StrokeNCT06374706
Effects of Rehabilitation Robots-Morning Walk in Individuals With Hemiparesis
A study testing Morning Walk training for stroke and Morning Walk training for healthy in people with Stroke and Healthy Volunteers, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Healthy Volunteers
- What is being tested?
- Morning Walk training for stroke and Morning Walk training for healthy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2024to 24 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For this study, twenty volunteers fulfilling the inclusion criteria from participating physical therapy facilities and the local community will be recruited. The criteria for participants with a history of stroke include: Age 20 or older.
- Experienced a unilateral first stroke, either ischemic or hemorrhagic, in the carotid artery distribution.
- Diagnosed with stroke at least one month prior to participating in the study.
- Free from major post-stroke complications, such as recurrent stroke, hip fracture, or myocardial infarction.
- Residing within the community.
- Capable of ambulating 10 meters with or without the use of assistive devices.
Who cannot join
- Stroke secondary to subarachnoid hemorrhage or posterior circulation stroke.
- Life expectancy of less than one year.
- Comatose state.
- Inability to follow 3-step commands.
- Amputation.
- Poorly controlled diabetes, exemplified by conditions such as foot ulceration.
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- Blindness.
- Progressive neurological diseases.
- Comprehensive aphasia.
- Medical instability.
- Significant musculoskeletal problems.
- Congestive cardiac failure.
- Unstable angina.
- Peripheral vascular disease.
- Neuropsychiatric disorders, including dementia, cognitive deficits, and severe depression.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis
In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards.
Read the detailed description
Total forty participants (20 stroke vs 20 healthy individuals) will sign a consent form that is pre-approved by the Institutional Review Board at the participating facilities, which states the purpose of the study, an explanation of the procedures, benefits and risks for the participant, a confidentiality statement, and a refusal/withdrawal policy.
This study will assess the feasibility of end-effector rehabilitation robots, specifically Morning Walk®, to optimize training outcomes and improve symmetry in individuals with stroke.
- Access the severity of functional and balance capacity prior to gait training. Stroke or healthy participants will first be asked questions about their medical history, physical functionality, and overall well-being. Participants will be equipped with an armband or chest strap to monitor their heart rate. Functional capacity will be assessed using walking tests on the Zeno Walkway system, which evaluates gait speed and spatiotemporal gait parameters during overground walking trials. During the testing process, participants will be recorded on video.
- Develop the training protocol for the end-effector rehabilitation robot, Morning Walk. Prior to the end-effector robot training, Investigators will attach six Delsys wireless electromyographic sensors (Delsys Inc, Natick, MA) to analyze muscle activity in the lower extremities. Additionally, stroke or healthy participants will be equipped with the Tekscan In-Shoes system (Tekscan, Inc., South Boston) to assess temporal events related to foot positioning during training, such as limb loading time. During the end-effector robot training, a saddle-type weight support and secure strap system will be employed to prevent loss of balance or falls. Following an appropriate warm-up and familiarization with the end-effector robot training, various walking parameters of Morning Walk, such as pace, stride length, step height, and initial contact angle, will be examined to achieve balanced loading times between the paretic and non-paretic sides in stroke participants. Training parameters such as step length, step height, and joint angle can be independently adjusted for the paretic and non-paretic sides in stroke patients, and for the dominant and non-dominant sides in healthy individuals. This approach allows for the restriction of movement in the non-paretic or non-dominant side, thereby encouraging the activity of the paretic or dominant side during training. The adaptation training parameters will be adjusted according to the participant's walking capacity. During the training session, participants will be recorded on video.
- Assessing the Immediate Post-Adaptation Effect of Morning Walk Training on the Ground.
Stroke or healthy participants will be asked to on the Zeno Walkway system to evaluate gait speed and spatiotemporal gait parameters during overground walking trials. During the testing process, participants will be recorded on video.
- Conditions
- Stroke, Healthy Volunteers
- Being tested
- Morning Walk training for stroke, Morning Walk training for healthy
- Keywords
- End-Effector Robot-Morning Walk, Constrained Induced Movement Therapy, Hemiparesis, Symmetry
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning Walk training for strokeBehavioural
Assessing the Feasibility of the End-Effector Rehabilitation Robot, Morning Walk Training and investigate the Immediate Post-Adaptation Effect of Morning Walk Training for Symmetrical Walking on the Ground.
Morning Walk training for healthyBehavioural
Assessing the Feasibility of the End-Effector Rehabilitation Robot, Morning Walk Training and investigate the Immediate Post-Adaptation Effect of Morning Walk Training for Asymmetrical Walking on the Ground.
| Study group | Role | What they receive |
|---|---|---|
| Morning Walk Training for Stroke | Experimental | Not described Receives: Behavioral: Morning Walk training for stroke |
| Morning Walk Training for Healthy | Active comparator | Not described Receives: Behavioral: Morning Walk training for healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants with Kinematic representation of the temporal events during end-effector robot training
The temporal events of foot position and foot pressure distributions will be identified from ground reaction forces (GRFs) during walking trials using the Tekscan In-shoes system (Tekscan, Inc., South Boston).
Measured: Pre-overground, Morning walk intervention, and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
Muscle Activity in the lower extremities
A wireless electromyographic sensor (Delsys Inc, Natick, MA) will be attached to the participant to analyze muscle activity in the lower extremities.
Measured: Pre-overground, Morning walk intervention, and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
Spatiotemporal Patterns of Walking, Speeds
Subjects will walk on an instrumented mat (Zeno Walkway) with the same model of New Balance shoes to measure self-selected and fastest comfortable speeds.
Measured: Pre-overground and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
Spatiotemporal Patterns of Walking, Parameters
Subjects will walk on an instrumented mat (Zeno Walkway) with the same model of New Balance shoes to measure the parameters during overground walking.
