The Effect of Combined Speech and Music-therapy on the Speech Characteristics of People With Parkinson's Disease (PD)

Comparison of The Effect of Speech Therapy , Music-therapy and Combined Speech and Music Therapy on the Vocal Characteristics of People With PD by Using Telerehabilitation

Speech and voice disorders are observed in almost 90% of patients with PD during their course of illness. Reduced voice pitch inflections or monotone speech, reduced vocal loudness, prosody disorders, the imprecise articulation of the consonants, hoarseness, and breathy voice is also observed in patients with PD; these symptoms often lead to reduced speech intelligibility. The aim of this study will to investigate the possible changes in the voice and speech features in people with PD after a combined speech and music therapy using Telerehabilitation.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Speech Disorders; Voice Disorders
• Intervention / Treatment: Behavioral: combined speech and music therapy; Behavioral: speech therapy; Behavioral: music therapy

Detailed Description

the investigators of this study propose to conduct a pilot randomized, controlled trial in patients with PD to assess the potential effectiveness of a Telerehabilitation intervention that encourage a higher level of speech performance. The investigators hypothesize that patients in the combined treatment group will have more and better improve in the study outcome measures after treatment and 3 month follow up, as compared with patients in speech therapy group and music therapy group.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeinab Mohseni; Phone Number: 0098 9188431500; Email: zeynab_mohseny@yahoo.com
• Study Contact Backup: Name: Reyhaneh Mohammadi; Phone Number: 0098 912 525 4951; Email: mohamadi.re88@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Iran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with idiopathic Parkinson's disease (IPD)
• Patients who are in stages 1-3 according to Hoehn & Yahr test
• Native language is persian
• The patient or family complains about the person's speech condition
• Adequate vision and hearing
• No history of stroke, head injury, brain surgery, laryngeal diseases such as vocal cord nodules
• No other neurological disorders other than IPD
• Do not use treatment other than medication (such as deep brain stimulation surgery (DBS)
• informed consent

Exclusion Criteria:

• If a patient develops a stroke or other neurological complication during treatment, they are excluded from the treatment
• Lack of cooperation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combined speech and music therapy; the telerehabilitation intervention that include both speech therapy and music therapy at the same time	Behavioral: combined speech and music therapy; he telerehabilitation intervention that include both speech therapy and music therapy at the same time
Active Comparator: speech therapy; A behavioural speech therapy program including breathing exercises, loudness, pitch, and intelligibility which are adapted from Lee Silverman Voice Treatment (LSVT) and voice exercises Which is delivered through telerehabilitation	Behavioral: speech therapy; A behavioural speech therapy program including breathing exercises, loudness, pitch, and intelligibility which are adapted from Lee Silverman Voice Treatment (LSVT) and voice exercises Which is delivered through telerehabilitation
Active Comparator: music therapy; music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation	Behavioral: music therapy; music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
loudness	Change in loudness over the period of the study which will be based on analysis of acoustic recordings. Loudness of voice will be measured in produce the vowel /a /, reading and spontaneous speech. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals.	Change from Baseline in loudness at 4 weeks and 3 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voice Handicap Index (VHI)	Change in Persian version of Voice Handicap Index (VHI) over the period of the study. The VHI measures the influence of voice problems on a patient's quality of life. The VHI is a 30 item scale. The total scores range is 0-120. A score 60-120 indicates severe voice problem.	Change from Baseline in VHI at 4 weeks and 3 month follow up
maximum phonation time (MPT)	Change in maximum phonation time (MPT) over the period of the study. MPT will be measured by asking the subject to produce the long vowel /a/. This vocalization is measured three times, and the longest MPT is recorded.	Change from Baseline in MPT at 4 weeks and 3 month follow up
Speech Intelligibility	Change in fudalla speech intelligibility rating scale over the period of the study. This scale consists of 7 rates in which the number 1 indicates Speech is not intelligible and number 7 indicates Speech is totally intelligible.	Change from Baseline in Speech Intelligibility at 4 weeks and 3 month follow up
Swallowing Disturbance Questionnaire (SDQ)	Change in Persian version of Swallowing Disturbance Questionnaire (SDQ) over the period of the study. The SDQ is a 15 item scale. The total scores range is 0-45. A score higher 11 indicates swallowing difficulty.	Change from Baseline in SDQ at 4 weeks and 3 month follow up
Dysphagia handicap index (DHI)	Change in Persian version of Dysphagia handicap index (DHI) over the period of the study. The DHI is one of the instruments used for measuring a dysphagic patient's self-assessment. it reflects the patient's quality of life. DHI is a 25 item scale. The total scores range is 0-100. A higher score indicates a greater impact of swallowing disorders on quality of life	Change from Baseline in DHI at 4 weeks and 3 month follow up
northwest dysphagia patient check sheet (NDPCS)	Change in Persian version of northwest dysphagia patient check sheet (NPCS) scores over the period of the study. The NDPCS has five and 28 items. Each item is scored as safe or unsafe. The total score is calculated from the total number of unsafe items. The more unsafe observations indicates swallowing difficulty.	Change from Baseline in NDPCS at 4 weeks and 3 month follow up
Geriatric Depressive Scale (GDS)	Change in Persian version of Geriatric Depressive Scale (GDS) scores over the period of the study. GDS is a 15 item scale. Each item is scored as yes or no. More than 5 signs indicate the possibility of depression and more than 10 signs of depression indicate definite depression.	Change from Baseline in GDS at 4 weeks and 3 month follow up
quality of life (QoL)	Change in SF-36 questionnaire over the period of the study. Quality of life will be measured using SF-36 questionnaire. SF-36 is a 36 item scale. The total scores range is 0-100. A higher score indicates a better quality of life.	Change from Baseline in QOL at 4 weeks and 3 month follow up
jitter	Change in jitter over the period of the study, which will be based on analysis of acoustic recordings. jitter will be measured in produce the vowel /a/. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals.	Change from Baseline in jitter at 4 weeks and 3 month follow up
shimmer	Change in shimmer over the period of the study, which will be based on analysis of acoustic recordings. shimmer will be measured in produce the vowel /a/. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals.	Change from Baseline in shimmer at 4 weeks and 3 month follow up
highest and lowest frequency	Change in highest and lowest frequency over the period of the study, which will be based on analysis of acoustic recordings. highest and lowest frequency will be measured by asking the subject to produce the vowel /a/ as high and low frequency as they can produces. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals.	Change from highest and lowest frequency at 4 weeks and 3 month follow up

Collaborators and Investigators

• Sponsor: Iran University of Medical Sciences
• Investigators: Study Director: Reyhaneh Mohammadi, Iran university of medical science

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2021
• Primary Completion (Actual): January 7, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 10, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Otorhinolaryngologic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Language Disorders; Communication Disorders; Laryngeal Diseases; Disease; Parkinson Disease; Speech Disorders; Voice Disorders
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No