Kinematic Biofeedback on Gait Quality in Stroke

NCT ID: NCT06504836

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Gait training with biofeedback group

The intervention is a single 60-minute session.

Group Type EXPERIMENTAL

Gait training with biofeedback

Intervention Type 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 group

The intervention is a single 60-minute session.

Group Type ACTIVE_COMPARATOR

Gait training without biofeedback

Intervention Type OTHER

Gait training include treadmill and overground walking.

Interventions

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Gait training with biofeedback

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

Intervention Type OTHER

Gait training without biofeedback

Gait training include treadmill and overground walking.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Yea-Ru Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yea-Ru Yang, PhD

Role: CONTACT

+886228267279

Facility Contacts

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Yea-Ru Yang, PhD

Role: primary

+886-2-2826-7279

Other Identifiers

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NYCU112205AF1

Identifier Type: -

Identifier Source: org_study_id

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