Comparison of three rehabilitation approaches; Task oriented, Brunstrom and Bobath on the upper limb function of the stroke patients.
Design
a double blind clinical trial, with parallel's groups, control groups and randomized.
Settings and conduct
This study will be performed in Neurological Physiotherapy Clinic, School of Rehabilitation Sciences. Participants are randomly divided into three groups. Group 1 will receive a combination of task-oriented training and the Brunstrom, the intervention, Group 2 will received a combination of Task-oriented and Bobath training and control group will received Task-oriented training. The assessment will be carried out by a therapist who is unaware of the groups, additionally participants won't be aware of how groups are allocated.
Participants/Inclusion and exclusion criteria
Individuals will be enrolled in this study if they have first unilateral hemiparesis, age range between 45-70 years, Ability to comprehend simple instructions, having motor recovery of hand Brunnstrom stages equal and above 3. They will be excluded if they have previous contracture of the upper extremity and no sitting balance, Having any neurological diseases like Multiple Sclerosis, Parkinson's and so on.
Intervention groups
Interventions will take a 4-week. At that time, participants will be received 12 sessions for 3 days a week. The intervention group1, will receive 60 minute Task-oriented training and Brunstrom training. The second intervention group will receive 60 minutes of Task-oriented training and Bobath training and control group 60 minutes task-oriented training.
Main outcome variables
Upper limb Motor function which are measured by the" Wolf Motor Function Test" and "Fugle-Meyer test".
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140222016680N6
Registration date:2020-04-10, 1399/01/22
Registration timing:registered_while_recruiting
Last update:2020-04-10, 1399/01/22
Update count:0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
Shohreh Noorizadeh Dehkordi
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
noorizadeh.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of three neurological rehabilitation approaches on the function of upper extremity in chronic post stroke hemiparesis patients
Public title
comparison of three neurological rehabilitation approaches on the function of upper extremity in chronic post stroke hemiparesis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Having first unilateral hemiparesis following stroke.
2. confirming stroke by computerized tomography (CT) or Magnetic Resonance Imaging (MRI).
3. Having a stroke for 2 to 12 months ago.
4. Having age range between 45 to 70.
5. Ability to comprehend simple instructions (Score above 20 base on "Mini-Mental State Examination").
6. Score above 3 base on hand motor recovery stages of Brunnstrom approach.
7. Spasticity score of the elbow flexors below 2 base on the "Modified Ashworth Scale".
8. Depression score above 8 base on the "Geriatric Depression Scale".
9. During the study, they are not involved in other rehabilitation programs in upper limbs.
Exclusion criteria:
1. Having previous injury, disease, or contracture in the involved upper extremity
2. Having severe shoulder pain.
3. No sitting balance
4. Having any comorbid neurological disease or conditions such as Multiple Sclerosis, Parkinson Disease, Spinal Cord Injury, Traumatic Brain Injuries, Brain Tumor, Epilepsy or Dementia.
5. Having unilateral neglect.
Age
From 45 years old to 70 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
This study is an experimental and double-blind clinical trial. َAfter finding patients as cases in hand or simple non probable which have inclusion criteria people as absolute random will be divided into three groups using random sealed envelopes. They will be selected randomly by a person who is unaware of the groups. Random blocks (permuted block randomization) with four blocks will be used for randomization. According to the sample size of 24, six blocks will be generated using the online site (www.sealedenvelope.com). For concealment in the randomization process, unique code will be used on each envelope with the type of training specified inside.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants are blind ( each 3 groups will be recieve common task oriented exercises). Assessor who evaluates outcome measures is blind to the groups and kind of treatment. Additionally, data analyzer will be unaware of intervention type and assessments.
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
Iran University of Medical Sciences, Hemmmat Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.IUMS.REC.1398.1276
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G81.1
ICD-10 code description
Spastic hemiplegia
Primary outcomes
1
Description
Motor function in the "Wolf Motor Function Test" and the "Fugl Meyer Assessment"
Timepoint
before intervention, in the middle (6th session) and post intervention (12th session )
Method of measurement
"Wolf Motor Function Test" and "Fugl Meyer Assessment"
Secondary outcomes
1
Description
" dependency in activity of daily living
Timepoint
before intervention, middle (six sessions post intervention) and post intervention (12th session)
Method of measurement
The "Barthel Index"
2
Description
Grip Strength in force tester
Timepoint
before intervention, middle (six sessions post intervention) and post intervention (12th session)
Method of measurement
"Force Tester"
Intervention groups
1
Description
Intervention group1: Participants will receive 30 minute "task oriented training" and 30 minute "Brunstrom training" for 12 sessions (3 session per week). Under supervision of a therapist. patients will receive 14 task oriented activity and 7 Brunstrom training. ٍEach exercise depending on the conditions, will repeat 10- 20 times and will take 2-5 minutes. Required equipment consist of ball, towel, pitcher and mug, shopping bag, button and soda can.
Category
Rehabilitation
2
Description
Intervention group2: Participants will receive 30 minute "task oriented training" and 30 minute "Bobath training" for 12 sessions (3 session per week). Under supervision of a therapist, patients will recieve 14 task oriented activity and 7 Bobath training. Each execise depending on the conditions will repeat 10-20 times and will take 2-5 minutes. Required equipment consisit of ball and mat and bed.
Category
Rehabilitation
3
Description
Control group: Participants will receive 60 minute "task oriented training" for 12 sessions (3 session per week). Under supervision of a therapist, patients will recieve 14 task oriented activity. Each exercise depending on the conditions will repeat 10-20 times and will take 2-5 minutes. Required equipments consist of ball, towel, pitch and mug, shopping bag, button and soda can.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurological Physiotherapy Clinic, School of Rehabilitation Sciences, Iran University of Medical Sci
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Street address
Neurological Physiotherapy Clinic, School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
rehab@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Hemmmat Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4704
Fax
+98 21 8862 2707
Email
amotevalian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Cancellor for Research of 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
Shohreh Noorizadeh Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Position
Assoiate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
shohreh Noorizadeh Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available