Kinematic Biofeedback on Gait Quality in Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Gait training without biofeedback; Other: Gait training with biofeedback

• Registration Number: NCT06504836
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-30
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-17
• Study Start: 2024-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-22
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gait training without biofeedback group	Gait training without biofeedback	The intervention is a single 60-minute session.
Gait training with biofeedback group	Gait training with biofeedback	The intervention is a single 60-minute session.

Primary Outcome Measures

Name	Time	Method
Gait symmetry	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	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 Outcome Measures

Name	Time	Method
Propulsive force	1 day	Using Force plate to measure the ground reaction force

Trial Locations

Locations (1)

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan