StrokeNCT03604367
Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI
An observational study of Stroke and Motor Activity, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Less than 50% of stroke survivors progress to independent community ambulation. Even among the stroke survivors who achieve independent ambulation, significant residual deficits persist in balance and gait speed, with 60% of persons post-stroke reporting limitations in mobility related to walking.Consequently… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Motor Activity
- What is being tested?
- GAITRite assessment
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 14 Jun 2019
- Phase
- Observational
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers will be screened for eligibility who are right hand dominant.
Who may be able to join
- Age 21-65
- Right hand dominant
- Able to read and understand questionnaires and informed consent
Who cannot join
- Self reported history of cardiac disease, COPD or oxygen dependence, neurological and psychiatric disorders, dementia or previous stroke, major head trauma, severe visual impairment, osteoarthritis, orthopedic problems that limit passive range of motion, illegal drug or alcohol dependence, claustrophobia
- Non-mri compatible metal implants in the body
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Less than 50% of stroke survivors progress to independent community ambulation. Even among the stroke survivors who achieve independent ambulation, significant residual deficits persist in balance and gait speed, with 60% of persons post-stroke reporting limitations in mobility related to walking.Consequently maximizing recovery of locomotor function is the focus of neurorehabilitation efforts worldwide. A recently completed clinical trial from members of this investigative team demonstrated that 6 weeks of treadmill training elicits substantial improvements in over ground walking speed and symmetry in persons following stroke. Consistent with the goals of the South Carolina Stroke Rehabilitation Research Center (SCSRRC) and NIH Brain Initiative, the investigators now plan to investigate the effects treadmill-assisted gait training have on cortical control of bipedal movement in chronic stroke patients. Although previous investigators have assessed neural activity during simulated walking using motor imagery, motor imagery does not simulate the typical sensory feedback associated with active movement. To move the field forward, it is necessary to measure active bipedal movement in the MR-environment in healthy volunteers, before moving forward in stroke patients.
Read the detailed description
The overarching goal of this Discovery Proposal is to evaluate neural activity during unipedal and bipedal movement in a cohort of healthy individuals (Aim 1).
The rigor and reproducibility will be evaluated by comparing the results of 1) active movement -Bipedal with 2) active movement -unipedal 4 and 3) imagined movement.
Dependent measures include: 1) head motion during the fMRI task, 2) BOLD signal in the ipsilateral and contralateral motor cortex during the fMRI task, 3) force applied during the fMRI task, and 4) participant feedback using a modified version of the Presence Questionnaire (a standard tool to assess ecological validity of virtual environments.
Each Aim has a development and evaluation aspect. Through this 1 year proposal the investigators will determine if the bipedal fMRI protocol (active movement) is able to engage neural networks more robustly (e.g. greater effect size) than bipedal imagery alone in Healthy Volunteers.
Specific Aim #1: Healthy volunteers: The investigators will test the hypothesis that with active bipedal movement there will be 1) no difference in head movement, but 2) greater motor cortex BOLD signal, 3) smoother force exchange between the feet, 4) higher participant satisfaction than unipedal movement or motor imagery alone. This sample size was selected based on a prior publication of imagined movement. The outcome of this aim may result in the first publication in the field to evaluate bipedal movement in an MR-environment.
- Conditions
- Stroke, Motor Activity
- Being tested
- GAITRite assessment
- Keywords
- fMRI, BOLD Signal, Rehabilitation
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAITRite assessmentDevice
Also called fMRI Bipedal Paradigm
The fMRI Bipedal Paradigm will allow investigators to study the effects treadmill-assisted gait training have on cortical control of bipedal movement in chronic stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| GAITRite assessment | Subjects will undergo the GAITRite assessment of functional walking and then complete the Functional MRI Bipedal paradigm followed by questionnaires and assessments regarding the virtual environment. Receives: Device: GAITRite assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI protocols will measure neural function activity during active bipedal movement in healthy volunteers
Determine if the bipedal fMRI protocol (active movement) is able to engage neural networks more robustly (e.g. greater effect size) than bipedal imagery alone in healthy volunteers.
Measured: Duration of the study, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Feb 2018
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- MUSC Center for Biomedical Research Excellence (COBRE) in Stroke Recovery
- Responsible party
- Sponsor
- Investigators
- Colleen A Hanlon, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604367
- Sponsor's protocol ID
- 72777
- Status last verified
- Sep 2024
- First submitted
- 28 Jun 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data from the primary outcome measurement will be shared via manuscripts and after study completion by request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI
- ClinicalTrials.gov ID
- NCT03604367
- Acronym / sponsor ID
- 72777
- Conditions
- Stroke, Motor Activity
- Keywords
- fMRI, BOLD Signal, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- MUSC Center for Biomedical Research Excellence (COBRE) in Stroke Recovery
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 27 Jul 2018 (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.
