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Comparing Telepractice and Conventional Face-to-face Voice Therapy

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ClinicalTrials.gov Identifier: NCT02922309
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Chi-Te Wang, Far Eastern Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Dysphonia Aged Speech Therapy Behavioral: Vocal Training Via Telepractice Behavioral: Vocal Training Via face-to face practice Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-face Therapy
Actual Study Start Date : October 17, 2016
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : December 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Voice Disorders

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




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


Other Outcome Measures:
  1. Perceptual Analysis using grade, roughness, breathiness, asthenia, and strain [ Time Frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy ]
    from 0(best) to 3(worst)

  2. Jitter [ Time Frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy ]
    percentage of jitter based on continuous vowel

  3. Shimmer [ Time Frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy ]
    decibel (dB) of shimmer based on continuous vowel

  4. Noise to harmonic ratio [ Time Frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy ]
    Noise to harmonic ratio based on continuous vowel

  5. smoothed Cepstrum peak prominence [ Time Frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy ]
    based on reading a Mandarin passage

  6. Maximal phonation time [ Time Frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy ]
    seconds

  7. VLS [ Time Frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy ]
    Videolaryngostroboscopy (mucosal wave: normal, mildly decreased, severely decreased, absent)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922309


Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
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Principal Investigator: Chi-Te Wang, MD, PhD Department of Otolaryngology, Far Eastern Memorial Hospital

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Responsible Party: Chi-Te Wang, Attending Physician, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02922309    
Other Study ID Numbers: FEMH-IRB-104193-E
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dysphonia
Communication Disorders
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurobehavioral Manifestations
Neurodevelopmental Disorders
Mental Disorders