Protocol summary
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Study aim
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Investigation the effect of skin mechanoreceptor stimulation on rest tremor of parkinsonian patients and kinetic tremor of Essential tremor patients
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Design
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Clinical trial with three parallel, groups and blinded intervention, outcome assessment and analysis, designed of 15 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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)
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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for assessment of skin mechanoreceptors stimulationon on kinetic tremor, one group of Essential tremor is added.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-02-05, 1400/11/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-02-05, 1400/11/16
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Expected recruitment end date
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2022-05-20, 1401/02/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of skin mechanoreceptors stimulation on resting tremor in parkinsonian patients and kinetic tremor in patients with essential tremor.
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Public title
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Effect of mechanichal stimulation on parkinsonian tremor and Essential tremor
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
15
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-19, 1399/10/30
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1399.775
Health conditions studied
1
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Description of health condition studied
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Parkinson's disease
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ICD-10 code
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G20
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ICD-10 code description
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Parkinson's disease
2
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Description of health condition studied
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Essential tremor
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ICD-10 code
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G25.0
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ICD-10 code description
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Essential tremor
Primary outcomes
1
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Description
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tremor severity
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Timepoint
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before beginning of intervention ( at the first of sampling and start of intervention), final session, after one month
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Method of measurement
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part 3 of UDPRS criteria (The Unified Parkinson's Disease Rating Scale) and accelerometer, TETRAS scoring for Essential tremor
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Treatment - Devices
3
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran National Science Foundation
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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some part of data can be communalized
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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researchers of scientific institution and university
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Under which criteria data/document could be used
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different analysis for researchers
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From where data/document is obtainable
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Ali Shoeibi MD, Ahmad Abad Blvd, Qaem hospital, shoeibia@mums.ac.ir
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What processes are involved for a request to access data/document
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emailing, duration:3 weeks
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Comments
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