Error Based Learning for Restoring Gait Symmetry Post-Stroke

February 11, 2019 updated by: University of North Carolina, Chapel Hill
Many of the 780,000 people affected by stroke each year are left with slow, asymmetric walking patterns. The proposed project will evaluate the effectiveness of two competing motor learning approaches to restore symmetric gait for faster, more efficient, and safer walking.

Study Overview

Status

Status

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

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

Walking after stroke is characterized by reduced gait speed and the presence of interlimb spatiotemporal asymmetry. These step length and stance time asymmetries can be energy inefficient, challenge balance control, increase the risk of falls and injury, and limit functional mobility. Current rehabilitation to improve gait is based on one of two competing motor learning strategies: minimizing or augmenting symmetry errors during training. Conventional rehabilitation often involves walking on a treadmill while therapists attempt to minimize symmetry errors during training. Although this approach can successfully improve gait speed, it does not produce long-term changes in symmetry. Conversely, augmenting or amplifying symmetry errors has been produced by walking on a split belt treadmill with the belts set at different fixed speeds. While this approach produced an 'after-effect' resulting in step length symmetry for short periods of time, with some evidence of long term learning in people with stroke, it had no influence on stance time asymmetry. The investigators propose that patients need real-time proprioceptive feedback of symmetry errors so that they are actively engaged in the learning process. For this project, the investigators developed and validated a novel, responsive, 'closed loop' control system, using a split-belt instrumented treadmill that continuously adjusts the difference in belt speeds to be proportional to the patient's current asymmetry. Using this system, the investigators can either augment or minimize asymmetry on a step-by-step basis to determine which motor learning strategy produces the largest improvement in overground spatiotemporal symmetry.

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.
Interventional

Enrollment (Actual)

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.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ability to walk >10 m overground without physical assistance
  • overground comfortable gait speed (CGS) < 1.0 m/s (using assistive devices and bracing below the knee as needed)
  • able to walk independently on the treadmill at >80% CGS
  • exhibits stance time and/or step length asymmetry during CGS

Exclusion Criteria:

  • cerebellar lesion
  • uncontrolled cardiorespiratory/metabolic disease (cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema)or other neurological or orthopedic disorders that may affect gait training
  • botulinum toxin to the lower limb in the past 6 months
  • a history of balance deficits or unexplained falls not related to the stroke
  • uncontrolled seizures
  • concurrent physical therapy
  • Mini-Mental Status Exam (MMSE) < 24
  • communication impairments which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Control
Symmetric Gait. Dual-belted treadmill belts moving at the same belt speeds during training
Other: Same Belt Speeds
18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax. Control-Dual-belted treadmill belts respond to encourage symmetric gait
Experimental: Gait Asymmetry
Error Augmentation. Belts of a dual-belted treadmill may move at different belt speeds to amplify spatiotemporal gait asymmetry during training
Other: Different Belt Speeds
18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax. Treadmill belts of dual-belted treadmill respond either to amplify asymmetric gait or encourage symmetric gait.
Experimental: Gait Symmetry
Error Minimization. Belts of a dual-belted treadmill may move at different belt speeds to encourage spatiotemporal gait symmetry during training
Other: Different Belt Speeds
18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax. Treadmill belts of dual-belted treadmill respond either to amplify asymmetric gait or encourage symmetric gait.

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
Change from baseline in spatiotemporal gait symmetry after 6 weeks of training
Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks
Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.
participants will be followed for the duration of their training, expected to be about 6 weeks

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
Change from baseline in gait speed after 6 weeks of training
Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks
Gait speed is measured in m/sec by having participants walk across a 14' pressure sensitive mat.
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in balance after 6 weeks of training
Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks
Balance will be assessed using the Berg Balance Scale, 4square step test, and the Functional Gait Assessment
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in endurance after 6 weeks of training
Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks
Endurance will be measured as the distance walked (in meters) during the 6 Minute Walk Test
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in quality of life after 6 weeks of training
Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks
Quality of Life will be assessed using the Stroke Impact Scale
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in metabolic efficiency after 6 weeks of training
Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks
Metabolic efficiency is measured as the metabolic cost of transport (MCOT) using a portable metabolic cart to assess cardiorespiratory gas exchange during the 6 Minute Walk Test.
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in community ambulation after 6 weeks of training
Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks
Community ambulation is assessed using Step Watch Monitors (SAMs) which will be worn daily for a minimum of 7 days during waking hours.
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in gait speed at 1 month follow-up
Time Frame: participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Gait speed is measured in m/sec by having participants walk across a 14' pressure sensitive mat.
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Change from baseline in balance at 1 month follow up
Time Frame: participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Balance will be assessed using the Berg Balance Scale, 4square step test, and the Functional Gait Assessment
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Change from baseline in endurance at 1 month follow up
Time Frame: participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Endurance will be measured as the distance walked (in meters) during the 6 Minute Walk Test
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Change from baseline in quality of life at 1 month follow up
Time Frame: participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Quality of Life will be assessed using the Stroke Impact Scale
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Change from baseline in metabolic efficiency at 1 month follow up
Time Frame: participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Metabolic efficiency is measured as the metabolic cost of transport (MCOT) using a portable metabolic cart to assess cardiorespiratory gas exchange during the 6 Minute Walk Test.
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Change from baseline in community ambulation at 1 month follow up
Time Frame: participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Community ambulation is assessed using Step Watch Monitors (SAMs) which will be worn daily for a minimum of 7 days during waking hours.
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Change from baseline in spatiotemporal gait asymmetry at 1 month follow up
Time Frame: participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks

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.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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: Michael D Lewek, PT, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
January 1, 2012

Primary Completion (Actual)

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 1, 2015

Study Completion (Actual)

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 1, 2015

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).
May 8, 2012

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.
May 10, 2012

First Posted (Estimate)

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.
May 15, 2012

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.
February 15, 2019

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.
February 11, 2019

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.
April 1, 2016

More Information

Terms related to this study

Keywords

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.
  • 11-1240
  • R21HD068805 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Stroke

Clinical Trials on Same Belt Speeds

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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