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NCT Number: NCT06490276

Biofeedback Gait Training on Gait Quality in 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location status: Recruiting

Location contact

Yea-Ru Yang, PhD

CONTACT

[email protected]

+886-2-2826-7279

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gait training with biofeedback

Other

Gait training include treadmill and overground walking. The biofeedback device system will provide real-time feedback on hip extension angles.

Gait training without biofeedback

Other

Gait training include treadmill and overground walking.

Primary outcomes

  1. 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

  2. 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

  1. Propulsive force

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

    Using Force plate to measure the ground reaction force

  2. Gait performance

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

    Using the GAITRite system to evaluate saptiotemporal parameters

  3. Berg Balance Scale

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

    Using Berg Balance Scale to evaluate balance ability

  4. Activities-specific Balance Confidence Scale

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

    Using Activities-specific Balance Confidence Scale to evaluate individual's balance confidence in performing daily activities

  5. Taiwan Chinese version Falls Efficacy Scale

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

    Using Taiwan Chinese version Falls Efficacy Scale to evaluate concerns about falling

  6. Frenchay Activities Index

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

    Using Frenchay Activities Index to measure individual's capacity to perform instrumental activities of daily living

  7. Stroke Impact Scale

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

    Using Stroke Impact Scale to evaluate disability and quality of life after stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Yea-Ru Yang, PhD

CONTACT

[email protected]

+886228267279

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Effects of Biofeedback Gait Training on Gait Quality Post-stroke

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2024
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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