NCT03604367|CompletedDMC
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Sponsor study identifier
observational
21
1 country
1
Study Start
February 1, 2018
Actual (reported)Primary Completion
June 14, 2019
Actual (reported)Study Completion
June 14, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 14, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2018
Actual (reported)June 28, 2018
Actual (reported)July 27, 2018
Actual (reported)June 14, 2019
Actual (reported)June 14, 2019
Actual (reported)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.
Duration of the study, approximately 1 year
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy volunteers will be screened for eligibility who are right hand dominant.
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Colleen A Hanlon, PhD
Medical University of South Carolina
21 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2018
First Posted
July 27, 2018
Study Start
February 1, 2018
Actual (reported)Primary Completion
Functional Connectivity & Stimulation-enhanced Therapy Post Stroke
Contact the study team to confirm eligibility.
June 14, 2019
Actual (reported)Study Completion
June 14, 2019
Actual (reported)Last Updated
September 19, 2024
Record last verified: 2024-09
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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Source: ClinicalTrials.gov.
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