Investigation the effect of skin mechanoreceptor stimulation on rest and kinetic parkinsonian tremor
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) 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.
Intervention groups
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
Main outcome variables
Tremor severity based on UPDRS criteria(The Unified Parkinson's Disease Rating Scale)
maximum of acceleration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210504051178N1
Registration date:2022-02-05, 1400/11/16
Registration timing:registered_while_recruiting
Last update:2022-02-05, 1400/11/16
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 rest and kinetic parkinsonian tremor
Public title
Effect of mechanichal stimulation on parkinsonian 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
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
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
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 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.
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