StrokeNCT03222505
Walk Assist Device to Improve Community Ambulation
A study testing Honda Stride Assist Device ON and No Device Worn in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The goal of this research study was to examine the immediate effects of a prototype wearable robotic stride management assist device (SMA) designed by Honda R\&D® on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Honda Stride Assist Device ON and No Device Worn
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke subjects with a history of unilateral, supratentorial, ischemic or hemorrhage stroke will be recruited, with lesion location confirmed by radiographic findings.
- All subjects who score > 10 on the Lower Extremity Motor Score (LEMS) developed previously to measure strength in Spinal Cord Injury (SCI). For the LEMS criteria, preliminary data indicate that subjects with LEMS < 10 in the chronic stages do not recover walking.
- All subjects will be required to walk > 10 m over ground without physical assistance at self-selected walking speeds ≤ 0.8 m/s using assistive devices and bracing below the knee as needed. A criterion of 0.8 m/s is utilized to target participants with limited or minimal ambulation in the community. Subjects will be further stratified into those who walk < 0.4 m/s and > 0.4 m/s, identified as household vs. limited community ambulators, respectively.
- Range of motion (ankle: -10 to 30 deg, knee: 0 to 90 deg, hip: -10 to 40 deg) consistent with gait;
- Medically stable with medical clearance to participate (absence of concurrent illness, including unhealed decubiti, infection, cardiopulmonary disease, osteoporosis, active heterotrophic ossification or peripheral nerve damage in the lower limbs, history of traumatic head injury);
- Able to tolerate 30 minutes of upright (standing) position without orthostasis (decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic; minimized with ambulatory population);
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- Must not be undergoing concurrent physical therapy to eliminate effects of additional interventions;
- Patients prescribed medications for spasticity will not be excluded from participation but will be asked to maintain current levels of medication or inform the researcher if changes are necessary.
- -
Who cannot join
- Women of childbearing potential will not be excluded, although women who are pregnant will be excluded due to potential forces at trunk from body weight support or pelvic assistance;
- Significant cardiorespiratory or metabolic disease that may limit exercise participation.
- Weights limit > 250 lbs (limit of most counter-weight safety systems).
- History of previous orthopedic or neurological conditions which may impair walking.
- Exclusion for TMS: pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, and pregnancy.
- Subjects with scores < 23 on the Mini Mental Status Exam will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
Official title: Development of Walk Assist Device to Improve Community Ambulation
The goal of this research study was to examine the immediate effects of a prototype wearable robotic stride management assist device (SMA) designed by Honda R\&D® on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.
Read the detailed description
The goal of this research study was to examine the immediate effectiveness of a prototype wearable robotic stride management assist device (SMA) designed by Honda R\&D on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.
The SMA assists walking by providing a flexion and extension torque assist at the hip joint. The subjects in this study are asked to perform two sets of experiments: one set with the device on and one set with the device turned off. The order in which the subjects performed these sets of experiments is selected randomly. Each set of experiments includes over-ground walking speed and endurance tests, a graded treadmill test with metabolic measures, motion capture and force treadmill analysis, and measures of corticospinal drive using transcranial magnetic stimulation (TMS). The primary outcome to be measured is change in self-selected walking speed with the device on, the secondary outcome measures include metabolic, corticospinal and biomechanical analysis.
- Conditions
- Stroke
- Being tested
- Honda Stride Assist Device ON, No Device Worn
- Keywords
- Stroke, Gait Stride Management Assist, Stroke, post 1 year or longer
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honda Stride Assist Device ONDevice
Subjects performed assessments of walking and motor performance while wearing the Honda Stride Assist Device.
No Device WornOther
Subjects performed assessments of walking and motor performance without wearing the Honda Assist Device.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill | Experimental | Not described Receives: Device: Honda Stride Assist Device ON; Other: No Device Worn |
| Overground Walking | Experimental | Not described Receives: Device: Honda Stride Assist Device ON; Other: No Device Worn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled
The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are "Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed."
Measured: Day 1
Change in Peak Treadmill (TM) Velocity Between Device Turned ON and OFF - Self Selected Walking Speed
Peak treadmill (TM) velocity: subjects walked on motorized treadmill with harness but no Body Weight Support (BWS). Testing started at 0.5 km/h and was increased in 0.5 km/h increments every 3 minutes until peak TM speed was achieved (identified as ability to sustain speed for ≥1min without stopping the treadmill).
Measured: Day 1
Secondary outcomes (2)
Percent Change in Excitability of Transcranial Magnetic Stimulation (TMS) Rectus Femoris (RF) Between Device ON and Device OFF
TMS measurements will involve generating motor evoked potentials (MEP) for each muscle from two different coil positions - 2cm on either side of the vertex. Motor evoked potentials (MEPs) at intensities ranging from 70 - 140% active threshold will be generated for each muscle from each coil position. TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. A positive percent change in excitability indicates higher excitability in the device-on condition. A negative percent change in excitability indicates higher excitability in the device-off condition.
