History
# Registration date Revision Id
2 2023-03-19, 1401/12/28 259523
1 2022-02-05, 1400/11/16 215626
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  • Protocol summary

    Investigation the effect of skin mechanoreceptor stimulation on rest and kinetic parkinsonian tremor
    Investigation the effect of skin mechanoreceptor stimulation on rest tremor of parkinsonian patients and kinetic tremor of Essential tremor patients
    بررسی تاثیر تحریک مکانیکی مکانورسپتورهای پوست بر ترمور استراحتی و کینتیک در بیماران پارکینسونی
    بررسی تاثیر تحریک مکانیکی مکانورسپتورهای پوست بر ترمور استراحتی بیماران پارکینسونی و ترمور کینتیک در بیماران اسنشیل ترمور
    Parkinson' patients will be study for 10 sessions (at neurologist' office). Two intervention groups and one control group reevaluate first session and final session and one month later by neurology resident ( based on UPDRS criteria, The Unified Parkinson's Disease Rating Scale) and these session acceleration of tremor will be recorded by biomedical PHD student. The data will be extracted with unknown identification for analysis.
    Parkinson' patients will be study for 10 sessions (at neurologist' office). Two intervention groups and one control group reevaluate first session and final session and one month later by neurology resident ( based on UPDRS criteria, The Unified Parkinson's Disease Rating Scale) for Parkinsonian patient and TETRAS scoring for Essential tremor patients and these session acceleration of tremor will be recorded by biomedical PHD student. The data will be extracted with unknown identification for analysis.
    بیماران پارکینسون به مدت 10 جلسه تحت مداخله قرار میگیرد (در محل مطب پزشک متخصص مغز و اعصاب). قبل شروع مداخله و جلسه آخر یکماه بعد از نظر معیار سوم UPDRS (The Unified Parkinson's Disease Rating Scale) توسط رزیدنت مغز و اعصاب معاینه انجام میشود. توسط شتاب شنج فاکتور های مربوط به لرزش قبل مداخله و جلسه آخر و یک ماه بعد ثبت میشود و اطلاعات به صورت هویت نامشخص در اختیار آنالیز کننده قرار میگیرد.
    بیماران پارکینسون و بیماران با اسنشیل ترمور به مدت 10 جلسه تحت مداخله قرار میگیرد (در محل مطب پزشک متخصص مغز و اعصاب). قبل شروع مداخله و جلسه آخر یکماه بعد بیماران پارکینسونی از نظر معیار سوم UPDRS (The Unified Parkinson's Disease Rating Scale) و بیماران با اسنشیل ترمور با معیار بالینی TETRAS توسط رزیدنت مغز و اعصاب معاینه انجام میشود. توسط شتاب شنج فاکتور های مربوط به لرزش قبل مداخله و جلسه آخر و یک ماه بعد ثبت میشود و اطلاعات به صورت هویت نامشخص در اختیار آنالیز کننده قرار میگیرد.
    Parkinson patients ( base on MDS criteria) that have rest tremor and collaboration ability , don't use DBS (deep brain stimulation) or Apomorphine pump.
    Parkinson patients ( base on MDS criteria) that have rest tremor and collaboration ability , don't use DBS (deep brain stimulation) or Apomorphine pump. Essential tremor ( kinetic tremor of hand)
    بیماران پارکینسونی( بر اساس معیار MDS ) که ترمور استراحتی و توانایی همکاری داشته باشند و از روش های درمانی پمپ آپومورفین و (deep brain stimulation) DBS استفاده نکرده باشد.
    بیماران پارکینسونی( بر اساس معیار MDS ) که ترمور استراحتی و توانایی همکاری داشته باشند و از روش های درمانی پمپ آپومورفین و (deep brain stimulation) DBS استفاده نکرده باشد. بیماران اسنشیل ترمور ( با ترمور کینتیک دست)
    First group is intervened by mechanical stimulation while the hand is rest position and second group while is drawing a figure. We put equipment just on the hand with out stimulation in control group
    First group parkinsonian patients is intervened by mechanical stimulation while the hand is rest position and second group , Essential tremor patients, while is drawing a figure. We put equipment just on the hand with out stimulation in control group
    گروه اول در حالی که دست در حالت استراحت است تحریک مکانیکی اعمال میشود و گروه دوم در حالت رسم شکل تحریک داده می شود و گروه کنترل فقط وسیله روی دست قرار میگیرد .
    گروه اول بیماران پارکینسونی در حالی که دست در حالت استراحت است تحریک مکانیکی اعمال میشود و گروه دوم بیماران با اسنشیل ترمور که در حالت رسم شکل تحریک داده می شود و گروه کنترل فقط وسیله روی دست قرار میگیرد .
    Tremor severity based on UPDRS criteria(The Unified Parkinson's Disease Rating Scale) maximum of acceleration
    Tremor severity based on UPDRS criteria(The Unified Parkinson's Disease Rating Scale) for parkinsonian patients and TETRAS scoring for Essential tremor patients maximum of acceleration
    شدت ترمور بر اساس معیارهای UDPRS (The Unified Parkinson's Disease Rating Scale) حداکثر شتاب ثبت شده
    شدت ترمور بر اساس معیارهای UDPRS (The Unified Parkinson's Disease Rating Scale) برای بیماران پارکینسونی و معیار TETRAS برای بیماران با ترمور اسنشیل حداکثر شتاب ثبت شده
  • General information

    empty
    for assessment of skin mechanoreceptors stimulationon on kinetic tremor, one group of Essential tremor is added.
    empty
    جهت ارزیابی تاثیر تحریک مکانورسپتورهای پوست بر ترمور کینتیک دربیماران مبتلا به ترمور اسانشیل، یک گروه از بیماران ترمور اسنشیل اضافه می شود.
    Effect of mechanichal stimulation on parkinsonian tremor
    Effect of mechanichal stimulation on parkinsonian tremor and Essential tremor
    بررسي اثر تحريک مکانيکي بر ترمور بيماران پارکينسوني
    بررسي اثر تحريک مکانيکي بر ترمور بيماران پارکينسوني و اسنشیل ترمور
    Effect of skin mechanoreceptors stimulation on rest and kinetic parkinsonian tremor
    Effect of skin mechanoreceptors stimulation on resting tremor in parkinsonian patients and kinetic tremor in patients with essential tremor.
    تاثير تحريک مکانيکي مکانورسپتورهاي پوست بر ترمور استراحتي و کينتيک در بيماران پارکينسوني
    تاثیر تحریک مکانیکی مکانورسپتورهای پوست بر ترمور استراحتی بیماران پارکینسونی وترمور کینتیک دربیماران مبتلا به ترمور اسانشیل
    Parkinson disease is diagnosed based on MDS criteria
    At least one hand has rest tremor
    40 years old at the onset of disease.
    All patients will fill out a consent form
    Parkinson disease is diagnosed based on MDS criteria
    At least one hand has rest tremor
    40 years old at the onset of disease.
    All patients will fill out a consent form
    Kinetic tremor in hand ( Essential tremor)
    بيماري پارکينسون بر اساس معيارهاي MDS تشخيص داده شد
    ترمور استراحتي حداقل در يک دست وجود دارد
    در شروع بيماري سن بالاي 40 سال داشته باشد
    رضايت براي شرکت در مطالعه داشته باشد
    بيماري پارکينسون بر اساس معيارهاي MDS تشخيص داده شد
    ترمور استراحتي حداقل در يک دست وجود دارد
    در شروع بيماري سن بالاي 40 سال داشته باشد
    رضايت براي شرکت در مطالعه داشته باشد
    کینتیک ترمور دست ( اسنشیل ترمور)
  • Health conditions studied

    #1
    empty
    G25.0
    empty
    Essential tremor
    empty
    Essential tremor
    empty
    ترمور اسنشیل
  • Primary outcomes

    #1
    part 3 of UDPRS criteria (The Unified Parkinson's Disease Rating Scale) and accelerometer
    part 3 of UDPRS criteria (The Unified Parkinson's Disease Rating Scale) and accelerometer, TETRAS scoring for Essential tremor
    قسمت سوم معیار های (The Unified Parkinson's Disease Rating Scale)UDPRS و شتاب سنج
    قسمت سوم معیار های (The Unified Parkinson's Disease Rating Scale)UDPRS و شتاب سنج معیار بالینی TETRAS برای بیماران اسنشیل ترمور
  • Intervention groups

    #1
    Intervention group 2: 5 parkinson' patients will be intervened on the hand while it is drawing a figure , consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on UDPRS criteria and accelerometer at first and final session and one month later.
    Intervention group 2: 5 Essential tremor' patients will be intervened on the hand while it is drawing a figure , consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on TETRAS criteria and accelerometer at first and final session and one month later.
    گروه مداخله2: دست 5 بیمار مبتلا به پارکینسون در حالت رسم شکل مداخله اعمال می شود. همه مداخلات در 10 جلسه متوالی (روزانه یک جلسه) به مدت نیم ساعت انجام خواهند شد.شدت ترمور در جلسات اول،پایانی و یک ماه بعد بر اساس کرایتریای UDPRS و شتاب سنج مورد ارزیابی قرار میگیرد.
    گروه مداخله2: دست 5 بیمار مبتلا به اسنشیل ترمور در حالت رسم شکل مداخله اعمال می شود. همه مداخلات در 10 جلسه متوالی (روزانه یک جلسه) به مدت نیم ساعت انجام خواهند شد.شدت ترمور در جلسات اول،پایانی و یک ماه بعد بر اساس کرایتریای TETRAS و شتاب سنج مورد ارزیابی قرار میگیرد.
  • Recruitment centers

    #1
    Name of recruitment center - English: Ali Shoeibi' office (MD)
    Name of recruitment center - Persian: مطب دکتر علی شعیبی
    Full name of responsible person - English: Ali Shoeibi
    Full name of responsible person - Persian: علی شعیبی
    Street address - English: No 5, Daneshgah Ave, Mashhad city
    Street address - Persian: خیابان دانشگاه، دانشگاه 18، ساختمان پزشکان سپید، پلاک 5 ، واحد 10
    City - English: mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 0859306968
    Phone: +98 51 3858 6858
    Fax:
    Email: shoeibia@mums.ac.ir
    Web page address:
    Name of recruitment center - English: Ali Shoeibi' office (MD)
    Name of recruitment center - Persian: مطب دکتر علی شعیبی
    Full name of responsible person - English: Ali Shoeibi
    Full name of responsible person - Persian: علی شعیبی
    Street address - English: No 5, Daneshgah Ave, Mashhad city
    Street address - Persian: خیابان دانشگاه، دانشگاه 18، ساختمان پزشکان سپید، پلاک 5 ، واحد 10
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 0859306968
    Phone: +98 51 3858 6858
    Fax:
    Email: shoeibia@mums.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Iran National Science Foundation
    Name of organization / entity - Persian: صندوق حمایت از پژوهشگران و فناوران کشور
    Full name of responsible person - English: hamidreza Kobravi
    Full name of responsible person - Persian: حمیدرضا کبروی
    Street address - English: Yousefi Ave, Emamieh Blvd, Islamic Azad University of Masshad
    Street address - Persian: مشهد، قاسم آباد بلوار امامیه خیابان استاد یوسفی دانشکده فنی مهندسی دانشگاه آزاد اسلامی مشهد
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9187147578
    Phone: +98 51 3662 9467
    Fax:
    Email: hkobravi@mshdiau.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Iran National Science Foundation
    Name of organization / entity - Persian: صندوق حمایت از پژوهشگران و فناوران کشور
    Full name of responsible person - English: Hamidreza Kobravi
    Full name of responsible person - Persian: حمیدرضا کبروی
    Street address - English: Yousefi Ave, Emamieh Blvd, Islamic Azad University of Masshad
    Street address - Persian: مشهد، قاسم آباد بلوار امامیه خیابان استاد یوسفی دانشکده فنی مهندسی دانشگاه آزاد اسلامی مشهد
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9187147578
    Phone: +98 51 3662 9467
    Fax:
    Email: hkobravi@mshdiau.ac.ir
    Web page address:

Protocol summary

Study aim
Investigation the effect of skin mechanoreceptor stimulation on rest tremor of parkinsonian patients and kinetic tremor of Essential tremor patients
Design
Clinical trial with three parallel, groups and blinded intervention, outcome assessment and analysis, designed of 15 patients.
Settings and conduct
Parkinson' patients will be study for 10 sessions (at neurologist' office). Two intervention groups and one control group reevaluate first session and final session and one month later by neurology resident ( based on UPDRS criteria, The Unified Parkinson's Disease Rating Scale) for Parkinsonian patient and TETRAS scoring for Essential tremor patients and these session acceleration of tremor will be recorded by biomedical PHD student. The data will be extracted with unknown identification for analysis.
Participants/Inclusion and exclusion criteria
Parkinson patients ( base on MDS criteria) that have rest tremor and collaboration ability , don't use DBS (deep brain stimulation) or Apomorphine pump. Essential tremor ( kinetic tremor of hand)
Intervention groups
First group parkinsonian patients is intervened by mechanical stimulation while the hand is rest position and second group , Essential tremor patients, while is drawing a figure. We put equipment just on the hand with out stimulation in control group
Main outcome variables
Tremor severity based on UPDRS criteria(The Unified Parkinson's Disease Rating Scale) for parkinsonian patients and TETRAS scoring for Essential tremor patients maximum of acceleration

