Protocol summary

Study aim
the effect of a combined speech and music therapy on speech function in Parkinson's disease through telerehabilitation. Our hypothesis is that patients in the combined therapy group will have more improvement in the outcome measure than speech therapy group and music therapy group after treatment and 1-month follow-up .
Design
A clinical trial with three groups, with parallel groups, one-way blind, randomized, on 33 patients, used the Rand function of Excel software for randomization.
Settings and conduct
Individuals selected from Parkinson's patients patients referred to speech therapy clinics, hospitals and clinics in Tehran. The method of study will be explained to them in face to face session . If they were willing to cooperate, The consent form is signed by them and the biography is taken from the people. These people are then evaluated. In this study, evaluator and patients will be blinded during the entire process.
Participants/Inclusion and exclusion criteria
idiopathic Parkinson's patients
Intervention groups
The present study includes three groups of therapy: speech therapy,music therapy and combined speech and music therapy .The Speech Therapy Group will receive common and routine speech exercises, including breathing exercises, loudness, pitch, and intelligibility. The music exercises will be designed based on the music therapy protocols of previous studies, which consists of five parts: Section 1: Motor exercises; Section 2: Breathing Exercises; Section 3: vocal Exercises; Section 4: Singing Exercises; Section 5: Final Conversation and Homework.The combination therapy group also receives both speech therapy and music therapy at the same time.
Main outcome variables
voice parameters ( loudness, f0 , The highest and lowest frequency they can produce, jitter and shimmer),

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210622051667N1
Registration date: 2021-06-30, 1400/04/09
Registration timing: prospective

Last update: 2021-06-30, 1400/04/09
Update count: 0
Registration date
2021-06-30, 1400/04/09
Registrant information
Name
Zeinab Mohseny
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
zeynab_mohseny@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-03, 1400/04/12
Expected recruitment end date
2021-08-03, 1400/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of The effect of speech therapy , music-therapy and combined speech and music therapy on the vocal characteristics of people with Parkinson's disease by using telerehabilitation
Public title
The effect of combined speech and music-therapy on the vocal characteristics of people with Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with idiopathic Parkinson's disease (IPD) Patients in terms of disease severity in stages 1-3 based on the Hoehn & Yahr test Patient or family complaints about individual speech Ability to use r telerehabilitation and have a smartphone Adequate vision and hearing Use of drug therapy No history of stroke, head injury, brain surgery and laryngeal diseases such as vocal cord nodules, etc. No other neurological disorders other than idiopathic Parkinson's disease Do not use treatments other than medication (such as deep brain stimulation surgery (DBS))
Exclusion criteria:
If a patient develops a stroke or other neurological complication during treatment, they are excluded from the treatment plan. • Lack of cooperation
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
First, using SPSS software for numbers from 1 to 33, we produce three groups with 11 numbers from zero, one or two. By balloting, the speech therapy group was assigned number zero, the combination therapy group number one and the music therapy group number two.To hide the created list, all the mentioned steps are done by someone who does not do the research. Then, each of the groups of zero, one and two are placed inside the closed envelopes and the envelopes are numbered on them so as not to disturb them. After the patients are admitted to the study according to the inclusion and exclusion criteria, the envelopes are opened in order to determine which group each patient will be in.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the person performing the assessments did not know which group each patient was in. Finally, the data obtained from the study are provided for analysis to a person who is unaware of the therapy groups .
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Department of Speech Therapy, school of Rehabilitation science, Iran University of Medical Sciences, Madadakaran St, ShahNazari Ave, Mother square, Mirdamad Ave, Tehran.
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2021-02-07, 1399/11/19
Ethics committee reference number
IR.IUMS.REC.1400.044

Health conditions studied

1

Description of health condition studied
Parkinson’s Disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
voice parameters ( loudness, fundamental frequency , The highest and lowest frequency they can produce, jitter and shimmer)
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
praat software

Secondary outcomes

1

Description
Voice Handicap Index
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
Persian version of Voice Handicap Index

2

Description
maximum phonation time
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
The maximum amount of time a person can sustain phonation of "ah" is timed

3

Description
Speech Intelligibility
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
seven scale of Fodala rankings

4

Description
Swallowing Disturbance Questionnaire
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
Persian version of Swallowing Disturbance Questionnaire

5

Description
Dysphagia handicap index
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
Persian version of Dysphagia handicap index

6

Description
northwest dysphagia patient check sheet
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
Persian version of northwest dysphagia patient check sheet

7

Description
quality of life
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
Persian version of quality of life test 36 questions

8

Description
Geriatric Depressive Scale
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
Persian version of Geriatric Depressive Scale

Intervention groups

1

Description
Intervention group: Combined speech and music therapy using telerehabilitation.. This group receive speech and music exercises at the same time in each treatment session. Speech exercises includes routine breathing exercises, loudness, pitch and speech Intelligibility, and music exercises includes posture correction, breathing exercises, warm-up exercises, voice exercises and singing exercises.The duration of the intervention is 4 weeks and the exercises are performed three times a week by a speech and language pathologist and a music and song specialist via video call on WhatsApp.
Category
Rehabilitation

2

Description
control group 1: speech therapy. this Group performs common and routine speech exercises, including breathing exercises, loudness, pitch, and intelligibility, which are the authority to use LSVT therapy and voice exercises. The duration of the intervention is 4 weeks and the exercises are performed three times a week by a speech and language pathologist via video call on WhatsApp.
Category
Rehabilitation

3

Description
Control group 2: music therapy. The music exercises used in this study for music therapy group are designed based on the music therapy protocols of previous studies and It consists of five parts: Part 1: Motor exercises; Section 2: Breathing Exercises; Section 3: vocal Exercises; Section 4: Singing Exercises; Section 5: Final Conversation and Homework. The duration of the intervention is 4 weeks and the exercises are performed three times a week by a speech and language pathologist via video call on WhatsApp.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
school of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Dr. Nahid Jalilavand
Street address
Department of Speech Therapy, school of Rehabilitation science, Iran University of Medical Sciences, Madadakaran St, ShahNazari Ave, Mother square, Mirdamad Ave, Tehran.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
rehab@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malakouti. vice chancellor for research
Street address
Vice chancellor for research and technology, 5 the floor, the Central Building, Iran University of Medical Sciences, between Shahid Chamran and Sheikh Fazlollah Nouri Highways Hemmat Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reyhaneh Mohammadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, school of Rehabilitation science, Iran University of Medical Sciences, Madadakaran St, ShahNazari Ave, Mother square, Tehran.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
mohamadi.re88@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeinab Mohseni
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, school of Rehabilitation science, Iran University of Medical Sciences, Madadakaran St, ShahNazari Ave, Mother square, Tehran.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
zeynab_mohsny@yshoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeynab Mohseny
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, school of Rehabilitation science, Iran University of Medical Sciences, Madadakaran St, ShahNazari Ave, Mother square, Tehran.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
zeynab_mohseny@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data or results of the present study will be presentation in an article or some articles that will be published, also will be available through correspondence with the corresponding author.
When the data will become available and for how long
After completing the present study and publishing the resulting article or articles.
To whom data/document is available
All researchers in the field of the present study
Under which criteria data/document could be used
With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the Iran University of Medical Sciences.
From where data/document is obtainable
The corresponding author of the article or articles derived from the study
What processes are involved for a request to access data/document
Written request from the author responsible fore the the present review after the publication of the article or articles
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