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Immediate Effects of Talus-Stabilizing Taping on Balances and Gait Parameters in Chronic Stroke Patients

Status Approved

  • First Submitted Date

    2017/04/24

  • Registered Date

    2017/05/19

  • Last Updated Date

    2017/05/15

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002335
    Unique Protocol ID 1041849-201610-BM-055-02
    Public/Brief Title Immediate Effects of Talus-Stabilizing Taping on Balances and Gait Parameters in Chronic Stroke Patients
    Scientific Title Immediate Effects of Talus-Stabilizing Taping on Balances and Gait Parameters in Chronic Stroke Patients
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 1041849-201610-BM-055-02
    Approval Date 2016-11-01
    Institutional Review Board Name Yonsei University Wonju Institutional Review Board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Heon-seock Cynn
    Title PhD.
    Telephone +82-33-760-2427
    Affiliation Yonsei University
    Address Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
    Contact Person for Public Queries
    Name DONGHWAN PARK
    Title Mr.
    Telephone +82-32-899-4559
    Affiliation Yonsei University
    Address Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
    Contact Person for Updating Information
    Name DONGHWAN PARK
    Title Mr.
    Telephone +82-32-899-4559
    Affiliation Yonsei University
    Address Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2016-11-14 Actual
    Target Number of Participant 20
    Primary Completion Date 2016-11-18 , Actual
    Study Completion Date 2016-11-30 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Gyeongin Rehabilitaion Center Hospital
    Recruitment Status Completed
    Date of First Enrollment 2016-11-14 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Yonsei University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Objective Our objective is to compare the immediate effects of ankle talus-stabilizing taping with those of barefoot and conventional ankle-foot orthosis on balance and gait parameters in patients with chronic stroke.
    
    Background: Stroke is currently the leading cause of long-term disability because of the sequelae experienced by patients with stroke, which further impairs lower limb function and thus influences walking. There are many training approaches for improving balance and gait performance through reducing the ankle plantar flexor passive resistance using assistive treatment methods, such as robotic devices, functional electric stimulation, ankle-foot orthoses, and ankle mobilization with movement.Talus-stabilizing taping can be used to improve ankle range of motion and gait performance because it provides a posterior-inferior talar glide in a closed-chain dorsiflexion position. No previous studies have investigated the usefulness of  talus-stabilizing taping  in patients with chronic stroke. Recent studies reported that talus-stabilizing taping improves ankle range of motion and gait performance because talus-stabilizing taping provides a posterior-inferior talar glide in a closed-chain dorsiflexion position 
    
    Hypothesize : We hypothesized that talus-stabilizing taping  would improve static balance ability, timed up and go test, gait parameters in the patients with chronic stroke. 
    
    Plan : The order of conditions (talus-stabilizing taping , barefoot, and conventional ankle-foot orthosis) was determined using the web randomization site, and each patient performed the tests under the three conditions in random order to avoid bias through learning or fatigue. An experienced physical therapist was blinded to the patient intervention assignments and study hypotheses, limiting the potential for expectation bias. The patient characteristics and all outcome (static balance ability, timed up and go test, and gait parameters) measures were assessed by the same physical therapist. The measurements were repeated three times, and the mean value was calculated. 
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase3
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    The order of conditions (talus-stabilizing taping, barefoot, and conventional ankle-foot orthosis (S, M, L size)) was determined using the web randomization site, and each patient performed the tests under the three conditions in random order.
    The patient characteristics and all outcome (static balance ability, timed up and go test, and gait parameters) measures were assessed by the physical therapist.
    Number of Arms 1
    Arm 1

    Arm Label

    experimental group

    Target Number of Participant

    20

    Arm Type

    Experimental

    Arm Description

    The order of conditions (TST, barefoot, and conventional AFO) was determined using the web randomization site, http://www.randomization.com, and each patient performed the tests under the three conditions in random order. 
    1) For the talus-stabilizing taping, the patients placed the affected side ankle on the chair and advanced the tibia over the foot via knee flexion. An experienced physical therapist used protective under-tapes. A rigid strapping tape (37 mm width, Mueller M tape) was applied from the talus of the affected side ankle (passing below the medial and lateral malleolus) to the plantar surface of the calcaneus through the medial and lateral sides of the talus using maximal force with the tape.
    2) The conventional ankle-foot orthosis used in this study was a standard, off-the-shelf, posterior leaf type, with a setting in neutral position. The orthosis came in three different sizes, and the one that best fitted each patient was used.
    3) Measurements were made with bare feet. 
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I64)Stroke, not specified as haemorrhage or infarction 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    43Year~78Year

    Description

    (1) diagnosis of hemiplegia due to hemorrhagic or ischemic stroke; more than 6 months post-stroke to minimize the effects of natural recovery; 
    (2) independent gait possible over 10 m without assistive devices
    (3) minimum score of 24 on the Korean Mini-Mental State Examination 
    (4) spasticity in a lower affected side ankle (Modified Ashworth scale≤1)
    (5) no orthopedic problems involving the lower extremities that would affect gait.
    Exclusion Criteria
    (1) medical problems other than neurological lesions that affected the gait patterns
    (2) bilateral affected limbs
    (3) premorbid or current orthopedic problem involving the lower extremities.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    static balance ability
    Timepoint
    The patients performed the tests for 10 min to familiarize themselves with the three conditions until a proper motion in walking was achieved at a comfortable speed. A 5-min resting period was allowed after the familiarization period and before the data collection began. 
    Primary Outcome(s) 2
    Outcome
    Timed up and go test
    Timepoint
    The patients performed the tests for 10 min to familiarize themselves with the three conditions until a proper motion in walking was achieved at a comfortable speed. A 5-min resting period was allowed after the familiarization period and before the data collection began. 
    Secondary Outcome(s) 1
    Outcome
    gait parameters
    Timepoint
    The patients performed the tests for 10 min to familiarize themselves with the three conditions until a proper motion in walking was achieved at a comfortable speed. A 5-min resting period was allowed after the familiarization period and before the data collection began
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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