To evaluate the efficacy of 18 sessions of arm and forearm eccentric training on hand tremor in patients with Parkinson's disease
Design
parallel clinical trial with control group and random allocation of the patients to control and intervention group and blinded analysis of the outcomes.
Settings and conduct
This study will recruit patients with Parkinson's disease who visit neurology clinic in Firoozgar and Rasoul Akram hospitals in Tehran. Eccentric exercise sessions will be completed in occupational therapy part of Friroozgar hospital with occupational therapist assistance and surveillance. Tremor will be quantified by Seismometer application (validated by laboratory accelerometers) and Sony experia Z1 smartphone. Tremor data will be extracted as excell file and analyzed by MatLab software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Parkinson's disease whose diagnosis has been confirmed by neurologist Visible hand tremor. Being capable of performing upper limb eccentric exercise
Exclusion criteria: Diagnosis of Parkinson like diseases with hand tremor
Cardiovascular, neurological, orthopedic and psychological disabilities in performing eccentric exercise of upper limbs
Concurrent other movement abnormalities in upper limbs like chorea or spasticity
Intervention groups
patients in intervention group will go under 18 sessions of bilateral arm and forearm eccentric training with moderate intensity and with assistance of occupational therapist. sessions will be three days a week in 6 weeks.
patients in control group will not receive any intervention. they will be asked to keep their usual level of physical activity for 6 weeks.
Main outcome variables
Resting hand tremor ; postural hand tremor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180221038819N1
Registration date:2018-04-21, 1397/02/01
Registration timing:registered_while_recruiting
Last update:2018-04-21, 1397/02/01
Update count:0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
Mona Kadkhodaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 1021
Email address
mk.sbmu@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of eccentric training on hand tremor in parkinsonian patients with control group
Public title
The effect of eccentric training on hand tremor in parkinson's disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Parkinson's disease whose diagnosis has been confirmed by neurologist
Visible hand tremor
Being capable of upper limb eccentric exercise
Exclusion criteria:
Diagnosis of Parkinson like diseases capable of manifesting with hand tremor
Cardiovascular, neurological, orthopedic and psychological disabilities in operating eccentric exercise of upper limbs
Concurrent other movement symptoms in upper limbs like chorea or spasticity
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Random block. Subjects are assigned to blocks, based on stage of disease.(Hoehn and Yahr staging) Then, within each block, subjects are randomly assigned to intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Main building, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
IR.IUMS.FMD.REC 1395.28471
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
Resting hand tremor amplitude
Timepoint
before intervention and after 18 sessions of eccentric exercise
Method of measurement
Seismometer 6th application in Sony experia Z1 smartphone
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: this group will undergo 18 sessions of eccentric exercise with moderate intensity of forearm flexors and extensors and arm flexors group of muscles in 30-40 minutes in each session. Exercise sessions will be assisted by trained occupational therapist as 3 sessions in week. Concentric phase of each exercise will be performed by occupational therapist and only the eccentric phase will be done by patient. As the sessions progress, according to patient ability, the weights will be heavier with maintaining moderate intensity.
Category
Rehabilitation
2
Description
Control group: This group will receive no intervention. Control group will be asked to maintain their usual level of activity for six weeks.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Hassan Amiri
Street address
Niayesh Ave., Sattar khan Town.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2190
Email
hrmc@iums.ac.ir
Web page address
http://hrmc.iums.ac.ir
2
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Farhad Zamani
Street address
Beh afarin Ave., Karimkhan Ave,. Valieasr Square.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Fax
+98 21 8894 2622
Email
h_firoozgar@yahoo.com
Web page address
http://firoozgar.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malakouti
Street address
By Milad Tower, Hemmat Highway,
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://res.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
Mona Kadkhodaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Parvaneh Dead end, Chizari Ave., Ehteshamieh Town,
City
Tehran
Province
Tehran
Postal code
1945616571
Phone
+98 21 2259 3044
Email
mk.sbmu@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Kadkhodaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Parvaneh Dead end, Chizari Ave., Ehteshamieh Town,
City
Tehran
Province
Tehran
Postal code
1945616571
Phone
+98 21 2259 3044
Email
mk.sbmu@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Kadkhodaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Parvaneh Dead end, Chizari Ave., Ehteshamieh Town,
City
Tehran
Province
Tehran
Postal code
1945616571
Phone
+98 21 2259 3044
Email
mk.sbmu@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
Almost all deidentified data of participants like demographic data (age, sex,...) , disease related data (stage, type,...) and finally samples of unanalysed data adapted from participants tremor; can be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Deidentified IPD and other documents will only be available foe people working in academic institutes.
Under which criteria data/document could be used
Any scientific analysis on shared data is allowed but the main researcher must be informed about the results obtained from data analysis before publication. After sending requesting email to main researcher, giving information about the reason of request, being assured about scientific position of requester in universities or scientific institutes and passing 6 months from publication; data will be shared.
From where data/document is obtainable
main researcher : Mona Kadkhodaie
sending request via email: mk.sbmu@yahoo.com
What processes are involved for a request to access data/document
after receiving data sharing request, the request will be checked by all researchers of the article and if the reasons of requesting are convincing, data will be send via email in maximum 2 weeks.