Less than 50% of stroke survivors progress to independent community ambulation. Even among the stroke survivors who achieve independent ambulation, significant residual deficits persist in balance and gait speed, with 60% of persons post-stroke reporting limitations in mobility related to walking.Consequently maximizing recovery of locomotor function is the focus of neurorehabilitation efforts worldwide. A recently completed clinical trial from members of this investigative team demonstrated that 6 weeks of treadmill training elicits substantial improvements in over ground walking speed and symmetry in persons following stroke. Consistent with the goals of the South Carolina Stroke Rehabilitation Research Center (SCSRRC) and NIH Brain Initiative, the investigators now plan to investigate the effects treadmill-assisted gait training have on cortical control of bipedal movement in chronic stroke patients. Although previous investigators have assessed neural activity during simulated walking using motor imagery, motor imagery does not simulate the typical sensory feedback associated with active movement. To move the field forward, it is necessary to measure active bipedal movement in the MR-environment in healthy volunteers, before moving forward in stroke patients.
Detailed description
The overarching goal of this Discovery Proposal is to evaluate neural activity during unipedal and bipedal movement in a cohort of healthy individuals (Aim 1).
The rigor and reproducibility will be evaluated by comparing the results of 1) active movement -Bipedal with 2) active movement -unipedal 4 and 3) imagined movement.
Dependent measures include: 1) head motion during the fMRI task, 2) BOLD signal in the ipsilateral and contralateral motor cortex during the fMRI task, 3) force applied during the fMRI task, and 4) participant feedback using a modified version of the Presence Questionnaire (a standard tool to assess ecological validity of virtual environments.
Each Aim has a development and evaluation aspect. Through this 1 year proposal the investigators will determine if the bipedal fMRI protocol (active movement) is able to engage neural networks more robustly (e.g. greater effect size) than bipedal imagery alone in Healthy Volunteers.
Specific Aim #1: Healthy volunteers: The investigators will test the hypothesis that with active bipedal movement there will be 1) no difference in head movement, but 2) greater motor cortex BOLD signal, 3) smoother force exchange between the feet, 4) higher participant satisfaction than unipedal movement or motor imagery alone. This sample size was selected based on a prior publication of imagined movement. The outcome of this aim may result in the first publication in the field to evaluate bipedal movement in an MR-environment.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GAITRite assessment | – | Device: GAITRite assessmentSubjects will undergo the GAITRite assessment of functional walking and then complete the Functional MRI Bipedal paradigm followed by questionnaires and assessments regarding the virtual environment. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers will be screened for eligibility who are right hand dominant.
Key inclusion criteria (3 listed)
- Age 21-65
- Right hand dominant
- Able to read and understand questionnaires and informed consent
Key exclusion criteria (3 listed)
- Self reported history of cardiac disease, COPD or oxygen dependence, neurological and psychiatric disorders, dementia or previous stroke, major head trauma, severe visual impairment, osteoarthritis, orthopedic problems that limit passive range of motion, illegal drug or alcohol dependence, claustrophobia
- Non-mri compatible metal implants in the body
- Pregnant females
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 |
|---|---|---|
| GAITRite assessmentAlso: fMRI Bipedal ParadigmThe fMRI Bipedal Paradigm will allow investigators to study the effects treadmill-assisted gait training have on cortical control of bipedal movement in chronic stroke patients. | Device | GAITRite assessment |
Primary outcome
fMRI protocols will measure neural function activity during active bipedal movement in healthy volunteers
Time frame: Duration of the study, approximately 1 year
Determine if the bipedal fMRI protocol (active movement) is able to engage neural networks more robustly (e.g. greater effect size) than bipedal imagery alone in healthy volunteers.
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 19 Sep 2024.
- Individual participant dataSharing planned: Yes. The data from the primary outcome measurement will be shared via manuscripts and after study completion by request to the Principal Investigator.
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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.
Colleen A Hanlon, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Motor Activity, run by Medical University of South Carolina 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 3 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 19 Sep 2024. 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?
fMRI protocols will measure neural function activity during active bipedal movement in healthy volunteers (time frame: Duration of the study, approximately 1 year). 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 19 Sep 2024.