Intensive Versus Traditional Voice Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03129880|
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : August 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dysphonia||Behavioral: Weekly Voice Therapy Behavioral: Intensive Voice Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|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.
|Masking:||None (Open Label)|
|Official Title:||Voice-related Outcomes in Response to Intensive Versus Traditional Therapy Programs|
|Actual Study Start Date :||March 13, 2016|
|Estimated Primary Completion Date :||March 12, 2021|
|Estimated Study Completion Date :||March 12, 2021|
Placebo Comparator: Weekly Voice Therapy
Participants are randomized to receiving weekly voice therapy sessions
Behavioral: Weekly Voice Therapy
Participants will be randomized to receive weekly voice therapy
Active Comparator: Intensive Voice Therapy
Participants are randomized to receiving multiple sessions of voice therapy in one day
Behavioral: Intensive Voice Therapy
Participants will be randomized to receive multiple sessions of voice therapy in one day.
- Self-efficacy and readiness scale Changes [ Time Frame: Baseline compared to Immediately post voice therapy ]Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
- Self-efficacy and readiness scale Change [ Time Frame: Baseline compared to 12 weeks post voice therapy ]Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
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): NCT03129880
|Contact: Emerald J Doll, MS, CCC-SLPemail@example.com|
|Contact: Katherine McConville, MA, CCC-SLPfirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin-Madison Voice and Swallow Clinic||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Emerald Doll, MS 608-262-5213 email@example.com|
|Principal Investigator: Emerald Doll, MS|
|Sub-Investigator: Katherine McConville, MA|