Comparing the effectiveness of using virtual reality with a control group without using virtual reality on suppressing hand tremors in Parkinson's disease.
Determining the effectiveness of virtual reality compared to not using of virtual reality on hand tremors suppression in Parkinson's disease
Design
The randomized clinical trial, parallel groups, 15 patients will be enrolled in each arms of the study. Randomization will be conduct using RAND function in EXCEL.
Settings and conduct
Parkinson's patients referring to Omid Clinic in Hamedan will be included in the study. Blinding will not be performed.
Participants/Inclusion and exclusion criteria
Inclusion criterion: Parkinson's patients who have hand tremors.
Non-inclusion criteria: Old age or any problem that causes the inability to use virtual reality technology
Intervention groups
Patients in the intervention group watch some images with a headset in cyberspace and perform hand movements. Control group will only watch some images without using headset.
Main outcome variables
Hand Tremors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220413054525N1
Registration date:2022-07-17, 1401/04/26
Registration timing:prospective
Last update:2022-07-17, 1401/04/26
Update count:0
Registration date
2022-07-17, 1401/04/26
Registrant information
Name
Seyedeh Marzieh Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 1964
Email address
ma.hoseini2522@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of using virtual reality with a control group without using virtual reality on suppressing hand tremors in Parkinson's disease.
Public title
The effect of virtual reality in Parkinson's tremor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parkinson's patients who affected by hand tremor
Exclusion criteria:
Elderly people who is not able to do Intervention
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method will be used.
A randomized list will be generated by RAND function in EXCEL. Patients will be allocated to
intervention or control group according to the generated
list.
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 Hamadan University of Medical Sciences
Street address
Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838778
Approval date
2022-03-05, 1400/12/14
Ethics committee reference number
IR.UMSHA.REC.1400.954
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
hand tremors in Parkinson’s disease
Timepoint
hand tremors will be measured at the beginning of the study (before the intervention) and after 10 training sessions during 5 weeks.
Method of measurement
IMU sensor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group watch some images with a headset in cyberspace and perform hand movements.
Category
Treatment - Devices
2
Description
Control group: Virtual reality technology will not be used for the control group, and patients in this group will watch images without wearing glasses.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid clinic
Full name of responsible person
Shahir Mazaheri
Street address
Sabad-bafan Ave,
City
Hamedan
Province
Hamadan
Postal code
6517656878
Phone
+98 918 111 6858
Email
mazaheri@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6571838678
Phone
+98 918 107 9443
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seyedeh Marzieh Hosseini
Position
Postdoctoral researcher
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3831 6215
Email
ma.hoseini2522@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyedeh Marzieh Hosseini
Position
Postdoctoral researcher
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3831 6215
Email
ma.hoseini2522@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyedeh Marzieh Hosseini
Position
Postdoctoral researcher
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3831 6215
Email
ma.hoseini2522@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available