Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Motor Activity
• Intervention / Treatment: Device: GAITRite assessment

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be screened for eligibility who are right hand dominant.

Description

Inclusion criteria:

• Age 21-65
• Right hand dominant
• Able to read and understand questionnaires and informed consent

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: fMRI Bipedal Paradigm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: MUSC Center for Biomedical Research Excellence (COBRE) in Stroke Recovery
• Investigators: Principal Investigator: Colleen A Hanlon, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): June 14, 2019
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; fMRI; BOLD Signal
• Other Study ID Numbers: 72777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data from the primary outcome measurement will be shared via manuscripts and after study completion by request to the Principal Investigator.
• IPD Sharing Time Frame: The data will be available immediately after first publication of the results. This is estimated to be at the end of 2019.
• IPD Sharing Access Criteria: Interested parties should contact the Principal Investigator directly
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes