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Clinical Trials/NCT03828214
NCT03828214
Completed
N/A

Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton

College of St. Scholastica, Inc.1 site in 1 country11 target enrollmentDecember 11, 2018
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
College of St. Scholastica, Inc.
Enrollment
11
Locations
1
Primary Endpoint
Gait Kinematics
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 11, 2018
End Date
August 31, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
College of St. Scholastica, Inc.
Responsible Party
Principal Investigator
Principal Investigator

Alexandra Borstad

Associate Professor

College of St. Scholastica, Inc.

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

Outcomes

Primary Outcomes

Gait Kinematics

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

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 Outcomes

  • 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)

Study Sites (1)

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