Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Robotic exoskeleton for walking assist

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).

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Duluth, Minnesota, United States, 55812
      • College of St. Scholastica-Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.
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.	Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions.
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)	Stairs will be measured at a single time point (in one 2-hour session) for each participant

Collaborators and Investigators

• Sponsor: College of St. Scholastica, Inc.
• Collaborators: Honda R and D Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: gait; EMG; exoskeleton; kinematics; stair climbing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 001 (NavyGHB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No