Determining the minimum clinically important difference (MCID) for four balance assessment tools in individuals with Parkinson’s disease.
Design
Interventions will be carried out in the form of balance exercises over eight weeks. Balanced physical activity on different surfaces (hard and foam) in different vision states (eyes open and closed) will be performed as a single and dual cognitive or physical task. These tasks will be based on Gentile’s taxonomy, progressing from simple to complex according to each patient’s condition and level of progress. The amount of repetition and the duration of each physical activity will be based on the theory of learning. The balance activity will be designed based on four main parameters: repetition, time, type, and intensity. In terms of the repetition parameter (number of sessions per week), which suggests two to three sessions per week as suitable for balance activity, three sessions per week will be considered. In terms of the time parameter (the duration of physical activity in each session), between 45-60 minutes is deemed the most suitable time for balance activity.
Settings and conduct
Shafa Yahyaian Hospital in Tehran
Participants/Inclusion and exclusion criteria
1-Having idiopathic Parkinson’s disease, as diagnosed by a neurologist and according to the criteria of the Parkinson’s Disease Society Brain Bank in the UK.
Having a disease level of 1 to 3 according to the Hoehn and Yahr scale.
Having a score of 21 or above on the Mini-Mental State Examination.
Intervention groups
Individuals will be placed in an intervention group as available cases.
Main outcome variables
1-Berg Balance Scale
2-Dynamic Gait Index
3-Timed Up and Go
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140612018077N3
Registration date:2023-12-25, 1402/10/04
Registration timing:retrospective
Last update:2023-12-25, 1402/10/04
Update count:0
Registration date
2023-12-25, 1402/10/04
Registrant information
Name
Maryam Mehdizadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 945 4770
Email address
maryam.mehdizadeh_22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-23, 1402/10/02
Expected recruitment end date
2024-05-10, 1403/02/21
Actual recruitment start date
2023-02-02, 1401/11/13
Actual recruitment end date
2023-11-22, 1402/09/01
Trial completion date
empty
Scientific title
Minimal Clinically Important Difference (MCID) for four balance measures in people with Parkinson's disease
Public title
Investigating the clinical application of four balance measurement tools in people with Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having idiopathic Parkinson's disease as diagnosed by a neurologist and based on the Brain Society Parkinson's Disease UK Bank criteria
having disease level 1 to 3 according to the Yahr & Hoehn scale
Having a score of 21 and above in the Mental Mini Examination Stat
Exclusion criteria:
Having other diseases, including diabetes and stroke
Age
From 30 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-11-21, 1402/08/30
Ethics committee reference number
IR.IUMS.REC.1402.751
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
Functional Balance
Timepoint
Before and after intervention
Method of measurement
Timed Up and Go test, Berg balance scale, Dynamic Gait Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Balanced physical activity on different surfaces (hard and foam) in different vision states (eyes open and closed) will be performed as a single and dual cognitive or physical task. These tasks will be based on Gentile’s taxonomy, progressing from simple to complex according to each patient’s condition and level of progress. The amount of repetition and the duration of each physical activity will be based on the theory of learning. Specifically, when a patient can easily repeat a pose three times, the task will become more difficult. This progression will change from standing on two legs with eyes open in a short period of time without a cognitive or physical dual task, to standing on one leg on foam with eyes closed along with a cognitive or physical task.The balance activity will be designed based on four main parameters: repetition, time, type, and intensity. In terms of the repetition parameter (number of sessions per week), which suggests two to three sessions per week as suitable for balance activity, three sessions per week will be considered. In terms of the time parameter (the duration of physical activity in each session), between 45-60 minutes is deemed the most suitable time for balance activity. The type of physical activity (control of the body’s center of gravity from static to dynamic) will be selected based on Gentile’s theory, progressing from simple to complex as described above
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital in Tehran
Full name of responsible person
Maryam Mehdizadeh
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 945 4770
Email
maryam.mehdizadeh_22@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Mehdizadeh
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 945 4770
Email
maryam.mehdizadeh_22@yahoo.com
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
20
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
Maryam Mehdizadeh
Position
Graduated
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 945 4770
Email
maryam.mehdizadeh_22@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Mehdizadeh
Position
Graduated
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 945 4770
Email
maryam.mehdizadeh_22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Mehdizadeh
Position
Graduated
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 945 4770
Email
maryam.mehdizadeh_22@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The participants of this study did not give written consent for their data to be shared publicly, so due to the sensitive nature of the research supporting data is not 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
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
No - There is not a plan to make this available
Title and more details about the data/document
Data available on request due to privacy/ethical restrictions
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
The data that support the findings of this study are available on request from the corresponding author
Under which criteria data/document could be used
Performing advanced analyzes and comparing different diseases
From where data/document is obtainable
The data that support the findings of this study are available on request from the corresponding author.
What processes are involved for a request to access data/document