Duluth, Minnesota 55812


Purpose:

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 summary:

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 by Ohata and colleagues (2018). 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).


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


NCT ID:

NCT03828214


Primary Contact:

Principal Investigator
Alexandra L Borstad, PhD
College of St. Scholastica

Alexandra L Borstad, PhD
Phone: 218-625-4938
Email: aborstad@css.edu


Backup Contact:

Email: jborstad1@css.edu
John D Borstad, PhD
Phone: 218-723-6523


Location Contact:

Duluth, Minnesota 55812
United States

Kathy King, BS
Phone: 218-723-6786
Email: kking@css.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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