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Treadmill With Biofeedback on Gait Symmetry After Stroke

Primary Purpose

Stroke Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treadmill with auditory feedback
Treadmill with visual feedback
Treadmill with auditory and visual feedback
Treadmill training
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Syndrome focused on measuring Gait training, Biofeedback, Treadmill, Gait symmetry

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Single stroke experience
  • Chronic stroke phase: stroke duration ≥ 6 months
  • Independent gait: Functional Ambulation Category (FAC) ≥ 3

Exclusion Criteria:

  • Cognitive problem (MMSE < 24)
  • Visual or audio deficiency that might affect training
  • Severe heart insufficiency or uncontrolled arterial hypertension
  • Orthopedic disorders that affecting their gait

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Treadmill with auditory feedback group

    Treadmill with visual feedback group

    Treadmill with auditory and visual feedback group

    Treadmill training group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Spatial and temporal gait symmetry
    Temporal symmetry ratio: 1-(single support time of affected limb/single support time of unaffected limb)

    Secondary Outcome Measures

    Walking speed
    6 Minute Walk Test
    Timed up and Go test
    Stroke Impact Scale
    quality of life

    Full Information

    First Posted
    June 14, 2020
    Last Updated
    June 18, 2020
    Sponsor
    National Yang Ming University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04441541
    Brief Title
    Treadmill With Biofeedback on Gait Symmetry After Stroke
    Official Title
    The Effects of Treadmill With Biofeedback on Gait Symmetry in Individuals With Chronic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    May 31, 2023 (Anticipated)
    Study Completion Date
    May 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Yang Ming University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to investigate the immediate, accumulated, and maintainable effects of treadmill with biofeedback on gait symmetry in individuals with chronic stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke Syndrome
    Keywords
    Gait training, Biofeedback, Treadmill, Gait symmetry

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treadmill with auditory feedback group
    Arm Type
    Experimental
    Arm Title
    Treadmill with visual feedback group
    Arm Type
    Experimental
    Arm Title
    Treadmill with auditory and visual feedback group
    Arm Type
    Experimental
    Arm Title
    Treadmill training group
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Treadmill with auditory feedback
    Intervention Description
    Participants will receive training 3 times per week for 4 weeks (12 sessions).
    Intervention Type
    Other
    Intervention Name(s)
    Treadmill with visual feedback
    Intervention Description
    Participants will receive training 3 times per week for 4 weeks (12 sessions).
    Intervention Type
    Other
    Intervention Name(s)
    Treadmill with auditory and visual feedback
    Intervention Description
    Participants will receive training 3 times per week for 4 weeks (12 sessions).
    Intervention Type
    Other
    Intervention Name(s)
    Treadmill training
    Intervention Description
    Participants will receive training 3 times per week for 4 weeks (12 sessions).
    Primary Outcome Measure Information:
    Title
    Spatial and temporal gait symmetry
    Description
    Temporal symmetry ratio: 1-(single support time of affected limb/single support time of unaffected limb)
    Time Frame
    Change from baseline at the first day, 4 weeks, and 8 weeks
    Secondary Outcome Measure Information:
    Title
    Walking speed
    Time Frame
    Change from baseline at the first day, 4 weeks, and 8 weeks
    Title
    6 Minute Walk Test
    Time Frame
    Change from baseline at the first day, 4 weeks, and 8 weeks
    Title
    Timed up and Go test
    Time Frame
    Change from baseline at the first day, 4 weeks, and 8 weeks
    Title
    Stroke Impact Scale
    Description
    quality of life
    Time Frame
    Change from baseline at the first day, 4 weeks, and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Single stroke experience Chronic stroke phase: stroke duration ≥ 6 months Independent gait: Functional Ambulation Category (FAC) ≥ 3 Exclusion Criteria: Cognitive problem (MMSE < 24) Visual or audio deficiency that might affect training Severe heart insufficiency or uncontrolled arterial hypertension Orthopedic disorders that affecting their gait
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yang Yea-Ru, PhD
    Phone
    2826-7279
    Email
    yryang@ym.edu.tw

    12. IPD Sharing Statement

    Learn more about this trial

    Treadmill With Biofeedback on Gait Symmetry After Stroke

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