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Innovative Gait Biofeedback Strategies for Stroke Rehabilitation

Primary Purpose

Stroke, Cardiovascular, Gait, Hemiplegic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
biofeedback
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke, Cardiovascular focused on measuring gait biofeedback, gait rehabilitation, paretic propulsion, gait motor learning

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Emory Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

biofeedback 1

biofeedback 2

Arm Description

biofeedback training with progression of targets

biofeedback training with progression of targets and speeds

Outcomes

Primary Outcome Measures

paretic pushoff (AGRF)
peak GRF generated by the leg affected by the stroke

Secondary Outcome Measures

non-paretic peak AGRF
peak GRF generated by the leg not affected by the stroke
paretic trailing limb angle
angle measuring limb orientation with respect to vertical at terminal stance

Full Information

First Posted
March 1, 2018
Last Updated
May 11, 2019
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03466372
Brief Title
Innovative Gait Biofeedback Strategies for Stroke Rehabilitation
Official Title
Innovative Biofeedback Strategies for Gait Training
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
October 3, 2018 (Actual)
Study Completion Date
October 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular, Gait, Hemiplegic
Keywords
gait biofeedback, gait rehabilitation, paretic propulsion, gait motor learning

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
biofeedback 1
Arm Type
Experimental
Arm Description
biofeedback training with progression of targets
Arm Title
biofeedback 2
Arm Type
Active Comparator
Arm Description
biofeedback training with progression of targets and speeds
Intervention Type
Behavioral
Intervention Name(s)
biofeedback
Intervention Description
treadmill walking with biofeedback regarding propulsion and other gait parameters
Primary Outcome Measure Information:
Title
paretic pushoff (AGRF)
Description
peak GRF generated by the leg affected by the stroke
Time Frame
Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
Secondary Outcome Measure Information:
Title
non-paretic peak AGRF
Description
peak GRF generated by the leg not affected by the stroke
Time Frame
Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
Title
paretic trailing limb angle
Description
angle measuring limb orientation with respect to vertical at terminal stance
Time Frame
Immediately after the 6-minute biofeedback training bout (Post-0 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trisha Kesar
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Univeristy
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29457532
Citation
Genthe K, Schenck C, Eicholtz S, Zajac-Cox L, Wolf S, Kesar TM. Effects of real-time gait biofeedback on paretic propulsion and gait biomechanics in individuals post-stroke. Top Stroke Rehabil. 2018 Apr;25(3):186-193. doi: 10.1080/10749357.2018.1436384. Epub 2018 Feb 19.
Results Reference
background
PubMed Identifier
28583196
Citation
Schenck C, Kesar TM. Effects of unilateral real-time biofeedback on propulsive forces during gait. J Neuroeng Rehabil. 2017 Jun 6;14(1):52. doi: 10.1186/s12984-017-0252-z.
Results Reference
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Innovative Gait Biofeedback Strategies for Stroke Rehabilitation

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