Protocol summary
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Study aim
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Effect of energy conservation strategies on fatigue, function and quality of life in adult with motor neuron disease
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Design
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Clinical trial with control group, with two parallel groups(control and intervention), double blind(patient and assessor), randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Fatigue severity scale, SF36 questionnaire, Canadian occupational performance measure
General information
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Reason for update
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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
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Acronym
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IRCT registration information
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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
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Registration date
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2021-06-03, 1400/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-19, 1400/02/29
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Expected recruitment end date
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2021-09-19, 1400/06/28
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Actual recruitment start date
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2021-05-22, 1400/03/01
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Actual recruitment end date
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2021-10-01, 1400/07/09
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Trial completion date
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2021-11-01, 1400/08/10
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Scientific title
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Effect of energy conservation strategies on fatigue, function and quality of life in adult with motor neuron disease
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Public title
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Effect of energy conservation strategies on fatigue, function and quality of life in adult with motor neuron disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
28
Actual sample size reached:
28
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-09-03, 1398/06/12
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1398.191
Health conditions studied
1
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Description of health condition studied
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Motor neuron disease
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ICD-10 code
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G12.2
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ICD-10 code description
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Motor neuron disease
Primary outcomes
1
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Description
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Function
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Timepoint
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Before, after and one months after treatment
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Method of measurement
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Canadian occupational performance measure
2
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Description
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Fatigue
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Timepoint
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Before, after and one months after treatment
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Method of measurement
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Fatigue severity scale
3
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Description
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Quality of life
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Timepoint
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Before, after and one months after treatment
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Method of measurement
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SF36 questionnaire
Intervention groups
1
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Description
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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
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Category
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Rehabilitation
2
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Description
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Control group(B): Patients participated in 3 weekly, 1-hour occupational therapy sessions provided by an experienced OT in shariati hospital.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The findings of this study will be published as soon as possible.
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When the data will become available and for how long
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2023
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To whom data/document is available
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results will be available for journals readers data will be available for reasonable requests for example systematic reviews
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Under which criteria data/document could be used
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systematic review and meta analysis
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From where data/document is obtainable
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Shariati Hospital, Tehran, Rehabilitation Department
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What processes are involved for a request to access data/document
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Through email; (niloofar.ot92@gmail.com)
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Comments
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