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Clinical Trials/NCT03700684
NCT03700684
Completed
Not Applicable

A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease

University of Massachusetts, Amherst2 sites in 1 country36 target enrollmentSeptember 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Parkinson Disease
Sponsor
University of Massachusetts, Amherst
Enrollment
36
Locations
2
Primary Endpoint
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study addresses several issues related to the clinical management of speech and voice disorders associated with Parkinson's disease. Two behavioral treatment programs, Lee Silverman Voice Treatment and SpeechVive, are assessed in their ability to improve communication in persons with Parkinson's disease.

Detailed Description

Surgical and pharmacological management of the motor-based symptoms of PD has made great strides over the last few decades. The behavioral management of the speech and voice symptoms however, has not grown by the same leaps and bounds. Despite the prevalence of speech and voice symptoms associated with PD, few evidence-based treatment options are currently available. In the face of good efficacy data, the Lee Silverman Voice Treatment (LSVT LOUD) program continues to be the gold standard for voice treatment. LSVT LOUD trains patients to monitor and adjust their vocal intensity when they perceive that their voice is soft. Therefore, the success of LSVT LOUD is predicated, in part, on an individual's ability to self-monitor and self-cue (internal cueing) during speech production. While LSVT LOUD has fostered significant improvements in communication for many patients with PD, not all patients respond to treatment. It has been postulated that underlying sensory and cognitive factors may hinder treatment outcomes. A new behavioral treatment for speech and voice impairment has recently been introduced. The SpeechVive, a small in-the-ear device, uses an external noise cue to elicit louder speech. While LSVT LOUD and the SpeechVive have both been shown to significantly increase sound pressure level (SPL) in patients with PD, the physiologic adjustments supporting these changes in SPL remain unclear. This is an important area of study for two reasons. First, both treatments are exercised-based programs, yet the physiologic changes associated with these treatments are not well understood. Second, there is evidence to suggest that the use of an external cue, such as the noise cue used in SpeechVive training, elicits more efficient respiratory patterns in neurologically-healthy and neurologically-involved patients, in comparison to self-initiated cueing strategies, such as those used in LSVT LOUD. This study proposes to compare the influence of cueing strategy on treatment outcomes by examining simultaneous respiratory-laryngeal adjustments before and after participation in LSVT LOUD (internal cueing) and SpeechVive (external cueing) training. It is important to study respiratory-laryngeal interactions because both of these subsystems contribute to vocal intensity regulation. In addition, exercise physiology studies have indicated that internal and external forms of cueing elicit different perceptions of physical and mental effort during exercise. It is important to understand the patients' level of perceived physical and mental effort, associated with each treatment program, as these variables can effect adherence to the treatment regime. In summary, the proposed study is intended to 1) fill a critical void in the investigator's understanding of respiratory-laryngeal adjustments used to support increased SPL under two evidence-based behavioral voice treatment programs, and 2) to better understand how patients' perceptions of physical and mental effort are shaped by each treatment paradigm. The information generated in this study could potentially lead to more efficient voice rehabilitation for persons with PD.

Registry
clinicaltrials.gov
Start Date
September 19, 2018
End Date
November 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelly Richardson

Associate Professor

University of Massachusetts, Amherst

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Parkinson's disease
  • Problems with speech loudness due to Parkinson's disease
  • No asthma or other respiratory problems
  • No head, neck or chest surgery (Pacemaker surgery is okay)
  • Non-smoking for the last 5 years
  • Not currently participating in another treatment study
  • Typical cognitive skills
  • Free of symptoms of depression
  • Unaided hearing in at least one ear
  • No voice therapy or voice therapy maintenance within the last 12 months

Exclusion Criteria

  • Other neurological diseases, other than Parkinson's disease
  • History of asthma or respiratory problems
  • Head, neck or chest surgery
  • Smoker within the last 5 years
  • Currently involved in another treatment study
  • Decreased cognition
  • Symptoms of depression
  • Wear a hearing aid in both ears
  • Participated in voice therapy within the last 12 months.

Outcomes

Primary Outcomes

Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.

Time Frame: Change from baseline after 8 weeks of treatment

Changes in speech breathing will be assessed by examining movement in the ribcage and abdominal walls (respiratory kinematics) during speech. Non-invasive elasticized bands are fitted around the chest and abdominal walls to monitor movement. Respiratory kinematic measures will be in percentage of vital capacity relative to end-expiratory level. Negative values for lung volume termination indicate that speech was terminated below end-expiratory level. Positive values for lung volume termination indicate that speech was terminated above end-expiratory level. The data reported show the baseline and post-treatment values for lung volume initiation, termination, and excursion as a percentage of vital capacity relative to end-expiratory level.

Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index

Time Frame: Change from baseline after 8 weeks of treatment

Ratings of physical and mental effort will be assigned by participants on treatment days using the modified NASA-Task Load Index. Participants rate how much physical effort and mental effort it took to complete treatment each day. Participants will indicate their response using a visual analogue scale (0-100) with the endpoints "no effort" ("0") to "significant effort" ("100"). Data are not reported for the clinical control group as these participants did not receive treatment. Ratings of mental and physical effort are reported separately at baseline and post-treatment.

Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient)

Time Frame: Change from baseline after 8 weeks of treatment

Movement of air through the vocal folds will also be assessed during a vowel and sentence production task using a vented mask that fits over the nose and mouth. This allows us to derive estimates of how long the vocal folds are open (open quotient). Pre-treatment and post-treatment values are reported. Open quotient is a unit-less measure.

Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR)

Time Frame: Change from baseline after 8 weeks of treatment

Movement of air through the vocal folds will also be assessed during a vowel and sentence production task using a vented mask that fits over the nose and mouth. This allows us to derive estimates of how quickly the vocal folds are closing (maximum flow declination rate). Pre-treatment and post-treatment values are reported. Maximum flow declination rate (MFDR) is reported in liters per second per second (L/s/s).

Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis.

Time Frame: Change from baseline after 8 weeks of treatment

Vocal intensity (dB SPL) will be measured during a reading task and a monologue task. The vocal intensity data reported will be collapsed across the reading and monologue task. Recorded speech samples are captured using a head-mounted microphone. The speech signals are analyzed for vocal intensity using Praat. The pre- to post-treatment change in vocal intensity is reported in decibels. A positive value indicates an increase in vocal intensity post-treatment. A negative value indicates a decrease in vocal intensity post-treatment. We expected to see no change in vocal intensity for the control group as they did not receive voice intervention.

Secondary Outcomes

  • Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire(Change from baseline after 8 weeks of treatment)
  • Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis.(Change from baseline after 8 weeks of treatment)
  • Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis.(Change from baseline after 8 weeks of treatment)
  • Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39)(Change from baseline after 8 weeks of treatment)
  • Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire(Change from baseline after 8 weeks of treatment)

Study Sites (2)

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