Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton

NCT03828214 | Completed Results FDA Device

• 1 other identifier: 001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

exoskeleton; gait; kinematics; EMG; stair climbing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Lower Limb Electromyography (EMG)

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

• Ground Reaction Force at Terminal Stance

  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

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

Interventions

Robotic exoskeleton for walking assist DEVICE

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.

Eligibility Criteria

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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• College of St. Scholastica, Inc.: lead
• Honda Research and Development Americas: collaborator

Study Sites (1)

College of St. Scholastica-Health Science Center

Duluth, Minnesota, 55812, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Dr. Alexandra Borstad
• Organization: College of St. Scholastica

aborstad@css.edu

614-395-1708

Study Officials

• Alexandra L Borstad, PhD

  College of St. Scholastica

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: 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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Within-subject design

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 4, 2019
• Study Start: December 11, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2023-02

Locations

US (1)