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General information
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28
28
empty
2021-05-22, 1400/03/01
2021-05-22 00:00:00
empty
2021-10-01, 1400/07/09
2021-10-01 00:00:00
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2021-11-01, 1400/08/10
2021-11-01 00:00:00
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Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
empty
ثبت حجم نمونه تحقق یافته ، تاریخ شروع و پایان نمونه گیری تحقق یافته و تاریخ
خاتمه کارآزمایی
ثبت حجم نمونه تحقق یافته ، تاریخ شروع و پایان نمونه گیری تحقق یافته و تاریخ خاتمه کارآزمایی
Recruitment centers
#1
Name of recruitment center - English: Shariati hospital
Name of recruitment center - Persian: بیمارستان شریعتی
Full name of responsible person - English: Niloofar shirzad
Full name of responsible person - Persian: نیلوفر شیرزاد
Street address - English: No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
Street address - Persian: تهران، خیابان کارگر شمالی، سه راه جلال آل احمد، مرکز آموزشی پژوهشی و درمانی بیمارستان شریعتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1418815516
Phone: +98 21 8490 2110
Fax:
Email: niloofar.ot92@gmail.com
Web page address:
Name of recruitment center - English: Shariati hospital
Name of recruitment center - Persian: بیمارستان شریعتی
Full name of responsible person - English: Niloofar Shirzad
Full name of responsible person - Persian: نیلوفر شیرزاد
Street address - English: No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
Street address - Persian: تهران، خیابان کارگر شمالی، سه راه جلال آل احمد، مرکز آموزشی پژوهشی و درمانی بیمارستان شریعتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1418815516
Phone: +98 21 8490 2110
Fax:
Email: niloofar.ot92@gmail.com
Web page address:
Name of recruitment center - English: Shariati hospital Name of recruitment center - Persian: بیمارستان شریعتی Full name of responsible person - English: Niloofar shirzadShirzad Full name of responsible person - Persian: نیلوفر شیرزاد Street address - English: No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran Street address - Persian: تهران، خیابان کارگر شمالی، سه راه جلال آل احمد، مرکز آموزشی پژوهشی و درمانی بیمارستان شریعتی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1418815516 Phone: +98 21 8490 2110 Fax: Email: niloofar.ot92@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Niloofar shirzad
Full name of responsible person - Persian: نیلوفر شیرزاد
Street address - English: No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
Street address - Persian: خیابان کارگر شمالی، سه راه جلال آل احمد، مرکز آموزشی پژوهشی و درمانی بیمارستان شریعتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1418815516
Phone: +98 21 8490 2110
Fax:
Email: niloofar.ot92@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Niloofar Shirzad
Full name of responsible person - Persian: نیلوفر شیرزاد
Street address - English: No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
Street address - Persian: خیابان کارگر شمالی، سه راه جلال آل احمد، مرکز آموزشی پژوهشی و درمانی بیمارستان شریعتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1418815516
Phone: +98 21 8490 2110
Fax:
Email: niloofar.ot92@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Niloofar shirzadShirzad Full name of responsible person - Persian: نیلوفر شیرزاد Street address - English: No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran Street address - Persian: خیابان کارگر شمالی، سه راه جلال آل احمد، مرکز آموزشی پژوهشی و درمانی بیمارستان شریعتی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1418815516 Phone: +98 21 8490 2110 Fax: Email: niloofar.ot92@gmail.com Web page address:
Protocol summary
Study aim
Effect of energy conservation strategies on fatigue, function and quality of life in adult with motor neuron disease
Design
Clinical trial with control group, with two parallel groups(control and intervention), double blind(patient and assessor), randomized
Settings and conduct
Energy conservation strategies will be held for 3 weeks and one hour per week in the rehabilitation department of Shariati hospital. After obtaining the inclusion criteria and completing the initial consent form, the information of the individuals is recorded. According to the parallel design, patients are randomly divided into two groups of control(B) and treatment(A). Both groups receive routine treatments, but in addition to routine treatment, the treatment group will also attend training sessions on energy conservation strategies. Assessments are completed three times in the first week before treatment, then in the third week after intervention, and finally one-month follow-up. Then all the information will be collected and handed over to the statistics consultant for analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-65 year; Mini mental status exam score more than 24; Beck depression inventory score less than 17; Pittsburgh Sleep Quality Index score less than 5; Fatigue severity scale more than 4; able to walk with or without crutches Exclusion criteria: cardiopulmonary problems; no interests in participation
Intervention groups
Intervention group(A): Patients in the intervention group participated in 3 weekly, 1-hour energy conservation programs provided by an experienced OT.
Control group(B): Patients participated in 3 weekly, 1-hour occupational therapy sessions provided by an experienced OT in Shariati hospital.
Main outcome variables
Fatigue severity scale, SF36 questionnaire, Canadian occupational performance measure
General information
Reason for update
Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
Acronym
IRCT registration information
IRCT registration number:IRCT20210505051194N1
Registration date:2021-06-03, 1400/03/13
Registration timing:registered_while_recruiting
Last update:2021-11-14, 1400/08/23
Update count:1
Registration date
2021-06-03, 1400/03/13
Registrant information
Name
Niloofar Shirzad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6659 6311
Email address
niloofar.ot92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-19, 1400/02/29
Expected recruitment end date
2021-09-19, 1400/06/28
Actual recruitment start date
2021-05-22, 1400/03/01
Actual recruitment end date
2021-10-01, 1400/07/09
Trial completion date
2021-11-01, 1400/08/10
Scientific title
Effect of energy conservation strategies on fatigue, function and quality of life in adult with motor neuron disease
Public title
Effect of energy conservation strategies on fatigue, function and quality of life in adult with motor neuron disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 year
Mini mental status exam score more than 24
Beck depression inventory score less than 17
Pittsburgh Sleep Quality Index score less than 5
Fatigue severity scale more than 4
Patients able to walk with or without crutches
Exclusion criteria:
Patients with cardiopulmonary problems
Patients with no interests in participation in study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
Randomization description
After initial evaluation, samples will be assigned into one of the 2 groups A or B group using sealed envelops, the patients have to pick up one the sealed envelops, so their group will be defined randomly
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 Shahid beheshti University of Medical Sciences
Street address
Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2019-09-03, 1398/06/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.191
Health conditions studied
1
Description of health condition studied
Motor neuron disease
ICD-10 code
G12.2
ICD-10 code description
Motor neuron disease
Primary outcomes
1
Description
Function
Timepoint
Before, after and one months after treatment
Method of measurement
Canadian occupational performance measure
2
Description
Fatigue
Timepoint
Before, after and one months after treatment
Method of measurement
Fatigue severity scale
3
Description
Quality of life
Timepoint
Before, after and one months after treatment
Method of measurement
SF36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group(A): Patients in the intervention group participated in 3 weekly, 1-hour energy conservation programs provided by an experienced OT.The principles used during the ECM program include The importance of rest during the day, energy budgeting, setting rest periods during the day, administration of proper body mechanics and posture, separating of each daily activity to several components, prioritizing activities, teaching ergonomic principles, analyzing and utilization of the way that ADLs are performed, and environmental change. The training sessions were based on the theory of psychoeducational group development and included discussions about the nature of illness and fatigue, setting short-term and long-term goals, doing homework, and execution of strategies at home. In the first session, patients were taught about the MND nature, the effects of fatigue on ADL, and the importance of rest and adjusting rest periods during the day. Patients were asked to explain their daily routine and the barriers they encounter during activities. The patient, along with the OT, sets short rest periods between daily activities at certain times of the day. In the second session, the therapist spoke about the importance of correct body posturing and emphasized on the performing tasks in the sitting position rather than standing. Patients were taught to divide each activity into smaller, easier steps. The third session focused on prioritizing activities during the day, emphasizing on performing hard and exhausting work at the beginning of the day, and the importance of ergonomics and environment modifications
Category
Rehabilitation
2
Description
Control group(B): Patients participated in 3 weekly, 1-hour occupational therapy sessions provided by an experienced OT in shariati hospital.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Niloofar Shirzad
Street address
No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1418815516
Phone
+98 21 8490 2110
Email
niloofar.ot92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloofar Shirzad
Street address
No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1418815516
Phone
+98 21 8490 2110
Email
niloofar.ot92@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloofar Shirzad
Position
Occupational therapist
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1418815516
Phone
+98 21 8490 2110
Email
niloofar.ot92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloofar Shirzad
Position
Occupational therapist
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1418815516
Phone
+98 21 8490 2110
Email
niloofar.ot92@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloofar Shirzad
Position
Occupational therapist
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1418815516
Phone
+98 21 8490 2110
Email
niloofar.ot92@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
The findings of this study will be published as soon as possible.
When the data will become available and for how long
2023
To whom data/document is available
results will be available for journals readers data will be available for reasonable requests for example systematic reviews
Under which criteria data/document could be used
systematic review and meta analysis
From where data/document is obtainable
Shariati Hospital, Tehran, Rehabilitation Department
What processes are involved for a request to access data/document