Innovative Gait Biofeedback Strategies for Stroke Rehabilitation

NCT03466372 | Completed

• 1 other identifier: IRB00102559
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke, Cardiovascular; Gait, Hemiplegic

Keywords

gait biofeedback; gait rehabilitation; paretic propulsion; gait motor learning

Outcome Measures

Primary Outcomes (1)

• paretic pushoff (AGRF)

  peak GRF generated by the leg affected by the stroke

  Immediately after the 6-minute biofeedback training bout (Post-0 minutes)

Secondary Outcomes (2)

• non-paretic peak AGRF

  Immediately after the 6-minute biofeedback training bout (Post-0 minutes)

• paretic trailing limb angle

  Immediately after the 6-minute biofeedback training bout (Post-0 minutes)

Study Arms (2)

biofeedback 1

EXPERIMENTAL

biofeedback training with progression of targets

Behavioral: biofeedback

biofeedback 2

ACTIVE COMPARATOR

biofeedback training with progression of targets and speeds

Behavioral: biofeedback

Interventions

biofeedback BEHAVIORAL

treadmill walking with biofeedback regarding propulsion and other gait parameters

biofeedback 1; biofeedback 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Univeristy

Atlanta, Georgia, 30322, United States

Location

Related Publications (3)

• 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.

  PMID: 29457532 BACKGROUND

• 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.

  PMID: 28583196 BACKGROUND

• Santucci V, Alam Z, Liu J, Spencer J, Faust A, Cobb A, Konantz J, Eicholtz S, Wolf S, Kesar TM. Immediate improvements in post-stroke gait biomechanics are induced with both real-time limb position and propulsive force biofeedback. J Neuroeng Rehabil. 2023 Mar 31;20(1):37. doi: 10.1186/s12984-023-01154-3.

  PMID: 37004111 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Gait Disorders, Neurologic

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Trisha Kesar

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 15, 2018
• Study Start: March 22, 2018
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)