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
About this trial
This is an interventional treatment trial for Dysphonia
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
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
NCT ID
NCT02922309
First Posted
September 23, 2016
Last Updated
February 25, 2020
Sponsor
Far Eastern Memorial Hospital
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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