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

NCT03604367 | Completed DMC

• 1 other identifier: 72777
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke; Motor Activity

Keywords

fMRI; BOLD Signal; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

GAITRite assessment DEVICE

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.

Also known as: fMRI Bipedal Paradigm

GAITRite assessment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• MUSC Center for Biomedical Research Excellence (COBRE) in Stroke Recovery: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Colleen A Hanlon, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 27, 2018
• Study Start: February 1, 2018
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available immediately after first publication of the results. This is estimated to be at the end of 2019.
• Access Criteria: Interested parties should contact the Principal Investigator directly

Locations

US (1)