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Comparing Telepractice and Conventional Face-to-face Voice Therapy

Primary Purpose

Dysphonia, Aged, Speech Therapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vocal Training Via Telepractice
Vocal Training Via face-to face practice
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphonia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • patient equal or older than 55 years old
  • Voice Handicap Index-10 (VHI-10) score >10 point
  • accessibility to a network connection

Exclusion criteria

  • neurologic disorders
  • active pulomanory disease
  • mental disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    experimental

    control

    Arm Description

    Vocal Training via Telepractice

    Vocal Training via face-to-face practice

    Outcomes

    Primary Outcome Measures

    Change from Baseline of 10-item voice handicap index at 2 months
    min: 0(best); Max: 40(worst);

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 2016
    Last Updated
    February 25, 2020
    Sponsor
    Far Eastern Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02922309
    Brief Title
    Comparing Telepractice and Conventional Face-to-face Voice Therapy
    Official Title
    Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-face Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 17, 2016 (Actual)
    Primary Completion Date
    December 19, 2018 (Actual)
    Study Completion Date
    December 19, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Far Eastern Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal training in order to improve communication efficiency and quality of life. However, participation in vocal training of elderly is often restricted by motivation, time of practice, and availability to hospital, which thus reduces treatment effects. The purpose of the study is to design a telecommunication vocal training system and a vocal training program for voice disordered elderly in Taiwan. The investigator proposed a 3-year consecutive study, including a single-blind, randomized controlled trial, to test the hypothesis that vocal training via telepractice for voice disordered elderly are not inferior to the standard face to face training.
    Detailed Description
    Randomization: per mutated block, 40 patients on each arms (experimental and control) Allocation: sealed envelope indicating either of the 2 groups Intervention: weekly vocal training, each course last for 30-40 minutes,lasting for 2 months Outcome measurement: before treatment, 1 month, 3 months, and 6 months after treatment Primary outcome: 10-item voice handicap index Secondary outcome: acoustics and aerodynamic parameter

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphonia, Aged, Speech Therapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    experimental
    Arm Type
    Experimental
    Arm Description
    Vocal Training via Telepractice
    Arm Title
    control
    Arm Type
    Active Comparator
    Arm Description
    Vocal Training via face-to-face practice
    Intervention Type
    Behavioral
    Intervention Name(s)
    Vocal Training Via Telepractice
    Intervention Description
    Vocal Training Via Telepractice, delivered by integrated communication service
    Intervention Type
    Behavioral
    Intervention Name(s)
    Vocal Training Via face-to face practice
    Intervention Description
    Vocal Training Via face-to face practice at medical facilities
    Primary Outcome Measure Information:
    Title
    Change from Baseline of 10-item voice handicap index at 2 months
    Description
    min: 0(best); Max: 40(worst);
    Time Frame
    before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
    Other Pre-specified Outcome Measures:
    Title
    Perceptual Analysis using grade, roughness, breathiness, asthenia, and strain
    Description
    from 0(best) to 3(worst)
    Time Frame
    before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
    Title
    Jitter
    Description
    percentage of jitter based on continuous vowel
    Time Frame
    before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
    Title
    Shimmer
    Description
    decibel (dB) of shimmer based on continuous vowel
    Time Frame
    before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
    Title
    Noise to harmonic ratio
    Description
    Noise to harmonic ratio based on continuous vowel
    Time Frame
    before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
    Title
    smoothed Cepstrum peak prominence
    Description
    based on reading a Mandarin passage
    Time Frame
    before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
    Title
    Maximal phonation time
    Description
    seconds
    Time Frame
    before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
    Title
    VLS
    Description
    Videolaryngostroboscopy (mucosal wave: normal, mildly decreased, severely decreased, absent)
    Time Frame
    before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: patient equal or older than 55 years old Voice Handicap Index-10 (VHI-10) score >10 point accessibility to a network connection Exclusion criteria neurologic disorders active pulomanory disease mental disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chi-Te Wang, MD, PhD
    Organizational Affiliation
    Department of Otolaryngology, Far Eastern Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32579859
    Citation
    Lin FC, Chien HY, Chen SH, Kao YC, Cheng PW, Wang CT. Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-Face Therapy. J Speech Lang Hear Res. 2020 Jul 20;63(7):2132-2140. doi: 10.1044/2020_JSLHR-19-00364. Epub 2020 Jun 24.
    Results Reference
    derived

    Learn more about this trial

    Comparing Telepractice and Conventional Face-to-face Voice Therapy

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