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Clinical Trials/NCT06490276
NCT06490276
Recruiting
Not Applicable

Effects of Biofeedback Gait Training on Gait Quality Post-stroke

National Yang Ming Chiao Tung University1 site in 1 country40 target enrollmentOctober 1, 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
National Yang Ming Chiao Tung University
Enrollment
40
Locations
1
Primary Endpoint
Gait symmetry
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
December 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yea-Ru Yang

Professor

National Yang Ming Chiao Tung University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Gait symmetry

Time Frame: Change from baseline at 4 weeks after training and 4 weeks follow-up

Using GAITRite system to measure the symmetry of saptiotemporal parameters

Gait variability

Time Frame: Change from baseline at 4 weeks after training and 4 weeks follow-up

Using GAITRite system to measure the coefficient of variation of saptiotemporal parameters

Secondary Outcomes

  • Propulsive force(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Stroke Impact Scale(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Gait performance(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Berg Balance Scale(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Activities-specific Balance Confidence Scale(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Taiwan Chinese version Falls Efficacy Scale(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Frenchay Activities Index(Change from baseline at 4 weeks after training and 4 weeks follow-up)

Study Sites (1)

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