Measured: Pre-overground and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start30 May 2024
- Primary completion18 Feb 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374706
- Sponsor's protocol ID
- 23-0129
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis
- ClinicalTrials.gov ID
- NCT06374706
- Acronym / sponsor ID
- 23-0129
- Conditions
- Stroke, Healthy Volunteers
- Keywords
- End-Effector Robot-Morning Walk, Constrained Induced Movement Therapy, Hemiparesis, Symmetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards.
Detailed description
Total forty participants (20 stroke vs 20 healthy individuals) will sign a consent form that is pre-approved by the Institutional Review Board at the participating facilities, which states the purpose of the study, an explanation of the procedures, benefits and risks for the participant, a confidentiality statement, and a refusal/withdrawal policy.
This study will assess the feasibility of end-effector rehabilitation robots, specifically Morning Walk®, to optimize training outcomes and improve symmetry in individuals with stroke.
- Access the severity of functional and balance capacity prior to gait training. Stroke or healthy participants will first be asked questions about their medical history, physical functionality, and overall well-being. Participants will be equipped with an armband or chest strap to monitor their heart rate. Functional capacity will be assessed using walking tests on the Zeno Walkway system, which evaluates gait speed and spatiotemporal gait parameters during overground walking trials. During the testing process, participants will be recorded on video.
- Develop the training protocol for the end-effector rehabilitation robot, Morning Walk. Prior to the end-effector robot training, Investigators will attach six Delsys wireless electromyographic sensors (Delsys Inc, Natick, MA) to analyze muscle activity in the lower extremities. Additionally, stroke or healthy participants will be equipped with the Tekscan In-Shoes system (Tekscan, Inc., South Boston) to assess temporal events related to foot positioning during training, such as limb loading time. During the end-effector robot training, a saddle-type weight support and secure strap system will be employed to prevent loss of balance or falls. Following an appropriate warm-up and familiarization with the end-effector robot training, various walking parameters of Morning Walk, such as pace, stride length, step height, and initial contact angle, will be examined to achieve balanced loading times between the paretic and non-paretic sides in stroke participants. Training parameters such as step length, step height, and joint angle can be independently adjusted for the paretic and non-paretic sides in stroke patients, and for the dominant and non-dominant sides in healthy individuals. This approach allows for the restriction of movement in the non-paretic or non-dominant side, thereby encouraging the activity of the paretic or dominant side during training. The adaptation training parameters will be adjusted according to the participant's walking capacity. During the training session, participants will be recorded on video.
- Assessing the Immediate Post-Adaptation Effect of Morning Walk Training on the Ground.
Stroke or healthy participants will be asked to on the Zeno Walkway system to evaluate gait speed and spatiotemporal gait parameters during overground walking trials. During the testing process, participants will be recorded on video.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Walk Training for Stroke | Experimental | Behavioral: Morning Walk training for stroke |
| Morning Walk Training for Healthy | Active comparator | Behavioral: Morning Walk training for healthy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For this study, twenty volunteers fulfilling the inclusion criteria from participating physical therapy facilities and the local community will be recruited. The criteria for participants with a history of stroke include: Age 20 or older.
- Experienced a unilateral first stroke, either ischemic or hemorrhagic, in the carotid artery distribution.
- Diagnosed with stroke at least one month prior to participating in the study.
- Free from major post-stroke complications, such as recurrent stroke, hip fracture, or myocardial infarction.
- Residing within the community.
Key exclusion criteria (15 listed)
- Stroke secondary to subarachnoid hemorrhage or posterior circulation stroke.
- Life expectancy of less than one year.
- Comatose state.
- Inability to follow 3-step commands.
- Amputation.
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 |
|---|---|---|
| Morning Walk training for strokeAssessing the Feasibility of the End-Effector Rehabilitation Robot, Morning Walk Training and investigate the Immediate Post-Adaptation Effect of Morning Walk Training for Symmetrical Walking on the Ground. | Behavioural | Morning Walk Training for Stroke |
| Morning Walk training for healthyAssessing the Feasibility of the End-Effector Rehabilitation Robot, Morning Walk Training and investigate the Immediate Post-Adaptation Effect of Morning Walk Training for Asymmetrical Walking on the Ground. | Behavioural | Morning Walk Training for Healthy |
Primary outcome
The Number of Participants with Kinematic representation of the temporal events during end-effector robot training
Time frame: Pre-overground, Morning walk intervention, and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
The temporal events of foot position and foot pressure distributions will be identified from ground reaction forces (GRFs) during walking trials using the Tekscan In-shoes system (Tekscan, Inc., South Boston).
Muscle Activity in the lower extremities
Time frame: Pre-overground, Morning walk intervention, and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
A wireless electromyographic sensor (Delsys Inc, Natick, MA) will be attached to the participant to analyze muscle activity in the lower extremities.
Spatiotemporal Patterns of Walking, Speeds
Time frame: Pre-overground and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
Subjects will walk on an instrumented mat (Zeno Walkway) with the same model of New Balance shoes to measure self-selected and fastest comfortable speeds.
Spatiotemporal Patterns of Walking, Parameters
Time frame: Pre-overground and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
Subjects will walk on an instrumented mat (Zeno Walkway) with the same model of New Balance shoes to measure the parameters during overground walking.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Walk training for stroke and Morning Walk training for healthy in people with Stroke and Healthy Volunteers, run by The University of Texas Medical Branch, Galveston 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 6 inclusion and 15 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 10 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Number of Participants with Kinematic representation of the temporal events during end-effector robot training (time frame: Pre-overground, Morning walk intervention, and post-overground of assessment in one day and will be recorded continuously for 20-30minutes). The study lists 4 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 10 Apr 2025.