Clinical trial NCT03129880: Intensive Versus Traditional Voice Therapy
Official title: Voice-related Outcomes in Response to Intensive Versus Traditional Therapy Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphonia
Keywords: Voice disorder
Hoarseness
Phonation Disorders
Speech Disorders
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For purposes of this study participants will be randomized into one of the following two groups:

4-6 weekly standard of care therapy sessions, once a week, for a maximum of six weeks 4-6 standard of care therapy sessions in one day Standard of care treatment may continue past patient enrollment in this study.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there are differences in treatment outcomes between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive voice therapy, consisting of 4-6 therapy sessions performed within one day.

Detailed description: The goal of voice therapy is optimal long-term vocal quality and communication function with minimal recurrence. Traditional voice therapy for dysphonia typically consists of one to two therapy sessions each week with a single clinician for about 8 weeks. Another approach of voice therapy is intensive short-term therapy also known as "boot camp." This approach, borrows from the disciplines of neurobiology, exercise physiology, motor learning, and psychotherapy which describe desirable learning and behavior changes influenced by practice that involves high-intensity overload, variability, and specificity of training. A few studies have showed that "Boot Camp" model of intensive therapy resulted in comparable gains in voice quality and vibratory mechanics and may promote better patient satisfaction and attendance.

While such findings support the notion that intensive voice therapy may enhance voice therapy outcomes, no study to date has examined patient response to the "Boot Camp" approach to voice therapy. The investigators will compare the outcomes of traditional, weekly voice therapy and intensive voice therapy with multiple sessions in one day.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with a Voice disorder
* Diagnosed with benign vocal fold lesions and/or hyper-function
* First/primary propose treatment modality is voice therapy
* Patients who are appropriate for either standard of care treatment modality (traditional or intensive voice therapy)
* Willingness to participate in either standard of care treatment modality
* All races
* Males and females
* English speaking

Exclusion Criteria:

* Younger than 18
* Inability or unwillingness to participate in one of the standard of care treatment modalities
* Laryngeal Surgery or procedures during course of study
* Prisoners

Primary outcomes:
measure: Self-efficacy and readiness scale Changes
timeFrame: Baseline compared to Immediately post voice therapy
measure: Self-efficacy and readiness scale Change
timeFrame: Baseline compared to 12 weeks post voice therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison Voice and Swallow Clinic
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Emerald J Doll, MS, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: