Evaluating the effectiveness of mental imagery on work performance and daily life habits of people with stroke
Design
The present study is a randomized, single-blind clinical trial. It has a control and intervention group that a total of 68 people are studied. Block randomization method is also used for randomization.
Settings and conduct
Samples will be selected from people with stroke in hospital centers affiliated to Tehran University of Medical Sciences, public and private centers in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion:
1. Age range: 30-65
2. Individuals with at least one chronic one-sided stroke, where the duration between the times of the disease is six months or more.
3. Ability to walk at least 10 meters with or without crutches.
4. No perceptual aphasia.
5. No unilateral negligence.
6. Absence of severe depression.
7. Ability to read and write.
8. No articular contractures affecting movement.
9. Appropriate communication skills and minimum mental state examination (MMSE) score of 21 or more.
10. Severe hemiplegic spasticity (modified Ashworth scale score of at least 3).
Exclusion:
1. Severe upper extremity pain with a score greater than or equal to 5 on the visual analog scale.
2. Poor general conditions such as medical or orthopedic problems that have made the client unable to participate in regular rehabilitation.
3. Combined neurological diseases such as Parkinson's disease.
Intervention groups
In the intervention group, there is mental imaging with routine occupational therapy, and in the control group, there is only routine occupational therapy, which is the same time period for both groups.
Main outcome variables
Daily life habits, occupational performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220430054702N1
Registration date:2023-06-20, 1402/03/30
Registration timing:retrospective
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
amirmohammad homayooni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3564 2552
Email address
a.m.homayooni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
2022-06-05, 1401/03/15
Actual recruitment end date
2022-11-16, 1401/08/25
Trial completion date
2023-02-15, 1401/11/26
Scientific title
Effectiveness of Mental Imagery on the Occupational Performance and Life Habits of Persons with Stroke
Public title
The effectiveness of mental imagery in people with stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People with adult stroke are in the age range of 30-65 who have at least one chronic unilateral stroke, on the other hand, the interval between the onset of the disease is six months or more.
References can walk at least 10 meters with or without a cane.
Lack of perceptual aphasia
No unilateral neglect
No severe depression
Be literate
Lack of articular contractures affecting movement
Clients have appropriate communication skills and have a minimum mental state examination score (MMSE) of 21 and above to be able to be intervened.
Severe hemiplegic spasticity (modified Ashworth Scale score at least 3)
Exclusion criteria:
Any severe upper limb pain, with a score greater than or equal to 5 on the analog visual scale
Bad general conditions such as medical or orthopedic problems that have prevented clients from participating in normal rehabilitation
Combined neurological diseases such as Parkinson's disease are present in clients
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will then be divided into control and intervention groups by block randomization method. In the block randomization method, first all 4 blocks that contain two letters A and B are prepared (6 blocks) and we assign a number from 1 to 6 to each of them. Then, using a table of random numbers, numbers from one to six are selected (15 numbers) and the corresponding block will be written based on the selected random number. Doing so will result in a sequence of 60 letters A and B. Each sample will have a number from 1 to 60 if they enter the study, which will receive an A or B code based on the letter list based on each person's number. This is both a coincidence and both groups will be approximately the same.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluation is performed by an occupational therapist who is fluent in the tests and is not part of the research team and is not aware of the study process (the evaluator is blind).
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran, Enghelab St., Pich Shemiran, corner of Safi Alishah St., School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2022-05-29, 1401/03/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.186
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46
ICD-10 code description
Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
The score of daily life habits in the life habit(H-LIFE) questionnaire
Timepoint
The time periods of measuring life habits for the samples are done two weeks before the intervention and two weeks after the intervention.
Method of measurement
Life habits(H-LIFE) questionnaires
2
Description
Occupational performance score in the Canadian Occupational Performance measure(COPM)
Timepoint
Occupational performance measurements for the samples are performed two weeks before the intervention and two weeks after the intervention.
