Clinical trial NCT03828214: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: exoskeleton
gait
kinematics
EMG
stair climbing
Lead sponsor: College of St. Scholastica, Inc.
Sponsor class: OTHER
Collaborators: name: Honda Research and Development Americas
First posted: 2019-02-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-subject design
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Gait Kinematics
timeFrame: Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.
Secondary outcomes:
measure: Lower Limb Electromyography (EMG)
timeFrame: Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.
measure: Ground Reaction Force at Terminal Stance
timeFrame: Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions.
measure: Stair Climbing Ascend/Descend Test
timeFrame: Stairs will be measured at a single time point (in one 2-hour session) for each participant
Other outcomes:
Locations:
city: Duluth
country: United States
facility: College of St. Scholastica-Health Science Center
state: Minnesota
Study officials:
affiliation: College of St. Scholastica
name: Alexandra L Borstad, PhD
role: PRINCIPAL_INVESTIGATOR
References: