)

Individuals post-stroke using a powered hip exoskeleton

EXPERIMENTAL

This study will be conducted on a sample population of stroke 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 be testing a powered hip exoskeleton and its capability to improve locomotion in stroke survivors.

Individuals post-stroke using a powered hip exoskeleton

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-85 years
• Had stroke over 6 months prior
• Greater than 17 on minimental state examination (MMSE)
• Sit unsupported for a minimum of 30 seconds
• Follow a 3 step command.
• Ability to walk without support (a rail as needed is allowed), with a walking speed of at least 0.4 m/s (limited community ambulatory speed)
• Ability to walk for at least 6 minutes
• Willingness and ability to participate over a 1-4 hour experiment, with breaks enforced regularly and as needed
• Ability to transfer (sit-to-stand and stand-to-sit) with no external support (arm rests support allowed)
• Ability to ambulate over small slopes (3 degrees) and a few steps (6 steps)

You may not qualify if:

• Loss of sensation in the legs
• A complete spinal cord injury
• History of concussion in the last 6 months
• History of any severe cardiovascular conditions
• Severe arthritis
• Orthopedic problems that limit lower extremity passive range of motion (knee flexion contracture of \>10 degrees, knee flexion active ROM 15 degrees)
• Pre-existing neurological and other disorders such as Parkinson's disease, ALS, MS, dementia
• History of head trauma
• Lower extremity amputation
• Non-healing ulcers of a lower extremity
• Renal dialysis or end state liver disease
• Legal blindness or severe visual impairment
• Uses a pacemaker
• Has a metal implants in the head region
• Uses medications that lower seizure thresholds.

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; Stroke

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

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 Institute of Technology

  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: July 24, 2019
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: December 15, 2021
• Results First Posted: December 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)