StrokeNCT06008743
Model-informed Patient-specific Rehabilitation Using Robotics and Neuromuscular Modeling
A study testing Belt Accelerations, Belt accelerations combined with an exoskeleton and Variable Stiffness treadmill in people with Stroke, run by University of Delaware at 1 site in United States.
Trial summary
Stroke is the third leading cause of death and the primary cause of long-term disability in the United States, affecting approximately 795,000 people each year. Hemiparesis, or unilateral weakness, is common after stroke and responsible for changes in muscle activation and movement patterns as well as declines in… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Belt Accelerations, Belt accelerations combined with an exoskeleton and Variable Stiffness treadmill
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 30 Jun 2026
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Two groups of subjects will be included in the study.
- Group A: Individuals must be between the ages of 18 and 80 years, be in general good health, and be proficient in English. The subjects' physical fitness for participation in the research procedures will be documented via the Physical Readiness Questionnaire (PAR-Q). Their answers to the PAR-Q will be evaluated by the study team to determine if they are suitable for the study. Individuals should not have significant musculoskeletal conditions (osteoarthritis, joint replacement etc). The subjects' resting heart rate must be between 60-100 beats per minute, while their resting blood pressure between 90/60 to 140/90. The subjects should weigh under 250 pounds (lbs).
- Group B: Individuals must be between the ages of 18 and 80 years, speak English, have a single, unilateral, chronic stroke (>6 months post-stroke), confirmed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan. They should be able to walk at a self-selected speed for at least 15 minutes without assistance from another person. They should be able to respond to questions during screening, provide informed consent and fully follow instructions. The subjects' resting heart rate must be between 60-100 beats per minute, while their resting blood pressure between 90/60 to 160/90. The subjects should weigh under 250 pounds (lbs).
Who cannot join
- Any neurological conditions (applicable to Group A - healthy subjects) or other neurological conditions in addition to stroke (applicable to Group B - stroke survivors);
- Inability to walk outside the home before the stroke (applicable to Group B - stroke survivors);
- Coronary artery bypass graft in the past 3 months, myocardial infarction in the past 3 months, uncontrolled or untreated atrial fibrillation, severe or painful peripheral vascular disease, diagnosis of heart failure, or unstable or untreated angina;
- Expressive aphasia
- Reported musculoskeletal pain or conditions that limit walking (such as tendonitis, arthritis, osteoporosis, spinal stenosis, or any orthopedic surgery or fracture to the legs or spine in the last 6 months);
- Inability to communicate with investigators (e.g., due to severe aphasia or other cognitive impairment);
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- Severe respiratory problems such as chronic obstructive pulmonary disease (COPD);
- Unexplained dizziness;
- Weight greater than 250 pounds (lbs).
- Inability to ascend and descend 4 steps with handrails using another person's assistance (if desired)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Delaware
Newark, Delaware, 19716
Panagiotis Artemiadis, Ph.D., 302-831-8546, partem@udel.edu
Panagiotis Artemiadis, Ph.D.
About this study
Stroke is the third leading cause of death and the primary cause of long-term disability in the United States, affecting approximately 795,000 people each year. Hemiparesis, or unilateral weakness, is common after stroke and responsible for changes in muscle activation and movement patterns as well as declines in walking speed. It has been shown that increased walking speed directly corresponds to a higher quality of life in older adults and therefore, is often the goal of motor rehabilitation after stroke. However, there is no consensus on the best method for improving walking function after stroke and the results of post-stroke gait studies vary widely across sites and studies. Walking is one of the human's most important functions that serve survival, progress, and interaction. The force between the foot and the walking surface is very important. Although there have been many studies trying to understand this, there is a need for the development of a system that can advance research and provide new functionality. In this work, we will conduct a series of studies that attempt to analyze human gait and adaptations from different perspectives.
- Conditions
- Stroke
- Being tested
- Belt Accelerations, Belt accelerations combined with an exoskeleton, Variable Stiffness treadmill
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belt AccelerationsBehavioural
Intervention used in both healthy and stroke survivors. In this mode, participants are walking on a treadmill with two belts with independent speed control. The speed of each belt will increase with constant acceleration during double support, shortly before push-off of the supported leg.
Belt accelerations combined with an exoskeletonBehavioural
Intervention used in both healthy and stroke survivors. In this mode, participants are walking on a treadmill with two belts with independent speed control, and using a hip exoskeleton. The velocity of each belt will increase with constant acceleration during double support, shortly before push-off of the supported leg. At the same time, they will be interacting with a wearable motion assistive device (i.e., exoskeleton). The exoskeleton will apply forces to the leg to resist hip extension during accelerations, reducing hip extension relative to the values of that participant at baseline.
Variable Stiffness treadmillBehavioural
Intervention used in both healthy and stroke survivors. In this mode, participants are walking on a treadmill with two belts with identical speed control. A variable stiffness mechanism under one belt will change the vertical stiffness of one side of the treadmill for one or multiple steps. The walkers will be informed before stepping on the softer surface on one side, which can be either the left or the right side.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects (healthy and stroke survivors) participating in the study Receives: Behavioral: Belt Accelerations; Behavioral: Belt accelerations combined with an exoskeleton; Behavioral: Variable Stiffness treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contralateral plantarflexor muscle activation during exposure to belt accelerations
Magnitude of the neural signal (in millivolts (mV) sent to three muscles during push-off, as explained via surface ElectroMyoGraphic signals, measured during exposure to belt accelerations. Three measurements (one from each relevant muscle) will be considered primary outcome measures.
