Clinical trial NCT02922309: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dysphonia
Aged
Speech Therapy
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 69
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change from Baseline of 10-item voice handicap index at 2 months
timeFrame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
Secondary outcomes:
Other outcomes:
measure: Perceptual Analysis using grade, roughness, breathiness, asthenia, and strain
timeFrame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
measure: Jitter
timeFrame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
measure: Shimmer
timeFrame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
measure: Noise to harmonic ratio
timeFrame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
measure: smoothed Cepstrum peak prominence
timeFrame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
measure: Maximal phonation time
timeFrame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
measure: VLS
timeFrame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
Locations:
Study officials:
affiliation: Department of Otolaryngology, Far Eastern Memorial Hospital
name: Chi-Te Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.