Comparing Telepractice and Conventional Face-to-face Voice Therapy

Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-face Therapy

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.

Study Overview

• Status: Completed
• Conditions: Aged; Dysphonia; Speech Therapy
• Intervention / Treatment: Behavioral: Vocal Training Via Telepractice; Behavioral: Vocal Training Via face-to face practice

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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; Vocal Training via Telepractice	Behavioral: Vocal Training Via Telepractice; Vocal Training Via Telepractice, delivered by integrated communication service
Active Comparator: control; Vocal Training via face-to-face practice	Behavioral: Vocal Training Via face-to face practice; Vocal Training Via face-to face practice at medical facilities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of 10-item voice handicap index at 2 months	min: 0(best); Max: 40(worst);	before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceptual Analysis using grade, roughness, breathiness, asthenia, and strain	from 0(best) to 3(worst)	before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
Jitter	percentage of jitter based on continuous vowel	before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
Shimmer	decibel (dB) of shimmer based on continuous vowel	before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
Noise to harmonic ratio	Noise to harmonic ratio based on continuous vowel	before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
smoothed Cepstrum peak prominence	based on reading a Mandarin passage	before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
Maximal phonation time	seconds	before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
VLS	Videolaryngostroboscopy (mucosal wave: normal, mildly decreased, severely decreased, absent)	before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Chi-Te Wang, MD, PhD, Department of Otolaryngology, Far Eastern Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2016
• Primary Completion (Actual): December 19, 2018
• Study Completion (Actual): December 19, 2018

Study Registration Dates

• First Submitted: September 23, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Otorhinolaryngologic Diseases; Neurodevelopmental Disorders; Laryngeal Diseases; Voice Disorders; Dysphonia; Communication Disorders
• Other Study ID Numbers: FEMH-IRB-104193-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No