Back to results

Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Robotic exoskeleton for walking assist

About this trial

This is an interventional basic science trial for Stroke focused on measuring exoskeleton, gait, kinematics, EMG, stair climbing

Eligibility Criteria

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

Inclusion Criteria:

≥12 weeks but <1 year post stroke at time of study participation
Age: 18-85 years
Ability to walk a minimum of 10 meters with standby assistance with or without orthosis or assistive device (Functional Ambulation categories 3, 4 or 5)
Able to follow three step commands
Express the ability to understand study tasks and purpose
Able and willing to provide written informed consent
Living in the community with the ability to travel to maurices Community Clinic for testing
Willingness to wear the StepWatch pedometer for a period of 3 days in their home
(If applicable) ≥ 90 days post major orthopedic surgery (such as a joint replacement)
(If applicable) ≥ 6 months post cardiac surgery

Exclusion Criteria:

Serious cardiac conditions (hospitalized for myocardial infarction or heart surgery within 3 months, congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
Severe arthritis or orthopedic conditions that limit lower extremity range of motion (> 10° or < 90° knee flexion, lacking > 25° hip extension, >15° from neutral plantar flexion.)
Preexisting neurologic disorders such as Dementia, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease or Ataxia.
History of lower limb amputation, non-healing ulcers, legal blindness or severe visual impairment

Sites / Locations

College of St. Scholastica-Health Science Center

Outcomes

Primary Outcome Measures

Gait Kinematics

Difference in affected leg maximum knee flexion angle (initial swing to midswing) between conditions Kinematic Analysis of Gait will be obtained using a Qualisys 8-camera motion capture system. Sample rate 120 Hz. A modified Istituti Ortopedici Rizzoli (IOR) gait marker set (~40 markers) applied bilaterally.

Secondary Outcome Measures

Lower Limb Electromyography (EMG)

Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz.

Ground Reaction Force at Terminal Stance

2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz.

Stair Climbing Ascend/Descend Test

A timed test of the ability to ascend and descend stairs with our without a rail. For this study a flight of 7 stairs will be used. The means of two trials of ascending and descending will be recorded. (Flansbjer et al., 2005)

Full Information

NCT ID

NCT03828214

First Posted

January 31, 2019

Last Updated

February 7, 2023

Sponsor

College of St. Scholastica, Inc.

Collaborators

Honda R and D Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03828214

Brief Title

Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton

Official Title

Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

December 11, 2018 (Actual)

Primary Completion Date

August 31, 2019 (Actual)

Study Completion Date

August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

College of St. Scholastica, Inc.

Collaborators

Honda R and D Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

To investigate the effect of a robotic exoskeleton on kinematics, muscle activity, ground reaction forces and spatiotemporal characteristics during walking in persons post stroke.

Detailed Description

Following stroke walking dysfunction is prevalent. Traditional rehabilitation methods fall short of achieving desirable walking outcomes for most people who experience stroke. Robotic methods to assist walking, such as the Honda Walking Assist Device (HWA) Robot from Honda R & D Americas Inc., are being explored as a means of improving the recovery of walking post stroke. Prior to examining the effectiveness of exoskeletal robots for walking recovery it is important to understand their effect on kinematic and muscle responses during walking. Kinematic and muscle responses at the hip during walking with the HWA were recently described. The purpose of this study is to quantify the effect of walking with the HWA on body segments remote from the hip. These segments include knee, ankle, trunk and arm. The non-invasive measures used will include: walking kinematics (measurement of joint angles using cameras), muscle activity (Electromyography), ground reaction forces (detected by a force plate in the floor) and spatiotemporal characteristics (such as walking speed). Measures will be collected under three conditions: 1) walking at self-selected pace (control), 2) walking at self-selected pace with the HWA (4 Newton-meter assist mode for hip flexion and extension), 3) walking immediately following HWA use (aftereffect).

6. Conditions and Keywords

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

Stroke

Keywords

exoskeleton, gait, kinematics, EMG, stair climbing

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Within-subject design

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Robotic exoskeleton for walking assist

Intervention Description

Participants will have two testing sessions in this within-subject design experiment. The conditions under which walking will be evaluated are control (normal) walking, walking with the exoskeleton assistance and walking immediately following exoskeleton walking. The conditions under which stair walking (ascending and descending) will be evaluated include control (normal) stairs and exoskeleton assisted stairs. Assistance is provided by The Honda Walking Assist (HWA) System is a robotic device developed by Honda R&D Corporation ®, Japan. The devices computer-activated motors use hip angle information to guide assistance delivered through the thigh straps to the legs in time with the walking cycle. The maximum torque delivered is 4 Newton-meters.

Primary Outcome Measure Information:

Title

Gait Kinematics

Description

Time Frame

Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.

Secondary Outcome Measure Information:

Title

Lower Limb Electromyography (EMG)

Description

Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz.

Time Frame

Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.

Title

Ground Reaction Force at Terminal Stance

Description

2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz.

Time Frame

Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions.

Title

Stair Climbing Ascend/Descend Test

Description

Time Frame

Stairs will be measured at a single time point (in one 2-hour session) for each participant

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: ≥12 weeks but <1 year post stroke at time of study participation Age: 18-85 years Ability to walk a minimum of 10 meters with standby assistance with or without orthosis or assistive device (Functional Ambulation categories 3, 4 or 5) Able to follow three step commands Express the ability to understand study tasks and purpose Able and willing to provide written informed consent Living in the community with the ability to travel to maurices Community Clinic for testing Willingness to wear the StepWatch pedometer for a period of 3 days in their home (If applicable) ≥ 90 days post major orthopedic surgery (such as a joint replacement) (If applicable) ≥ 6 months post cardiac surgery Exclusion Criteria: Serious cardiac conditions (hospitalized for myocardial infarction or heart surgery within 3 months, congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living) Severe arthritis or orthopedic conditions that limit lower extremity range of motion (> 10° or < 90° knee flexion, lacking > 25° hip extension, >15° from neutral plantar flexion.) Preexisting neurologic disorders such as Dementia, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease or Ataxia. History of lower limb amputation, non-healing ulcers, legal blindness or severe visual impairment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandra L Borstad, PhD

Organizational Affiliation

College of St. Scholastica

Official's Role

Principal Investigator

Facility Information:

Facility Name

College of St. Scholastica-Health Science Center

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55812

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton

We'll reach out to this number within 24 hrs