the effect of emotional-motor dual-task intervention on the balance of patients with chronic stroke
Design
Clinical trial with a control group, parallel groups, double-blind study, randomized by simple randomization (each patient is assigned a number and individuals are allocated to three groups (n=8) through a random draw), conducted on 24 patients with chronic stroke.
Settings and conduct
This study is being conducted at the Tabassom Stroke Clinic, Firouzgar hospital and rehabilitation school of Iran University of medical sciences. The interventions are conducted over one month (3 sessions per week, totaling 12 sessions). The assessor and patients are blinded to the intervention groups. Furthermore, the individual interpreting and analyzing the study data is also part of the intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Having a first-ever stroke diagnosis by a neurologist according to the International Classification of Diseases(ICD) criteria.
2. No history of any other neurological, orthopedic, psychiatric diseases, acute pain, or addiction based on the patient's report, family history, physician, or medical records.
3. A minimum of 6 months and a maximum of 5 years since the participant's stroke.
4. Ability to walk independently for at least 10 meters with or without assistive devices.
5. No severe depression based on HADS-D<7 and BDI<29.
6. No cognitive impairment based on MoCA >23.
7. Absence of apathy based on DAS <39.
8. Inability to communicate effectively with others
Exclusion criteria:
If a participant shows no interest in continuing participation (absence for two or three consecutive sessions).
If a participant suffers a stroke again.
Intervention groups
1. Emotional-Motor Dual-Task Intervention Group
2. Balance Intervention Group
3. Control Group
Main outcome variables
1. Functional balance
2. Postural control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240512061763N1
Registration date:2024-08-05, 1403/05/15
Registration timing:prospective
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Mohammad Ramadan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3345 0336
Email address
ramadan.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2025-01-04, 1403/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of emotional-motor dual task intervention on balance in chronic stroke patients
Public title
The effect of positive emotions on balance in chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a first-ever stroke diagnosis by a neurologist according to the International Classification of Diseases(ICD) criteria.
No history of any other neurological, orthopedic, psychiatric diseases, acute pain, or addiction based on the patient's report, family history, physician, or medical records.
A minimum of 6 months and a maximum of 5 years since the participant's stroke.
Ability to walk independently for at least 10 meters with or without assistive devices.
No severe depression based on Hospital Anxiety and Depression scale-Depression- Depression subscale<7 and Beck Depression Index<29.
No cognitive impairment based on Montreal Cognitive Assessment>23.
Absence of apathy based on Dimensional Apathy Scale <39
Inability to communicate effectively with others
Exclusion criteria:
If a participant shows no interest in continuing participation (absence for two or three consecutive sessions).
If a participant suffers a stroke again.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The simple random sampling method assigns a unique number to each patient and through a draw, patients are divided into three groups for interventions: emotional-motor dual-task intervention, balance intervention, and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
An individual assigns codes to patients and places each patient's code in an envelope. Then, another person divides the envelopes and codes into three groups. The study evaluator and the statistician are unaware of which codes belong to which individuals. Additionally, since the patients receive the intervention separately, they do not know which group they belong to.
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 Science
Street address
5th floor, Central headquarter building of Iran University of Medical Science, between Chamran and Sheikh Feizollah highway, Hemat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-04-27, 1403/02/08
Ethics committee reference number
IR.IUMS.REC.1403.095
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I69.4
ICD-10 code description
Incl.:Cerebrovascular accident NOSExcl.:sequelae of stroke
Primary outcomes
1
Description
Functional balance
Timepoint
One day before the intervention, one day after the intervention, and one month after the intervention
Method of measurement
Berg Balance scale, Timed up and go test, Activities-based balance confidence
Secondary outcomes
1
Description
Independence in activities of daily living
Timepoint
One day before the beginning of the intervention, one day after the final session of the intervention, and one month after final session of the intervention
Method of measurement
Barthel Index
2
Description
Participation in activities of daily living
Timepoint
One day before the beginning of the intervention, one day after the final session of the intervention, and one month after final session of the intervention
Method of measurement
Canadian Occupational Performance Measure, Meaningful Activity Participation Assessment
3
Description
Depression level
Timepoint
One day before the beginning of the intervention, one day after the final session of the intervention, and one month after final session of the intervention
Method of measurement
Hospital Anxiety and Depression Scale
4
Description
Postural control
Timepoint
One day before the beginning of the intervention, one day after the final session of the intervention, and one month after final session of the intervention
Method of measurement
Force plate(Kistler 5695A, Kistler Instrumente AG Winterthur, Switzerland)
Intervention groups
1
Description
First Intervention group: emotional-motor dual task: This group, unlike the balance intervention group, includes an emotional component in addition to the motor and balance aspects, which is implemented for the patient during balance exercises. After reviewing 6 studies on positive emotion induction methods, 65 positive emotion induction techniques were identified. An expert panel session with professors and occupational therapists in the field of stroke, regarding the examination of these methods, assessing their feasibility for stroke patients, and linking these methods to balance intervention protocol exercises was held. After eliminating similar cases and those that were not feasible or could potentially induce negative emotions such as sadness and hopelessness in patients, 19 methods for positive emotion induction were selected. It is recommended that patients have rest in a calm environment approximately 10 minutes before the start of therapy sessions to attain emotional baseline and be able to participate in the session. Before starting interventions, a list of interests and activities that bring the patient positive emotions can be prepared and discussed during various sessions. The level of balance tasks should not be such that it makes fear and negative emotions in the patient, and even if the level of difficulty of the balance task bothers the patient, this should be considered. It is possible to have a session with patients before starting interventions and provide them with explanations about the intervention process. For individualising the intervention, a questionnaire was designed by the research team so that participants could choose their most desirable methods among 19 selected methods that would bring them more positive emotion. This questionnaire examined the activities and topics of interest of the patients through specific questions. Subsequently, the participants rate the selected methods for inducing positive emotion on a scale of 1 to 10. A score of 10 indicates the highest likelihood of inducing positive emotion, while a score of 1 indicates the absence of positive emotion. Emotional methods agreed upon by expert panel’s members and participants are employed in this group's sessions. These methods are implemented for patients during performing balance exercises. Emotional-motor dual task intervention in this group is carried out over 12 sessions of 45 minutes each(Includes 15 minutes of preparation activities and 30 minutes of emotional-motor dual-task intervention), for 4 weeks, similar to two other groups. The intervention program should not interfere with the individual's regular rehabilitation program.
