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

Primary Purpose

Speech Disorders, Voice Disorders, Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
combined speech and music therapy
speech therapy
music therapy
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Speech Disorders

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Iran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

combined speech and music therapy

speech therapy

music therapy

Arm Description

the telerehabilitation intervention that include both speech therapy and music therapy at the same time

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

music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 30, 2021
Last Updated
March 31, 2023
Sponsor
Iran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04966689
Brief Title
The Effect of Combined Speech and Music-therapy on the Speech Characteristics of People With Parkinson's Disease (PD)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2021 (Actual)
Primary Completion Date
January 7, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Disorders, Voice Disorders, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
combined speech and music therapy
Arm Type
Experimental
Arm Description
the telerehabilitation intervention that include both speech therapy and music therapy at the same time
Arm Title
speech therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
music therapy
Arm Type
Active Comparator
Arm Description
music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation
Intervention Type
Behavioral
Intervention Name(s)
combined speech and music therapy
Intervention Description
he telerehabilitation intervention that include both speech therapy and music therapy at the same time
Intervention Type
Behavioral
Intervention Name(s)
speech therapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
music therapy
Intervention Description
music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation
Primary Outcome Measure Information:
Title
loudness
Description
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.
Time Frame
Change from Baseline in loudness at 4 weeks and 3 month follow up
Secondary Outcome Measure Information:
Title
Voice Handicap Index (VHI)
Description
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.
Time Frame
Change from Baseline in VHI at 4 weeks and 3 month follow up
Title
maximum phonation time (MPT)
Description
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.
Time Frame
Change from Baseline in MPT at 4 weeks and 3 month follow up
Title
Speech Intelligibility
Description
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.
Time Frame
Change from Baseline in Speech Intelligibility at 4 weeks and 3 month follow up
Title
Swallowing Disturbance Questionnaire (SDQ)
Description
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.
Time Frame
Change from Baseline in SDQ at 4 weeks and 3 month follow up
Title
Dysphagia handicap index (DHI)
Description
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
Time Frame
Change from Baseline in DHI at 4 weeks and 3 month follow up
Title
northwest dysphagia patient check sheet (NDPCS)
Description
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.
Time Frame
Change from Baseline in NDPCS at 4 weeks and 3 month follow up
Title
Geriatric Depressive Scale (GDS)
Description
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.
Time Frame
Change from Baseline in GDS at 4 weeks and 3 month follow up
Title
quality of life (QoL)
Description
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.
Time Frame
Change from Baseline in QOL at 4 weeks and 3 month follow up
Title
jitter
Description
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.
Time Frame
Change from Baseline in jitter at 4 weeks and 3 month follow up
Title
shimmer
Description
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.
Time Frame
Change from Baseline in shimmer at 4 weeks and 3 month follow up
Title
highest and lowest frequency
Description
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.
Time Frame
Change from highest and lowest frequency at 4 weeks and 3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reyhaneh Mohammadi
Organizational Affiliation
Iran university of medical science
Official's Role
Study Director
Facility Information:
Facility Name
Iran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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