Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI
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|ClinicalTrials.gov Identifier: NCT03604367|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke Motor Activity||Device: GAITRite assessment||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The investigators will enroll healthy volunteers to determine that with active bipedal movement there will be no difference in head movement, but greater motor cortex BOLD signal, smoother force exchange between the feet, higher participant satisfaction than unipedal movement or motor imagery alone.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: 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.
Device: GAITRite assessment
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.
Other Name: fMRI Bipedal Paradigm
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604367
|Contact: Colleen A Hanlon, PhD||(843) email@example.com|
|Contact: Daniel H Lench, BS||(843) firstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Colleen A Hanlon, PhD 843-792-5732 email@example.com|
|Principal Investigator:||Colleen A Hanlon, PhD||Medical University of South Carolina|