Measured: During intervention
Contralateral plantarflexor muscle activation during exposure to combined exposure to belt accelerations and exoskeleton interaction
Magnitude of the neural signal (in millivolts (mV) sent to three muscles during push-off, as explained via surface ElectroMyoGraphic signals, measured during exposure to combined exposure to belt accelerations and exoskeleton interaction. Three measurements (one from each relevant muscle) will be considered primary outcome measures.
Measured: During intervention
Contralateral plantarflexor muscle activation during exposure to lowered stiffness step perturbation
Magnitude of the neural signal (in millivolts (mV) sent to three muscles during push-off, as explained via surface ElectroMyoGraphic signals, measured during exposure to lowered stiffness step perturbation. Three measurements (one from each relevant muscle) will be considered primary outcome measures.
Measured: During intervention
Hip extension exposure to belt accelerations
Extension of the leg during push-off, measured as hip extension angle in degrees, during exposure to belt accelerations.
Measured: During intervention
Hip extension during exposure to combined exposure to belt accelerations and exoskeleton interaction
Extension of the leg during push-off, measured as hip extension angle in degrees, during exposure to combined exposure to belt accelerations and exoskeleton interaction.
Measured: During intervention
Hip extension during exposure to lowered stiffness step perturbation
Extension of the leg during push-off, measured as hip extension angle in degrees, during exposure to lowered stiffness step perturbation.
Measured: During intervention
Step length symmetry exposure to belt accelerations
Step length symmetry, measured as a percentage of the left leg step length to the right leg step length, during exposure to belt accelerations.
Measured: During intervention
Step length symmetry during exposure to combined exposure to belt accelerations and exoskeleton interaction
Step length symmetry, measured as a percentage of the left leg step length to the right leg step length, during exposure to combined exposure to belt accelerations and exoskeleton interaction.
Measured: During intervention
Step length symmetry during exposure to lowered stiffness step perturbation
Step length symmetry, measured as a percentage of the left leg step length to the right leg step length, during exposure to lowered stiffness step perturbation.
Measured: During intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start21 Sep 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008743
- Sponsor's protocol ID
- R01HD111071
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared for confidentiality reasons, as approved by the Institutional Review Board (IRB) of the university.
Publications
Chambers V, Artemiadis P. Using robot-assisted stiffness perturbations to evoke aftereffects useful to post-stroke gait rehabilitation. Front Robot AI. 2023 Jan 4;9:1073746. doi: 10.3389/frobt.2022.1073746. eCollection 2022.
PubMed 36686210
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-informed Patient-specific Rehabilitation Using Robotics and Neuromuscular Modeling
- ClinicalTrials.gov ID
- NCT06008743
- Acronym / sponsor ID
- R01HD111071
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Aug 2023 (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.
Stroke is the third leading cause of death and the primary cause of long-term disability in the United States, affecting approximately 795,000 people each year. Hemiparesis, or unilateral weakness, is common after stroke and responsible for changes in muscle activation and movement patterns as well as declines in walking speed. It has been shown that increased walking speed directly corresponds to a higher quality of life in older adults and therefore, is often the goal of motor rehabilitation after stroke. However, there is no consensus on the best method for improving walking function after stroke and the results of post-stroke gait studies vary widely across sites and studies. Walking is one of the human's most important functions that serve survival, progress, and interaction. The force between the foot and the walking surface is very important. Although there have been many studies trying to understand this, there is a need for the development of a system that can advance research and provide new functionality. In this work, we will conduct a series of studies that attempt to analyze human gait and adaptations from different perspectives.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Behavioral: Belt Accelerations, Behavioral: Belt accelerations combined with an exoskeleton, Behavioral: Variable Stiffness treadmillAll subjects (healthy and stroke survivors) participating in the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Two groups of subjects will be included in the study.
- Group A: Individuals must be between the ages of 18 and 80 years, be in general good health, and be proficient in English. The subjects' physical fitness for participation in the research procedures will be documented via the Physical Readiness Questionnaire (PAR-Q). Their answers to the PAR-Q will be evaluated by the study team to determine if they are suitable for the study. Individuals should not have significant musculoskeletal conditions (osteoarthritis, joint replacement etc). The subjects' resting heart rate must be between 60-100 beats per minute, while their resting blood pressure between 90/60 to 140/90. The subjects should weigh under 250 pounds (lbs).
- Group B: Individuals must be between the ages of 18 and 80 years, speak English, have a single, unilateral, chronic stroke (>6 months post-stroke), confirmed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan. They should be able to walk at a self-selected speed for at least 15 minutes without assistance from another person. They should be able to respond to questions during screening, provide informed consent and fully follow instructions. The subjects' resting heart rate must be between 60-100 beats per minute, while their resting blood pressure between 90/60 to 160/90. The subjects should weigh under 250 pounds (lbs).
