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The investigation of the effect of fatigue's prediction during unilateral upper extremity exercises on upper extremity function, activities of daily living and participation in chronic stroke patients

Protocol summary

Study aim
The effect of fatigue prediction in the form of unilateral upper limb movement exercises on upper limb function, daily activities of life and participation of people with chronic stroke
Design
Randomised control trial with control group, double blind
Settings and conduct
This is a randomized clinical trial study. Sampling from neurology outpatient clinics is conducted. Then the eligible participant fill out form of willingness, they will randomly be assigned to groups (intervention, control).This is a double blind study. The examiner and all of the participant are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Having only one experience of stroke, - Having an injury to the middle cerebral artery, -Not having unilateral neglect, -The level of upper extremity function according to Brunstrum ≥3, - level to MMSE ≥21, - Beck Depression Inventory <31, - no history of other neurological or orthopedic conditions. Exclusion criteria: - Noting Have chronic fatigue, Patients who are at an acute stage of stroke, -Noting Have chronic depression
Intervention groups
1) The control group: for an hour and a half of rehabilitation treatment routine includes stretching exercises, range of motion , activities of daily living , as well as exercises in the brunstrum approach and the PNF, 2) intervention group no prediction of fatigue: in this group of patients to the routine exercises for 30 minutes Routine occupational therapy treatment and bilateral upper extremity exercises an hour doing on the fly each time that the patient will feel tired to change exercise type. 3) intervention group with the prediction of fatigue: in this group of patients to the routine occupational therapy exercises for 30 minutes and one hour bilateral upper extremity exercises with the use of kinect
Main outcome variables
Function of upper extremity, Activity of daily living , Participation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140416017301N7
Registration date: 2019-06-13, 1398/03/23
Registration timing: registered_while_recruiting

Last update: 2019-06-13, 1398/03/23
Update count: 0
Registration date
2019-06-13, 1398/03/23
Registrant information
Name
Akram Azad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 2450
Email address
azad.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of the effect of fatigue's prediction during unilateral upper extremity exercises on upper extremity function, activities of daily living and participation in chronic stroke patients
Public title
The investigation of the effect of fatigue's prediction during unilateral upper extremity exercises on upper extremity function, activities of daily living and participation in chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Occurrence of the first stroke Damage of middle artery cerebral according to physician report in MRI Between 6 months to 5 years interval from onset of stroke Not having unilateral neglect (Star Cancellation Test more than 44) In the terms of brunstroms motor recovery stages, patients should be at least in the 5 stage of arm and 4 in the hand. In the terms of cognitive function to get Mini Mental Status Examination (MMSE) more than 21 In the terms of depression to get Beck Depression Inventory (BDI) under 31 Has not report any other problem like orthopedic, neurological or rheumatology that to be again limitation in upper extermity
Exclusion criteria:
Recurrence of stroke in the implementation of the plan Unwillingness of patients to continue the design process at any time from the stage of work The occurrence of other problems, including orthopedic, rheumatology or neurological affecting the function of upper extremities during the implementation of the plan
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 20
Samples will be selected from chronic stroke patients referring to rehabilitation centers in Tehran. According to inclusion criteria, the samples will be randomly blocked and assigned in three groups (receiving uni-lateral motor exercises with/ without fatigue's prediction and control group).
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is a simple inaccurate (accessible) type. According to inclusion criteria, the samples will be randomly blocked in three groups (receiving uni-lateral motor exercises with/ without fatigue's prediction and control group). In this way, eligible individuals and volunteers to participate in the study will be placed in the three groups using the bald throwing method
Blinding (investigator's opinion)
Double blinded
Blinding description
The examiner is blind and all of the participant are blind too.
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 Sciences
Street address
School of Rehabilition, Shahnazari Ave., Moder Square,. Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913187
Approval date
2018-09-17, 1397/06/26
Ethics committee reference number
IR.IUMS.REC.1397.653

Health conditions studied

1

Description of health condition studied
stroke
ICD-10 code
164
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
Function of Upper Extremity
Timepoint
Before, after and 3 month after intervention
Method of measurement
Box-Block Test (BBT), Purde-Pegboard Test (PPT), Wolf Motor Function Test (WMFT), Fugle-Meyer Upper Extremity Assessment (FMA-UE), Shoulder Position Sense Test (SPST), Elbow Position Sense Test (EPST)

2

Description
Activity of Daily Living (ADL)
Timepoint
before, after and 3 month after intervention
Method of measurement
Shah Barthel Index (Shah BI)

3

Description
Participation
Timepoint
before, after and 3 month after intervention
Method of measurement
Canadian Occupational Performance Measure (COPM)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group no prediction of fatigue: In this group of patients to the routine exercises for 30 minutes routine occupational therapy treatment and unilateral upper extremity exercises an hour doing on the fly each time that the patient will feel tired to change exercise type.
Category
Rehabilitation

2

Description
Intervention group: intervention group with the prediction of fatigue: In this group of patients to the routine occupational therapy exercises for 30 minutes and one hour unilateral upper extremity exercises with the use of Kinect.
Category
Rehabilitation

3

Description
The control group: For an hour and a half of rehabilitation treatment routine includes stretching exercises, range of motion , activities of daily living , as well as exercises in the brunstrum approach and the PNF.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
School of rehabilitation clinic, Firoozgar hospital, Shafa-Yahyaian hospital
Full name of responsible person
Akram Azad
Street address
Shahnazari Ave., Moder Square,. Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
azad.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akram Azad
Street address
School of Rehabilitation, Shahnazari St., Mirdamad Blv., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
azad.a@iums.ac.ir
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
30
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
Akram Azad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahnazari Ave., Moder Square,. Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
azad.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akram Azad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahnazari Ave., Moder square., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
azad.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akram Azad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahnazari Ave., Moder Square., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 212228051
Email
azad.a@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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Give code to each participant
When the data will become available and for how long
At least one year after the completion of the design and publication of the related article
To whom data/document is available
Research group
Under which criteria data/document could be used
En Just by giving code
From where data/document is obtainable
Research group
What processes are involved for a request to access data/document
Not decided
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