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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • 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

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
Intervention / Treatment
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

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

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

Emory University

Investigators

  • 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)

March 22, 2018

Primary Completion (Actual)

October 3, 2018

Study Completion (Actual)

October 3, 2018

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 11, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Gait, Hemiplegic

Clinical Trials on biofeedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe