The effect of intensive rehabilitation treatment protocol-based occupational therapy on freezing of gait, psychological symptoms, and quality of life in Parkinson's elderly
the effectiveness of therapy based on occupational therapy based on occupational therapy in improving the gait of the elderly with parkinson 's disease .
Design
a blind , randomized controlled clinical trial .The control group . Parallel group . Over 64 people
Settings and conduct
The intensive rehabilitation protocol based on occupational therapy in the clinic will be performed one hour a day and 5 days a week for a month. The correction is a blind and only the initial outcome assessor is unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
acquiring a higher score from 4 in the freezing questionnaire of راه and 5 , having a minimum literacy rate for the company in research ( part of کاردرمانی cognitive exercises and follow - up ) and obtain -21 and higher scores on the مختصر ( MMSE )؛ severe mental disorders , heart disease and blood pressure , vision problems and the history of deep stimulation stimulation. ( from the medical case of elderly people with Parkinson 's , and asking for their professional doctor )
Intervention groups
The intervention group receives occupational therapy exercises for 4 weeks and 5 days per week for one hour, and its effect on gait problems in Parkinson's patients will be investigated.The control group continues their previous treatment.
Main outcome variables
Evaluation of improvement in gait freezing, psychological symptoms and quality of life with occupational therapy exercises
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170725035278N3
Registration date:2021-03-07, 1399/12/17
Registration timing:registered_while_recruiting
Last update:2021-03-07, 1399/12/17
Update count:0
Registration date
2021-03-07, 1399/12/17
Registrant information
Name
Samaneh Pourhadi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0560
Email address
s.pourhadi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-18, 1400/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intensive rehabilitation treatment protocol-based occupational therapy on freezing of gait, psychological symptoms, and quality of life in Parkinson's elderly
Public title
The effect of intensive rehabilitation treatment protocol-based occupational therapy on freezing of gait, psychological symptoms, and quality of life in Parkinson's elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Achieving a score higher than 4 in the Freezing Walking Questionnaire,,
being in stage 2 to 5 of the severity of Parkinson's disease and Yar
having the minimum literacy to participate in research (part of cognitive occupational therapy exercises and following instructions)
obtaining a score 21 and above In the Mini-Mental State Examination.
age over 60 years
Exclusion criteria:
severe mental disorders. ( from the medical case of elderly people with Parkinson 's , and asking for their professional doctor )
heart disease and blood pressure
vision problems
the history of deep stimulation stimulation
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
the method of allocation of subjects after applying the entry and exit criteria is randomly allocated to the block method . the unit of randomization is individual . the size of blocks may be high and each block is repeated twice . then , using the software soft ware " s software , the sequencing is generated . using this list , which is randomly generated , participants are assigned to one of the two groups . in order to hide a random assignment list , a specific code will be assigned to each intervention group , which is only the main host of the project ( supervisor ) . these codes are written on a paper and sealed inside a sealed envelope . on this paper , as well as the envelope , a unique code for each patient will be written . also , inside each packet is a foil to make the envelope not readable under the light . each packet contains a white paper and a sheet of paper . all packets are arranged in order of random sequence within a box - box and sealed in the seal box . the main researcher , after examining the criteria of entering the study and obtaining informed consent and also registration of the patient " s specifications in special form , is called " " random assignment list " " ( this person is an expert who is involved in the process of entry and entry of the sample ) . also , before opening the envelope , the person must write the name and name of the family and the person 's age on the envelope in such a way that the manuscript falls on the paper in the envelope .
Blinding (investigator's opinion)
Single blinded
Blinding description
According to the type of intervention, only the primary outcome evaluator is unaware of the type of intervention and also the data is provided to the statistical expert for statistical analysis in a blind and randomized code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
IR.MUBABOL.REC.1399.367
Health conditions studied
1
Description of health condition studied
Parkinson's patients
ICD-10 code
G20
ICD-10 code description
Parkinson disease
Primary outcomes
1
Description
Freezing Of Gait
Timepoint
Before and after the intervention
Method of measurement
Freezing Of Gait Questionnaire (FOG)
Secondary outcomes
1
Description
Psychological symptoms
Timepoint
Before and after the intervention
Method of measurement
Brief Symptome Inventory (BSI-18)
Intervention groups
1
Description
Intervention group: Occupational therapy exercises are performed in a clinic using simple sports equipment such as steps, large balls, as well as stationary bicycles or treadmills. The duration of the exercises is 4 weeks and 6 days a week for one hour. They do 5 days in the clinic and one day they have to do exercises at home.
Category
Rehabilitation
2
Description
Control group: There is no specific treatment for these people.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid specialized and sub-specialized clinic
Full name of responsible person
Dr. Payam Saadat
Street address
Ganj Afrooz Street. West side of Ayatollah Rouhani Hospital
City
babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 0045
Email
info@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Reza Ghadimi
Street address
Ganj Afrooz St., Babol University of Medical Sciences, Vice Chancellor for Research
City
babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0560
Email
zkargarian.marvaste@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Zahra Kargarian Marvasti
Position
MSc Student in Aging Health
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0560
Email
zkargarian.marvaste@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Samaneh Pourhadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0560
Email
samaneh.pourhadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Kargarian Marvaste
Position
MSc Student in Aging Health
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0560
Email
zkargarian.marvaste@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available