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Adaptive Hip Exoskeleton for Stroke Gait Enhancement

Primary Purpose

Stroke

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Robotic hip exoskeleton

About this trial

This is an interventional basic science trial for Stroke focused on measuring Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Previous history of stroke with a physician's approval to safely perform the experimental activities.
The stroke must have occurred at least 6 months prior to study involvement.
Aged between 18-85 years of age.
Score greater than 17 on the mini-mental state examination (MMSE).
Able to sit unsupported for minimum of 30 seconds.
Able to follow a 3 step command.
Must be able 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).
Must be able to walk for at least 6 minutes.
Must be willing and able to participate in a 1-4 hour experiment, with breaks enforced regularly and as needed .
Must be able to transfer (sit-to-stand and stand-to-sit) with no external support (arm rests support allowed).
Must be able to ambulate over small slopes (3 degrees) and a few steps (6 steps).

Exclusion Criteria:

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, or orthopedic problems that would limit full participation in the study.
Diagnosis of other neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, history of head trauma which is not fully resolved (per participant report), lower extremity amputation, non-healing ulcers of a lower extremity, renal dialysis or end state liver disease, legal blindness or severe visual impairment.
Use of a pacemaker or have metal implants in the head region or medications that lower seizure thresholds.
Lastly, if you are participating in another clinical study and/or your physical condition is limited to do different tasks, in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results, you will be excluded from the study.

Sites / Locations

Exoskeleton and Prosthetic Intelligent Controls Lab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Powered Hip Exoskeleton for Stroke Assistance

Arm Description

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).

Outcomes

Primary Outcome Measures

Self-Selected Walking Speed

This measures the individuals preferred overground walking speed which indicates their physical capability with a device.

Secondary Outcome Measures

Full Information

NCT ID

NCT05536739

First Posted

September 8, 2022

Last Updated

September 11, 2023

Sponsor

Georgia Institute of Technology

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT05536739

Brief Title

Adaptive Hip Exoskeleton for Stroke Gait Enhancement

Official Title

Powered Hip Exoskeleton for Stroke Survivors With Gait Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2026 (Anticipated)

Primary Completion Date

April 30, 2027 (Anticipated)

Study Completion Date

July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Georgia Institute of Technology

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This work will focus on new algorithms for robotic exoskeletons and testing these in human subject tests. Individuals who have previously had a stroke will walk while wearing a robotic exoskeleton on a specialized treadmill. The study will compare the performance of the advanced algorithm with not using the device to determine the clinical benefit.

Detailed Description

The focus of this work is a proposed novel artificial intelligence (AI) system to self-adapt control policy in powered exoskeletons to aid deployment systems that personalize to individual patient gait. The investigators hypothesize that walking speed will improve with the use of the self-adaptive control policy system. Individuals post stroke have a broad range of mobility challenges including asymmetric gait, substantially decreased SSWS, and reduced stability, and therefore have greatly impaired overall mobility independence in the community. The investigators expect the proposed novel controller, capable of personalization to such variable and asymmetric gait patterns, will have significant benefits towards increasing community independence and mobility for patients post stroke. 12 patients post stroke will be fit with the hip exoskeleton and proceed to walk at varying speeds and inclines on a Motek CAREN system while the investigators measure self-selected walking speed. The self-adaptive system will be compared directly to a best-on-average control policy (non-adaptive) as well as to a 'standard of care' baseline. This baseline will be walking with no exoskeleton plus any clinically prescribed passive orthoses. The investigators expect the self-adaptive system to learn the control policy that best matches the patient's gait patterns, thus yielding advantages in walking speed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The model used is a repeated measures single arm study

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Powered Hip Exoskeleton for Stroke Assistance

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Robotic hip exoskeleton

Intervention Description

The intervention is an experimental robotic hip exoskeleton that has been previously developed by the team. It is used to improve walking gait performance.

Primary Outcome Measure Information:

Title

Self-Selected Walking Speed

Description

This measures the individuals preferred overground walking speed which indicates their physical capability with a device.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Previous history of stroke with a physician's approval to safely perform the experimental activities. The stroke must have occurred at least 6 months prior to study involvement. Aged between 18-85 years of age. Score greater than 17 on the mini-mental state examination (MMSE). Able to sit unsupported for minimum of 30 seconds. Able to follow a 3 step command. Must be able 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). Must be able to walk for at least 6 minutes. Must be willing and able to participate in a 1-4 hour experiment, with breaks enforced regularly and as needed . Must be able to transfer (sit-to-stand and stand-to-sit) with no external support (arm rests support allowed). Must be able to ambulate over small slopes (3 degrees) and a few steps (6 steps). Exclusion Criteria: 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, or orthopedic problems that would limit full participation in the study. Diagnosis of other neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, history of head trauma which is not fully resolved (per participant report), lower extremity amputation, non-healing ulcers of a lower extremity, renal dialysis or end state liver disease, legal blindness or severe visual impairment. Use of a pacemaker or have metal implants in the head region or medications that lower seizure thresholds. Lastly, if you are participating in another clinical study and/or your physical condition is limited to do different tasks, in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results, you will be excluded from the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aaron Young, Ph.D.

Phone

404-385-5306

aaron.young@me.gatech.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kinsey R Herrin, MSPO, C/LPO

Phone

470-578-7600

kinsey.herrin@me.gatech.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aaron Young, Ph.D.

Organizational Affiliation

Georgia Institute of Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Exoskeleton and Prosthetic Intelligent Controls Lab

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30332

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Adaptive Hip Exoskeleton for Stroke Gait Enhancement

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