Measured: Day 1
Change in Percent Excitability of Transcranial Magnetic Stimulation (TMS), Dorsiflexor Tibialis Anterior (TA) Between Device ON and Device OFF
TMS measurements will involve generating motor evoked potentials (MEP) for each muscle from two different coil positions - 2cm on either side of the vertex. Motor evoked potentials (MEPs) at intensities ranging from 70 - 140% active threshold will be generated for each muscle from each coil position. TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. A positive percent change in excitability indicates higher excitability in the device-on condition. A negative percent change in excitability indicates higher excitability in the device-off condition.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startJan 2010
- Primary completionMay 2018
- Study completionMay 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222505
- Sponsor's protocol ID
- NUSTU00022438
- Status last verified
- Aug 2019
- First submitted
- 22 Jun 2017
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Walk Assist Device to Improve Community Ambulation
- ClinicalTrials.gov ID
- NCT03222505
- Acronym / sponsor ID
- NUSTU00022438
- Conditions
- Stroke
- Keywords
- Stroke, Gait Stride Management Assist, Stroke, post 1 year or longer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study was to examine the immediate effects of a prototype wearable robotic stride management assist device (SMA) designed by Honda R\&D® on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.
Detailed description
The goal of this research study was to examine the immediate effectiveness of a prototype wearable robotic stride management assist device (SMA) designed by Honda R\&D on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.
The SMA assists walking by providing a flexion and extension torque assist at the hip joint. The subjects in this study are asked to perform two sets of experiments: one set with the device on and one set with the device turned off. The order in which the subjects performed these sets of experiments is selected randomly. Each set of experiments includes over-ground walking speed and endurance tests, a graded treadmill test with metabolic measures, motion capture and force treadmill analysis, and measures of corticospinal drive using transcranial magnetic stimulation (TMS). The primary outcome to be measured is change in self-selected walking speed with the device on, the secondary outcome measures include metabolic, corticospinal and biomechanical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill | Experimental | Device: Honda Stride Assist Device ON, Other: No Device Worn |
| Overground Walking | Experimental | Device: Honda Stride Assist Device ON, Other: No Device Worn |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stroke subjects with a history of unilateral, supratentorial, ischemic or hemorrhage stroke will be recruited, with lesion location confirmed by radiographic findings.
- All subjects who score > 10 on the Lower Extremity Motor Score (LEMS) developed previously to measure strength in Spinal Cord Injury (SCI). For the LEMS criteria, preliminary data indicate that subjects with LEMS < 10 in the chronic stages do not recover walking.
- All subjects will be required to walk > 10 m over ground without physical assistance at self-selected walking speeds ≤ 0.8 m/s using assistive devices and bracing below the knee as needed. A criterion of 0.8 m/s is utilized to target participants with limited or minimal ambulation in the community. Subjects will be further stratified into those who walk < 0.4 m/s and > 0.4 m/s, identified as household vs. limited community ambulators, respectively.
- Range of motion (ankle: -10 to 30 deg, knee: 0 to 90 deg, hip: -10 to 40 deg) consistent with gait;
- Medically stable with medical clearance to participate (absence of concurrent illness, including unhealed decubiti, infection, cardiopulmonary disease, osteoporosis, active heterotrophic ossification or peripheral nerve damage in the lower limbs, history of traumatic head injury);
Key exclusion criteria (6 listed)
- Women of childbearing potential will not be excluded, although women who are pregnant will be excluded due to potential forces at trunk from body weight support or pelvic assistance;
- Significant cardiorespiratory or metabolic disease that may limit exercise participation.
- Weights limit > 250 lbs (limit of most counter-weight safety systems).
- History of previous orthopedic or neurological conditions which may impair walking.
- Exclusion for TMS: pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, and pregnancy.
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 |
|---|---|---|
| Honda Stride Assist Device ONSubjects performed assessments of walking and motor performance while wearing the Honda Stride Assist Device. | Device | Overground Walking, Treadmill |
| No Device WornSubjects performed assessments of walking and motor performance without wearing the Honda Assist Device. | Other | Overground Walking, Treadmill |
Primary outcome
Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled
Time frame: Day 1
The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are "Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed."
Change in Peak Treadmill (TM) Velocity Between Device Turned ON and OFF - Self Selected Walking Speed
Time frame: Day 1
Peak treadmill (TM) velocity: subjects walked on motorized treadmill with harness but no Body Weight Support (BWS). Testing started at 0.5 km/h and was increased in 0.5 km/h increments every 3 minutes until peak TM speed was achieved (identified as ability to sustain speed for ≥1min without stopping the treadmill).
2 secondary outcomes
Percent Change in Excitability of Transcranial Magnetic Stimulation (TMS) Rectus Femoris (RF) Between Device ON and Device OFF
Time frame: Day 1
Change in Percent Excitability of Transcranial Magnetic Stimulation (TMS), Dorsiflexor Tibialis Anterior (TA) Between Device ON and Device OFF
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- 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.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honda Stride Assist Device ON and No Device Worn in people with Stroke, run by Shirley Ryan AbilityLab 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 9 inclusion and 6 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 28 Aug 2019. 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 28 Aug 2019). 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?
Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled (time frame: Day 1). The study lists 2 primary outcomes in all. 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 28 Aug 2019.