NCT06504836

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

June 30, 2024

Last Update Submit

February 22, 2025

Conditions

Stroke

Keywords

BiofeedbackGait symmetryGait variability

Outcome Measures

Primary Outcomes (2)

  • Gait symmetry

    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.

    1 day

  • Gait variability

    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%

    1 day

Secondary Outcomes (1)

  • Propulsive force

    1 day

Study Arms (2)

Gait training with biofeedback group

EXPERIMENTAL

The intervention is a single 60-minute session.

Other: Gait training with biofeedback

Gait training without biofeedback group

ACTIVE COMPARATOR

The intervention is a single 60-minute session.

Other: Gait training without biofeedback

Interventions

Gait training with biofeedbackOTHER

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

Gait training with biofeedback group
Gait training without biofeedbackOTHER

Gait training include treadmill and overground walking.

Gait training without biofeedback group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

+886228267279yryang@nycu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2024

First Posted

July 17, 2024

Study Start

October 1, 2024

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations

TW(1)