Innovative Gait Biofeedback Strategies for Stroke Rehabilitation

May 11, 2019 updated by: Trisha Kesar, PT, PhD, Emory University

Innovative Biofeedback Strategies for Gait Training

The long-term study goal is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The current project aims to address fundamental questions regarding the optimal methodology to deliver AGRF biofeedback during gait, and the feasibility and preliminary efficacy of AGRF progression protocols for improved gait patterns and gait function. The study objectives are to (1) evaluate the immediate effects of biofeedback training methodology on gait biomechanics; and (2) evaluate the feasibility and short-term effects on gait performance of a real-time biofeedback protocol incorporating progression criteria (similar to those employed during clinical rehabilitative training).

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

Even after discharge from rehabilitation, residual gait deficits are prevalent in stroke survivors, leading to decreased walking speed and endurance. Because gait dysfunctions limit community mobility, stroke survivors and rehabilitation clinicians consider restoration of walking a major goal of rehabilitation. Biomechanical impairments, such as reduced knee and ankle flexion during swing phase negatively affect gait function and increase the risk for falls. During the stance phase, decreased contribution of the paretic leg to forward propulsion during paretic terminal stance is a critical post-stroke gait deficit shown to be correlated with hemiparetic severity, walking speed, and gait asymmetry. These gait deficits can lead to falls, increased energy cost of gait, and decreased endurance. Also, a slowed self-selected walking speed is one of the hallmarks of post-stroke gait, and greatly limits community participation in individuals post-stroke. Very few interventions provide targeted practice of biomechanically appropriate movement patterns exclusively or preferentially to the paretic leg. Biofeedback can enhance an individual's awareness of the impairment targeted during gait training, enabling self-correction of aberrant gait patterns. Real-time biofeedback gait training has been used for modulating step length asymmetry in people post-stroke. A recent study developed a protocol combining treadmill training with visual and auditory real-time biofeedback to increase anterior ground reaction force (AGRF). AGRF biofeedback may be a beneficial strategy to target unilateral propulsion deficits in people post-stroke. The goal of this study is to develop improved methodologies for AGRF gait biofeedback and to evaluate the feasibility and short-term effects of gait biofeedback. To achieve this goal, experiments will be performed on young able-bodied individuals as well as stroke survivors.

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.
20

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
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Univeristy

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

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Stroke participants:

  • age 30-90 years (stroke) or 18-50 years (able-bodied controls)
  • chronic stroke (>6 months post stroke)
  • ambulatory with or without the use of a cane or walker
  • able to walk for 2 minutes at the self-selected speed without an orthoses
  • resting heart rate 40-100 beats per minute

Able-bodied participants:

  • age 18 to 50 years
  • no history of neurologic disease
  • no history of orthopedic disease or injury affecting the lower extremity.

Exclusion Criteria:

Stroke participants:

  • Cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
  • History of lower extremity joint replacement
  • Inability to communicate with investigators
  • Neglect/hemianopia, or unexplained dizziness in last 6 months
  • Neurologic conditions other than stroke
  • Orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking or cause pain during walking.

Able-bodied controls

  • History of neurologic disease
  • History of orthopedic disease or injury to the lower extremity in the past 6 months
  • Pain or discomfort during walking
  • Cardiovascular or medical condition affecting ability to exercise or walk.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: biofeedback 1
biofeedback training with progression of targets
Behavioral: biofeedback
treadmill walking with biofeedback regarding propulsion and other gait parameters
Active Comparator: biofeedback 2
biofeedback training with progression of targets and speeds
Behavioral: biofeedback
treadmill walking with biofeedback regarding propulsion and other gait parameters

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
paretic pushoff (AGRF)
Time Frame: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
peak GRF generated by the leg affected by the stroke
Immediately after the 6-minute biofeedback training bout (Post-0 minutes)

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
non-paretic peak AGRF
Time Frame: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
peak GRF generated by the leg not affected by the stroke
Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
paretic trailing limb angle
Time Frame: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
angle measuring limb orientation with respect to vertical at terminal stance
Immediately after the 6-minute biofeedback training bout (Post-0 minutes)

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.
Emory 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: Trisha Kesar, Emory University

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 (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.
March 22, 2018

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.
October 3, 2018

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.
October 3, 2018

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).
March 1, 2018

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.
March 8, 2018

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.
March 15, 2018

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.
May 14, 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.
May 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.
May 1, 2019

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.
  • IRB00102559

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.

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