General information

Reason for update
for assessment of skin mechanoreceptors stimulationon on kinetic tremor, one group of Essential tremor is added.
Acronym
IRCT registration information
IRCT registration number: IRCT20210504051178N1
Registration date: 2022-02-05, 1400/11/16
Registration timing: registered_while_recruiting

Last update: 2023-03-19, 1401/12/28
Update count: 1
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Seyede Pourandokht Mousavian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 3625
Email address
mousavianp981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-05, 1400/11/16
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of skin mechanoreceptors stimulation on resting tremor in parkinsonian patients and kinetic tremor in patients with essential tremor.
Public title
Effect of mechanichal stimulation on parkinsonian tremor and Essential tremor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parkinson disease is diagnosed based on MDS criteria At least one hand has rest tremor 40 years old at the onset of disease. All patients will fill out a consent form Kinetic tremor in hand ( Essential tremor)
Exclusion criteria:
Severe disabilities Neuropathy MMSE score less than 26 Mood disorders and anxiety treatment with DBS and apomorphine pump Dose of drugs changed one month before Accompany of disorders or drugs that exaggerated tremor
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Parkinson 'patients are selected , examined and grouped randomized by neurology resident. Intervention of each group is doing by biomedical engineering phd student. Neurology resident does examination of groups and gathers information but intervention of groups is unknown. Analysis of data is doing by phd student while the identity of data is not evident.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of mashhad university of medical sciences
Street address
No 11. Goldis Ave, Boronsi Blvd, mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9179833367
Approval date
2021-01-19, 1399/10/30
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.775

Health conditions studied

1

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

2

Description of health condition studied
Essential tremor
ICD-10 code
G25.0
ICD-10 code description
Essential tremor

Primary outcomes

1

Description
tremor severity
Timepoint
before beginning of intervention ( at the first of sampling and start of intervention), final session, after one month
Method of measurement
part 3 of UDPRS criteria (The Unified Parkinson's Disease Rating Scale) and accelerometer, TETRAS scoring for Essential tremor

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: 5 parkinson' patients will be intervened on the hand while it is at a rest position , consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on UDPRS criteria and accelerometer at first and final session and one month later.
Category
Treatment - Devices

2

Description
Intervention group 2: 5 Essential tremor' patients will be intervened on the hand while it is drawing a figure , consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on TETRAS criteria and accelerometer at first and final session and one month later.
Category
Treatment - Devices

3

Description
Control group: We put equipment on the hand of 5 parkinson' patients at a rest position, consecutive 10 session for half an hour duration is designed. Tremor severity will be evaluate based on UDPRS criteria and accelerometer at first and final session and one month later.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Shoeibi' office (MD)
Full name of responsible person
Ali Shoeibi
Street address
No 5, Daneshgah Ave, Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
0859306968
Phone
+98 51 3858 6858
Email
shoeibia@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Hamidreza Kobravi
Street address
Yousefi Ave, Emamieh Blvd, Islamic Azad University of Masshad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3662 9467
Email
hkobravi@mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Shoeibi
Position
Assistant Professor of neurology
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3840 0000
Email
shoeibia@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Shoeibi
Position
Assistant Professor of neurology
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3840 0000
Email
shoeibia@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyede Pourandokht Mousavian
Position
Neurology resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3840 0000
Email
medmoosavian@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
some part of data can be communalized
When the data will become available and for how long
6 months after publication
To whom data/document is available
researchers of scientific institution and university
Under which criteria data/document could be used
different analysis for researchers
From where data/document is obtainable
Ali Shoeibi MD, Ahmad Abad Blvd, Qaem hospital, shoeibia@mums.ac.ir
What processes are involved for a request to access data/document
emailing, duration:3 weeks
Comments
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