StrokeNCT03828214
Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton
A study testing Robotic exoskeleton for walking assist in people with Stroke, run by College of St. Scholastica, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic exoskeleton for walking assist
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
College of St. Scholastica-Health Science Center
Duluth, Minnesota, 55812
About this study
To investigate the effect of a robotic exoskeleton on kinematics, muscle activity, ground reaction forces and spatiotemporal characteristics during walking in persons post stroke.
Read the 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).
- Conditions
- Stroke
- Being tested
- Robotic exoskeleton for walking assist
- Keywords
- exoskeleton, gait, kinematics, EMG, stair climbing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic exoskeleton for walking assistDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.
Secondary outcomes (3)
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: 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.
Measured: 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)
Measured: Stairs will be measured at a single time point (in one 2-hour session) for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start11 Dec 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject design
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- College of St. Scholastica, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Honda Research and Development Americas
- Responsible party
- Principal investigator, Alexandra Borstad, College of St. Scholastica, Inc.
- Investigators
- Alexandra L Borstad, PhD, Principal investigator, College of St. Scholastica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828214
- Sponsor's protocol ID
- 001
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2019
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton
- ClinicalTrials.gov ID
- NCT03828214
- Acronym / sponsor ID
- 001
- Conditions
- Stroke
- Keywords
- exoskeleton, gait, kinematics, EMG, stair climbing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- College of St. Scholastica, Inc.University, hospital or other
- Collaborators
- Honda Research and Development Americas
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Within-subject design
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic exoskeleton for walking assistParticipants 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. | Device | – |
Primary outcome
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.
3 secondary outcomes
Lower Limb Electromyography (EMG)
Time frame: Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.
Ground Reaction Force at Terminal Stance
Time frame: 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
Time frame: Stairs will be measured at a single time point (in one 2-hour session) for each participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra L Borstad, PhD principal investigator
College of St. Scholastica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic exoskeleton for walking assist in people with Stroke, run by College of St. Scholastica, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Kinematics (time frame: Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.