Motor Skill Acquisition Between Individuals With Neurological Disorders and Healthy Individuals

August 3, 2020 updated by: Shih-Chiao Tseng, Texas Woman's University

Comparison of Motor Skill Acquisition Between Individuals With Neurological Disorders

Stroke survivors frequently show persistent gait deficits in their chronic stages even after years of intensive rehabilitation. This may be caused by diminished capability of re-acquiring motor skills post stroke. Thus, the overall purpose of this research project is to examine stroke survivors' capability of learning a novel leg task over 3 visits, 1-2 weeks apart. The capability of learning a new skill is then correlated with the individual's neurological functions (nerve activity and movement coordination) and her/his gait performance (gait speed, gait symmetry, and force production).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The walking after stroke called "hemiparetic gait" is characterized by slow and asymmetrical steps with poor motor control on the paretic leg while paradoxically increasing the cost of energy expenditure. Biomechanical evidence shows that impaired gait performance for people with chronic stroke is not solely the result of the loss of muscle strength, but involves complicated movement discoordination across multiple joints in the affected leg. This has been taken to indicate a persistent motor control deficit in the paretic leg post stroke. Recent imaging studies suggest that the persistent motor control deficit after stroke may be the result of the disruption of motor memory consolidation, a process by which a newly-learned motor skill is transformed from a fragile state to a stable state and is "saved" in our brain afterward. This indicates that the same brain area responsible for controlling motor activity is also involved in memorizing newly-learned skills during the early stage of motor learning. Presence of persistent motor control deficits in the chronic stage may be attributed to the fact that damage to the brain cortex significantly impacts the ability of acquiring motor skills and consequentially defers the improvement of motor function, including gait.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Shih-Chiao Tseng, PT, PhD
  • Phone Number: 713-794-2309
  • Email: stseng@twu.edu

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Woman's University
        • Contact:
          • Shih-Chiao Tseng, PT, PhD
          • Phone Number: 703-794-2309
          • Email: stseng@twu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Three cohorts, including individuals with chronic stroke and multiple sclerosis, and healthy adults.will be recruited via research flyers from communities around Great Houston areas in Texas.

Description

Inclusion Criteria:

  • Healthy adults have no ongoing neurological, musculoskeletal issues.
  • Individuals with chronic stroke had medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment.
  • Individuals have multiple sclerosis disease diagnosed by his/her physician
  • MRI or CT evidence from the imaging report shown that the stroke and multiple sclerosis disease primarily involve cortical and subcortical regions.
  • Individuals with chronic stroke have hemiparesis involving the lower extremity.
  • Individuals with chronic stroke or multiple sclerosis have no passive range of motion limitation in bilateral hips and knees. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less.
  • Visual acuity can be corrected by glasses or contact lens to 20/20.
  • Able to walk independently with/without assistant devices for 10 meters.
  • Able to maintain standing position without any assistance for more than 30 sec.
  • Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24.

Exclusion Criteria:

  • Pregnant women.
  • MRI or CT evidence of involvement of the basal ganglia or cerebellum, or evidence of any other brain damage or malignant neoplasm or tumors.
  • Have any metal implants, cardiac pacemakers, or history of seizures.
  • Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training.
  • Any vestibular dysfunction or unstable angina.
  • Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia*

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Chronic Stroke
Participants who suffered a single event of cerebral vascular accident at least six months ago before study enrollment.
Behavioral: Visuomotor leg reaching task
Similar to a hand reaching task in which participants were asked to reach to a tea-cup, in a visuomotor leg reaching task, participants will be seated and given real-time visual feedback about their leg movements via a cursor display on a computer screen. The task is to control a foot mouse/marker attached to the foot and move the cursor from a start location to the target displayed on a wall screen. Three different targets, equidistant from the start location at top, top-left, and top-right screen positions, will be used for leg reaching. In each trial, one of three targets will be randomly presented and subjects will be instructed to make forward, or rightward, or leftward foot reaches to guide the cursor to one of the targets. Throughout the entire experiment, subjects are blocked from viewing leg movements by a cardboard.
Other Names:
  • Leg reaching task
Multiple Sclerosis
Participants who has been diagnosed with multiple sclerosis
Behavioral: Visuomotor leg reaching task
Similar to a hand reaching task in which participants were asked to reach to a tea-cup, in a visuomotor leg reaching task, participants will be seated and given real-time visual feedback about their leg movements via a cursor display on a computer screen. The task is to control a foot mouse/marker attached to the foot and move the cursor from a start location to the target displayed on a wall screen. Three different targets, equidistant from the start location at top, top-left, and top-right screen positions, will be used for leg reaching. In each trial, one of three targets will be randomly presented and subjects will be instructed to make forward, or rightward, or leftward foot reaches to guide the cursor to one of the targets. Throughout the entire experiment, subjects are blocked from viewing leg movements by a cardboard.
Other Names:
  • Leg reaching task
Healthy control
Age-matched healthy adults who are self-reported healthy and has no known musculoskeletal, neuromuscular, and cardiovascular diseases.
Behavioral: Visuomotor leg reaching task
Similar to a hand reaching task in which participants were asked to reach to a tea-cup, in a visuomotor leg reaching task, participants will be seated and given real-time visual feedback about their leg movements via a cursor display on a computer screen. The task is to control a foot mouse/marker attached to the foot and move the cursor from a start location to the target displayed on a wall screen. Three different targets, equidistant from the start location at top, top-left, and top-right screen positions, will be used for leg reaching. In each trial, one of three targets will be randomly presented and subjects will be instructed to make forward, or rightward, or leftward foot reaches to guide the cursor to one of the targets. Throughout the entire experiment, subjects are blocked from viewing leg movements by a cardboard.
Other Names:
  • Leg reaching task

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in movement errors
Time Frame: During the first session of learning visuomotor leg reaching task, 24-hour after the first session, and 7-days after the first learning learning session
Average movement error will be calculated as the angular deviation of the foot path from a straight line path to the target at the time of peak velocity in each trial.
During the first session of learning visuomotor leg reaching task, 24-hour after the first session, and 7-days after the first learning learning session
Peripheral nerve activity
Time Frame: During the first session of learning visuomotor leg reaching task
A surface electrode will be placed on the calf muscle in one leg. Then a low-intensity of electrical stimulation will be delivered to a nerve behind the knee to trigger the motor responses.
During the first session of learning visuomotor leg reaching task

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Walking performance
Time Frame: Before the first session of learning visuomotor leg reaching task
Gait speed will be calculated during overground walking
Before the first session of learning visuomotor leg reaching task
Mini-mental State Examination
Time Frame: Before the first session of learning visuomotor leg reaching task
A standardized questionnaires to evaluate the cognitive function consisting of 11 items with a possible summed score ranging from zero to 30. The most widely accepted and frequently used cutoff score for the MMSE is 23, with scores of 23 or lower indicating the presence of cognitive impairment. A higher score means a better cognitive function.
Before the first session of learning visuomotor leg reaching task
Fugl-Meyer Lower Extremity Function Assessment
Time Frame: Before the first session of learning visuomotor leg reaching task
A standardized questionnaires to evaluate the lower extremity motor function consisting of movement, coordination, and reflex assessments at hip, knee, and ankle. Possible summed scores range from zero to 34. Higher scores indicate higher and better motor function.
Before the first session of learning visuomotor leg reaching task

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Woman's University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shih-Chiao Tseng, PT, PhD, Texas Woman's University School of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TWU Houston#17203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings