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NCT Number: NCT06504836

Kinematic Biofeedback on Gait Quality in Stroke

Walking disorder is the most common and concerning issue for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for the advancement of gait performance in individuals with stroke. However, for individuals with chronic stroke, considering gait symmetry and variability to enhance gait quality as the primary intervention target may be more crucial. According to a literature review, it can be inferred that the application of biofeedback to detect gait quality may be an effective approach to improve gait symmetry and variability in individuals with stroke. However, there is still insufficient research evidence on this issue. Therefore, this study aims to investigate the effects of a kinematic biofeedback device system, which detects hip joint angles, on gait quality in individuals with chronic 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: 1 day

    Using GAITRite system to measure the symmetry of spatiotemporal parameters, including step length, step width, single support time, and double support time. Calculate the gait symmetry using following formula:

    Gait symmetry = affected side/ unaffected side.

  2. Gait variability

    Time frame: 1 day

    Using GAITRite system to measure the coefficient of variation (CV). The mean and standard deviation will be used to calculate the coefficient of variation (CV).

    CV = standard deviation / mean * 100%

Secondary outcomes

  1. Propulsive force

    Time frame: 1 day

    Using Force plate to measure the ground reaction force

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 Kinematic Biofeedback on Gait Quality in People With Stroke

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 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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