Biofeedback Gait Training on Gait Quality in Stroke

Effects of Biofeedback Gait Training on Gait Quality Post-stroke

Post-stroke gait dysfunction is characterized by reduced gait velocity and stride length, along with gait asymmetry and instability. Gait asymmetry and instability are considered as indicators for gait quality, which affect independence and quality of life in individual with stroke. Previous studies have suggested that gait biofeedback is a promising strategy for enhancing the efficacy of post-stroke gait training. However, there is insufficient evidence on the effects of kinematic biofeedback gait training on gait asymmetry and instability in individuals with stroke. Therefore, the purpose of this study is to investigate the effects of real-time kinematic gait biofeedback training on gait quality in individuals with stroke.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Gait training with biofeedback; Other: Gait training without biofeedback

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yea-Ru Yang, PhD; Phone Number: +886228267279; Email: yryang@nycu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
    • Contact: Yea-Ru Yang, PhD; Phone Number: +886-2-2826-7279; Email: yryang@nycu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• First stroke
• Stroke onset time ≥ 6 months
• Functional Ambulation Category ≥3
• Passive range of motion of affected hip extension is at least 10 degrees
• Mini-Mental State Measurement score ≥ 24 points

Exclusion Criteria:

• Modified Ashworth Scale of affected ankle plantar flexors ≥ 2
• Muscle strength of affected ankle plantar flexors via Manual Muscle Testing ≤ 1
• Uncorrected auditory impairment
• Severe cardiovascular disease or uncontrolled hypertension
• Other orthopedic diseases that may affect walking ability
• Other neurological disease except stroke

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gait training with biofeedback group; The intervention is a 60-minute session and 3 sessions/week, totaling 4 weeks.	Other: Gait training with biofeedback; Gait training include treadmill and overground walking. The biofeedback device system will provide real-time feedback on hip extension angles.
Active Comparator: Gait training without biofeedback group; The intervention is a 60-minute session and 3 sessions/week, totaling 4 weeks.	Other: Gait training without biofeedback; Gait training include treadmill and overground walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait symmetry	Using GAITRite system to measure the symmetry of saptiotemporal parameters	Change from baseline at 4 weeks after training and 4 weeks follow-up
Gait variability	Using GAITRite system to measure the coefficient of variation of saptiotemporal parameters	Change from baseline at 4 weeks after training and 4 weeks follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propulsive force	Using Force plate to measure the ground reaction force	Change from baseline at 4 weeks after training and 4 weeks follow-up
Gait performance	Using the GAITRite system to evaluate saptiotemporal parameters	Change from baseline at 4 weeks after training and 4 weeks follow-up
Berg Balance Scale	Using Berg Balance Scale to evaluate balance ability	Change from baseline at 4 weeks after training and 4 weeks follow-up
Activities-specific Balance Confidence Scale	Using Activities-specific Balance Confidence Scale to evaluate individual's balance confidence in performing daily activities	Change from baseline at 4 weeks after training and 4 weeks follow-up
Taiwan Chinese version Falls Efficacy Scale	Using Taiwan Chinese version Falls Efficacy Scale to evaluate concerns about falling	Change from baseline at 4 weeks after training and 4 weeks follow-up
Frenchay Activities Index	Using Frenchay Activities Index to measure individual's capacity to perform instrumental activities of daily living	Change from baseline at 4 weeks after training and 4 weeks follow-up
Stroke Impact Scale	Using Stroke Impact Scale to evaluate disability and quality of life after stroke	Change from baseline at 4 weeks after training and 4 weeks follow-up

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: June 30, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 22, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Biofeedback; Gait training; Gait symmetry; Gait variability
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: NYCU112205AF2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No