Comparing Telepractice and Conventional Face-to-face Voice Therapy

Aged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922309
• Other study ID #: FEMH-IRB-104193-E
• Status: Completed
• Phase: N/A
• Start date: October 17, 2016
• Est. completion date: December 19, 2018

Study information

• Verified date: February 2020
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Communication Disorders
• Dysphonia
• Speech Therapy

Intervention

Behavioral:
• Vocal Training Via Telepractice
Vocal Training Via Telepractice, delivered by integrated communication service
• Vocal Training Via face-to face practice
Vocal Training Via face-to face practice at medical facilities

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Maximal phonation time	seconds	before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
Other	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
Primary	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