Method of measurement
Canadian Occupational Performance Measure(COPM)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: available samples are included in the study based on the inclusion criteria. Then clients fill part of the demographic information questionnaire and enter the intervention group (routine occupational therapy with mental imagery), daily life habits are measured using the life habits questionnaire (H-Life). Then, the work performance priorities of the samples in the three areas of productivity, self-care and leisure time are determined using the Canadian Work Performance Scale (COPM), and the intervention should be carried out on these priorities. Clients perform their priority functions with the healthy side and using video rotation software, the prepared video is returned and sent to the clients. In the video made, it seems that the person with the involved side is doing an activity, and the video contains 5 functions that are a priority for the reference, and the duration of the video for each function is one minute (5 minutes in total). . Clients should view this video of priority functions before performing the visualization. which later visualizes these priority functions during the therapy session. Intervention protocol: 1- Mental imagery intervention for the intervention group: Mental imagery includes three parts: relaxation, imagination (visualization of prioritized functions) and normalization. The relaxation part (three minutes), fantasy or visualization of priority functions (5 minutes) and normalization (two minutes), which are 10 minutes in total. Mental imagery exercises are performed three times a day (for a total of 30 minutes), 3 times a week for 4 weeks. In all parts, the person should sit in a relaxed and comfortable position (the environment should have minimal noise and distractions). The first part of relaxation: relaxation; It includes three stages of breathing exercises, visualization of a relaxing environment and muscle relaxation. The whole relaxation part lasts for 3 minutes. The first stage of sedation or respiratory sedation; The person is asked to count to 4 and inhale through the nose while counting and then hold his breath and count to 4, then while breathing out to count to 4, finally without breathing again or Exhale for a count of 4 and repeat this process for 25 seconds. The second stage of relaxation; Imagining a relaxing environment: In this step, the person is asked to create a relaxing environment by remembering a relaxing environment or through imagination (for example, a day at the beach or in the forest). The elements of the environment using each of the five senses using commands such as: What do you see? (for example, the blue color of water), . what do you hear (eg waves crashing along the shore), what do you smell? (For example, the fruity scent of sunscreen), what do you smell? (eg, salty sea air), how do you feel? (for example, the heat of the sun). In total, this stage of relaxation takes 50 seconds. The third stage of relaxation; It is muscle relaxation, which consists of 6 steps and includes the following exercises: 1. Starting from the foot, bend the toes under and contract the leg muscles. Hold for 5 seconds, then slowly release for 10 seconds. 2. Contract the calf muscles. Hold for 5 seconds, then release slowly for 10 seconds. 3. Contract the buttock muscles. Hold for 5 seconds, then slowly release for 10 seconds. 4. Contract the abdominal and chest muscles. Hold for 5 seconds, then slowly release for 10 seconds. 5. Contract the shoulder muscles. Hold for 5 seconds, then release slowly for 10 seconds. 6. Contract the muscles of the face (for example, squeeze the eyes). Hold for 5 seconds, then slowly release for 10 seconds. 7. Contract the hand muscles and make a fist. Hold for 5 seconds, then slowly release for 10 seconds. A total of 105 seconds are spent on relaxing the muscles. Second part: imagining and visualizing priority functions; In this section, the references visualize the video made of the priority functions, the duration of which is 5 minutes, and one minute of visualization is considered for each function. The third part: normalization; in this stage, the client is asked to pay attention to the surrounding environment and the real position of his body, and the duration of this stage is 2 minutes. In total, it takes 10 minutes to complete all the mental imaging sections. Therefore, in every session that the client intends to visualize, he must repeat it 3 times a day, which takes a total of 30 minutes of visualization. 2- Routine occupational therapy intervention for the intervention group: Routine occupational therapy includes; Upper body exercises for 15 minutes: carrying a cube, pegboard, holding a cup and sliding objects on the table. Also, 15 minutes of exercises for the lower body: changing from sitting to standing, reaching sitting positions, walking and crossing obstacles, turning and transferring), 30 minutes per session, 3 times a week for 4 weeks. Takes.
Category
Rehabilitation
2
Description
Control group: Includes routine occupational therapy, which includes upper extremity exercises for 15 minutes: carrying a cube, pegboard, holding a cup, and sliding objects on a table. Also, 15 minutes of exercises for the lower body: changing from sitting to standing, reaching sitting positions, walking and crossing obstacles, turning and transferring), 30 minutes per session, 3 times a week for 4 weeks. Takes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaian hospital
Full name of responsible person
Zeynab Sori
Street address
Qazvin Street, Abuzar Square, 20 Meters From Abuzar, Ziaian Medical Training Center
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Fax
+98 21 5575 1333
Email
Ziaeian@tums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Firozgar hospital
Full name of responsible person
Ezat Ab Bariki
Street address
Tehran, Valiasr Square, Karimkhan Zand Street, Beh Afrin Street
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1000
Email
Firoozgarhospital1@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Khanke
Street address
Tehran - Evin - Blvd. Danshju-Kodakyar Street-University of Rehabilitation Sciences and Social Health - Farabi Building - Second Floor
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7173 2832
Email
ha.khankeh@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Amir Mohammad Homayoni
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Faculty of Rehabilitation, Corner of Safi Alishah St., Pich Shemiran St., Tehran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
a.m.homayooni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Mohammad Homayoni
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shemiran St., Tehran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
a.m.homayooni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Mohammad Homayoni
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation faculty, Corner of Safi Alishah St., Shemiran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
a.m.homayooni@gmail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to demographic questionnaires and Canadian life habits and performance are presented in summary form, separately and in files.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Clients and professors, advisors, guides and all researchers
Under which criteria data/document could be used
The general researchers are allowed to use any type of analysis.
From where data/document is obtainable
Send to the recipient's email address.
What processes are involved for a request to access data/document