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Clinical Trials/NCT06504836
NCT06504836RecruitingNot Applicable

Effects of Kinematic Biofeedback on Gait Quality in People With Stroke

National Yang Ming Chiao Tung University2 sites in 1 country40 target enrollmentStarted: October 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
2
Primary Endpoint
Gait symmetry

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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: 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.

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

  • Propulsive force(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yea-Ru Yang

Professor

National Yang Ming Chiao Tung University

Study Sites (2)

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