The Effect Aquatic Training on the Muscle Strength Lower Extremity in Patients with Chronic Ischemic Stroke: A Randomized Clinical Trial
Design
This clinical trial study with pretest and posttest design was performed on 30 patients with chronic ischemic stroke by available sampling method and classified into 3 groups equal 10: experimental group1 (shallow practice); experimental group 2 (deep training) and control group
Settings and conduct
Examination in the hospital and the protocol for water therapy in the pool. In general, the stages of this research include: 1. Preparing the subjects along with examining the criteria for entering and preparing the data collection tool: General information
Participants/Inclusion and exclusion criteria
A score of 21 to 44 from the berg balance scale
Intervention groups
groups did the aquatic exercise therapy program that included of 18 sessions in 6 weeks and 3 sessions per week for 30 minutes. But the control group did not experience any aquatic exercise
Main outcome variables
Lower Extremity Muscle Strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039626N3
Registration date:2020-01-25, 1398/11/05
Registration timing:retrospective
Last update:2020-01-25, 1398/11/05
Update count:0
Registration date
2020-01-25, 1398/11/05
Registrant information
Name
Hossein Babaeipour
Name of organization / entity
دانشگاه ولی عصر رفسنجان
Country
Iran (Islamic Republic of)
Phone
+98 34 3432 2717
Email address
h.babaei@vru.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-17, 1396/12/26
Expected recruitment end date
2018-04-04, 1397/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Aquatic Training on the Muscle Strength Lower Extremity in Patients with Chronic Ischemic Stroke: A Randomized Clinical Trial
Public title
The Effect of Hydrotherapy in Patients with Stroke
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cerebral stroke and chronic, ischemic stroke
Patients with hemiparesis (slight motor weakness)
Have at least 6 months from the onset of the disease and have a maximum of 2 years
Have the ability to stand without help (at least 5 minutes)
All subjects must be able to walk with or without the aid (at least 10 meters) To have the ability to follow orders
Not participating in regular physical activity and not having a physical therapy program during the study
Desire to participate in the research
The first stroke Patients
50 to 70 years
Exclusion criteria:
Absence in training for 3 sessions
Having a certain diseases
Age
From 50 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Ali Bin Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-03-15, 1396/12/24
Ethics committee reference number
IR.RUMS.REC.1396.207
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Lower Extremity Muscle Strength
Timepoint
At the beginning of the study (before the intervention) and after six weeks of aquatic trainingkvl
Method of measurement
Medical Research Council (MRC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group (shallow) intervenes in depth, with water up to the height of the pelvis, the subjects performed this training session for 6 weeks (18 sessions) and 3 sessions per week for the implementation of the water exercise protocol.
Category
Rehabilitation
2
Description
Intervention group: The second group of interventions (deep) takes place deep in the water to the height of the chest, the subjects performed this training session for 6 weeks (18 sessions) and 3 sessions per week for the implementation of the water exercise protocol.
Category
Rehabilitation
3
Description
Control group: (Without exercise) that the group did not experience any blueprints that had their normal routine during these six weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi Talib Rafsanjan Hospital
Full name of responsible person
Hossein Babaei Pour
Street address
Blvd Imam Ali (AS) , Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3432 2717
Email
hosseinbabaei1906@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr, Alireza Vakilian
Street address
Blvd Imam Ali (AS) , Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
alirezavakilian7@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
50
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
The University of Valiasr Rafsanjan
Full name of responsible person
Hossein Babaeipour
Position
Assistant Professor Valiasr University Rafsanjan
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injuries and Corrective Exercises
Street address
Rafsanjan, Bahman 22 Field, Valiasr University
City
Rafsanjan
Province
Kerman
Postal code
7718897111
Phone
003434322717
Email
hosseinbabaei1906@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Valiasr Rafsanjan
Full name of responsible person
Hossein Babaeipour
Position
Assistant Professor Valiasr University Rafsanjan
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injuries and Corrective Exercises
Street address
Rafsanjan, Bahman 22 Field, Valiasr University
City
Rafsanjan
Province
Kerman
Postal code
7718897111
Phone
003434322717
Email
hosseinbabaei1906@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Valiasr Rafsanjan
Full name of responsible person
Hossein Babaeipour
Position
Assistant Professor Valiasr University Rafsanjan
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injuries and Corrective Exercises
Street address
Rafsanjan, Bahman 22 Field, Valiasr University
City
Rafsanjan
Province
Kerman
Postal code
7718897111
Phone
+98 34 3432 2717
Email
hosseinbabaei1906@yahoo.com
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
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
Title and more details about the data/document
Physical and mental dimension of the patient
When the data will become available and for how long
After submitting and confirming the article
To whom data/document is available
All researchers in this area
Under which criteria data/document could be used
After submitting and confirming the article
From where data/document is obtainable
Hossinbabaei1906@yahoo.com
What processes are involved for a request to access data/document