Key exclusion criteria (10 listed)
- Any neurological conditions (applicable to Group A - healthy subjects) or other neurological conditions in addition to stroke (applicable to Group B - stroke survivors);
- Inability to walk outside the home before the stroke (applicable to Group B - stroke survivors);
- Coronary artery bypass graft in the past 3 months, myocardial infarction in the past 3 months, uncontrolled or untreated atrial fibrillation, severe or painful peripheral vascular disease, diagnosis of heart failure, or unstable or untreated angina;
- Expressive aphasia
- Reported musculoskeletal pain or conditions that limit walking (such as tendonitis, arthritis, osteoporosis, spinal stenosis, or any orthopedic surgery or fracture to the legs or spine in the last 6 months);
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 |
|---|---|---|
| Belt AccelerationsIntervention used in both healthy and stroke survivors. In this mode, participants are walking on a treadmill with two belts with independent speed control. The speed of each belt will increase with constant acceleration during double support, shortly before push-off of the supported leg. | Behavioural | All subjects |
| Belt accelerations combined with an exoskeletonIntervention used in both healthy and stroke survivors. In this mode, participants are walking on a treadmill with two belts with independent speed control, and using a hip exoskeleton. The velocity of each belt will increase with constant acceleration during double support, shortly before push-off of the supported leg. At the same time, they will be interacting with a wearable motion assistive device (i.e., exoskeleton). The exoskeleton will apply forces to the leg to resist hip extension during accelerations, reducing hip extension relative to the values of that participant at baseline. | Behavioural | All subjects |
| Variable Stiffness treadmillIntervention used in both healthy and stroke survivors. In this mode, participants are walking on a treadmill with two belts with identical speed control. A variable stiffness mechanism under one belt will change the vertical stiffness of one side of the treadmill for one or multiple steps. The walkers will be informed before stepping on the softer surface on one side, which can be either the left or the right side. | Behavioural | All subjects |
Primary outcome
Contralateral plantarflexor muscle activation during exposure to belt accelerations
Time frame: During intervention
Magnitude of the neural signal (in millivolts (mV) sent to three muscles during push-off, as explained via surface ElectroMyoGraphic signals, measured during exposure to belt accelerations. Three measurements (one from each relevant muscle) will be considered primary outcome measures.
Contralateral plantarflexor muscle activation during exposure to combined exposure to belt accelerations and exoskeleton interaction
Time frame: During intervention
Magnitude of the neural signal (in millivolts (mV) sent to three muscles during push-off, as explained via surface ElectroMyoGraphic signals, measured during exposure to combined exposure to belt accelerations and exoskeleton interaction. Three measurements (one from each relevant muscle) will be considered primary outcome measures.
Contralateral plantarflexor muscle activation during exposure to lowered stiffness step perturbation
Time frame: During intervention
Magnitude of the neural signal (in millivolts (mV) sent to three muscles during push-off, as explained via surface ElectroMyoGraphic signals, measured during exposure to lowered stiffness step perturbation. Three measurements (one from each relevant muscle) will be considered primary outcome measures.
Hip extension exposure to belt accelerations
Time frame: During intervention
Extension of the leg during push-off, measured as hip extension angle in degrees, during exposure to belt accelerations.
Hip extension during exposure to combined exposure to belt accelerations and exoskeleton interaction
Time frame: During intervention
Extension of the leg during push-off, measured as hip extension angle in degrees, during exposure to combined exposure to belt accelerations and exoskeleton interaction.
Hip extension during exposure to lowered stiffness step perturbation
Time frame: During intervention
Extension of the leg during push-off, measured as hip extension angle in degrees, during exposure to lowered stiffness step perturbation.
Step length symmetry exposure to belt accelerations
Time frame: During intervention
Step length symmetry, measured as a percentage of the left leg step length to the right leg step length, during exposure to belt accelerations.
Step length symmetry during exposure to combined exposure to belt accelerations and exoskeleton interaction
Time frame: During intervention
Step length symmetry, measured as a percentage of the left leg step length to the right leg step length, during exposure to combined exposure to belt accelerations and exoskeleton interaction.
Step length symmetry during exposure to lowered stiffness step perturbation
Time frame: During intervention
Step length symmetry, measured as a percentage of the left leg step length to the right leg step length, during exposure to lowered stiffness step perturbation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Background: PubMed 36686210Chambers V, Artemiadis P. Using robot-assisted stiffness perturbations to evoke aftereffects useful to post-stroke gait rehabilitation. Front Robot AI. 2023 Jan 4;9:1073746. doi: 10.3389/frobt.2022.1073746. eCollection 2022.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared for confidentiality reasons, as approved by the Institutional Review Board (IRB) of the university.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belt Accelerations, Belt accelerations combined with an exoskeleton and Variable Stiffness treadmill in people with Stroke, run by University of Delaware 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contralateral plantarflexor muscle activation during exposure to belt accelerations (time frame: During intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06008743, which also lists 1 linked publication.
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 24 Aug 2023.