Menu
Recruiting NCT06490276

Biofeedback Gait Training on Gait Quality in Stroke

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gait training with biofeedback, Gait training without biofeedback.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Biofeedback Gait Training on Gait Quality Post-stroke

Overview

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.

Interventions

  • 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.
  • Other Gait training without biofeedback
    Gait training include treadmill and overground walking.

Primary outcome measures

  • Gait symmetry [Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up]
  • Gait variability [Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up]
Secondary outcome measures (7)
  • Propulsive force [Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up]
  • Gait performance [Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up]
  • Berg Balance Scale [Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up]
  • Activities-specific Balance Confidence Scale [Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up]
  • Taiwan Chinese version Falls Efficacy Scale [Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up]
  • Frenchay Activities Index [Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up]
  • Stroke Impact Scale [Time frame: Change from baseline at 4 weeks after training and 4 weeks follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung Uni — Taipei

Identifiers

NCT: NCT06490276 · NYCU112205AF2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