Comparing Telepractice and Conventional Face-to-face Voice Therapy
25. februar 2020 opdateret af: Chi-Te Wang, Far Eastern Memorial Hospital
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
69
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: experimental
Vocal Training via Telepractice
|
Vocal Training Via Telepractice, delivered by integrated communication service
|
|
Aktiv komparator: control
Vocal Training via face-to-face practice
|
Vocal Training Via face-to face practice at medical facilities
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline of 10-item voice handicap index at 2 months
Tidsramme: 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);
|
before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceptual Analysis using grade, roughness, breathiness, asthenia, and strain
Tidsramme: 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)
|
before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
|
|
Jitter
Tidsramme: 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
|
before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
|
|
Shimmer
Tidsramme: 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
|
before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
|
|
Noise to harmonic ratio
Tidsramme: 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
|
before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
|
|
smoothed Cepstrum peak prominence
Tidsramme: 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
|
before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
|
|
Maximal phonation time
Tidsramme: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
|
seconds
|
before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
|
|
VLS
Tidsramme: 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)
|
before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Chi-Te Wang, MD, PhD, Department of Otolaryngology, Far Eastern Memorial Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. oktober 2016
Primær færdiggørelse (Faktiske)
19. december 2018
Studieafslutning (Faktiske)
19. december 2018
Datoer for studieregistrering
Først indsendt
23. september 2016
Først indsendt, der opfyldte QC-kriterier
30. september 2016
Først opslået (Skøn)
4. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FEMH-IRB-104193-E
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Vocal Training Via Telepractice
-
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