Category
Rehabilitation
2
Description
Balance Intervention group: Balance Intervention Group: Individuals randomized into the balance intervention group (N=8) will participate in 12 sessions lasting 45 minutes each, comprising 15 minutes of preliminary activities and 30 minutes of balance intervention, over a 4-week period. The balance intervention protocol includes backward walking training and nine other balance exercises. This intervention protocol solely consists of a motor or balance component, with no concurrent activities conducted. Patients are advised to remain standing throughout the session, although rest periods can be provided based on each patient's condition. The intervention program should not interfere with the individual’s regular rehabilitation program.
Category
Rehabilitation
3
Description
Control group: Conventional intervention: Interventions in the control group include stretching and resistance exercises, different walking activities (walking backwards, sideways and at different speeds, going up and down the stairs), balance activities with changing the level of support (standing with different foot positions or on small surfaces) or changes in sensory inputs (such as eyes closed or standing on a foamy surface) and activities related to people's daily functioning. The intensity of exercises (number of repetitions, rest time and repetition time) is determined based on the ability of people during the sessions. The control group also received mentioned interventions in 12 sessions, 45 minutes each and during 4 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabassom Stroke Clinic
Full name of responsible person
Rouzbeh Kazemi
Street address
1st floor, No.26, first of west Bagherkhan, Chamran highway
City
Tehran
Province
Tehran
Postal code
1964635611
Phone
+98 21 6643 6291
Fax
Email
info@tabassomclinic.ir
Web page address
2
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Amin Ghaffari
Street address
Firoozgar hospital, Beh Afarin St. , Valiasr Sq. , Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1000
Email
firoozgarhospital1@gmail.com
3
Recruitment center
Name of recruitment center
School Rehabilitation of Iran University of Medical Sciences
Full name of responsible person
Malahat Akbar Fahimi
Street address
Occupational therapy department, IUMS school of rehabilitation science, Madadkaran St. , Shah Nazari St. , Madar Sq. , Mirdamad Blvd. , Tehran.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷۱۵۴۵۹
Phone
+98 21 2222 8051
Email
rehab@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Neuroscience research center, Iran University of Medical Science, near Milad tower, Shahid Hemat highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4653
Fax
+98 21 8670 4653
Email
nrc@iums.ac.ir
Web page address
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
Mohammad Ramadan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Occupational therapy department, School of rehabilitation science of Iran University of Medical Science, Madadkaran St. , Shahid Shah Nazari St. , Madar Sq. , Mirdamad Blvd. , Tehran.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
Ramadan.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malahat Akbarfahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
occupational therapy
Street address
Occupational therapy department, IUMS school of rehabilitation science, Madadkaran St. , Shah Nazari St. , Madar Sq. , Mirdamad Blvd. , Tehran.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
akbarfahimi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Ramadan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Occupational therapy department, School of rehabilitation science of Iran University of Medical Science, Madadkaran St. , Shahid Shah Nazari St. , Madar Sq. , Mirdamad Blvd. , Tehran.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
Ramadan.m@iums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data from the force place and functional balance will be provided to the research section of occupational therapy and will be shared in meta-analysis studies upon request from the corresponding author.
When the data will become available and for how long
The first part, concerning the provision of data to the occupational therapy training group, occurs after the completion of the thesis and the publication of the article. In the second instance, data will be sent whenever a formal request is received from the authors of the meta-analysis articles.
To whom data/document is available
Research Assistant at Iran University of Medical Sciences
Occupational Therapy Department, Iran University of Medical Sciences
Under which criteria data/document could be used
For further studies in this field based on the suggestions provided in the article and thesis.
From where data/document is obtainable
Authors' Email
What processes are involved for a request to access data/document
Proposals are received via email, and based on the objectives of the proposal, the data is assessed by the research team and made available to the applicant.