Determine the effect of hydrotherapy on motor evolution and spasm in infants with cerebral palsy.
Design
A clinical trial is a randomized, two-group randomized, pre-test, and post-test. The selection of units of study is available in (easy) among children with cerebral palsy eligible who have criteria for entry to study. Then, The research units were randomly allocated and homogenized into two groups of intervention (receiving hydrotherapy) and control.
Settings and conduct
Perform intervention:
The patients will work under the supervision of a researcher and physiotherapist, who will be held for 8 weeks a weekly 3 times in 1-hour sessions, 15 minutes for maternity and dressing for one or two days. Due to administrative conflicts in the morning shift and the relative relaxation of the hospital in the shift in the era of intervention in the shift of the evening.
Measurement of the second stage:
After the intervention in the intervention group (the eighth week after the intervention), the second stage will measure the criteria for fine motor development and the score for spasm. At this stage, as in the first stage, the evolutionary clinic of the Ghayeg hospital Billy and Ashworth will be used to measure the evolutionary criteria in the sensory-motor field and the spasm scores
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Iranian citizenship and resident of Mashhad.
2) Diagnosis of cerebral palsy for infant is confirmed by the relevant physician.
3) The age of the infant is between 1 and 10 months.
Exit criteria:
1) The primary caregiver of the child is not willing to cooperate.
Intervention groups
Infants with cerebral palsy with hydrated intervention
Main outcome variables
Main variables include spasm scores of the upper and lower extremities, and the elevated and gross motor development of infants with cerebral palsy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180427039440N1
Registration date:2019-01-17, 1397/10/27
Registration timing:retrospective
Last update:2019-01-17, 1397/10/27
Update count:0
Registration date
2019-01-17, 1397/10/27
Registrant information
Name
zainab razmyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3523 5505
Email address
razmyarz931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-26, 1395/11/07
Expected recruitment end date
2017-01-26, 1395/11/07
Actual recruitment start date
2017-01-26, 1395/11/07
Actual recruitment end date
2018-01-27, 1396/11/07
Trial completion date
2019-01-09, 1397/10/19
Scientific title
Effects of hydrotherapy on the motor development and spasm scores of the cerebral palsy infants
Public title
Effects of hydrotherapy for cerebral palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of cerebral palsy for the infant will be confirmed by the relevant physician.
The age of the infant is between 1 and 10 months.
Parents have a tendency to participate in the study.
According to a physician's diagnosis, with cerebral palsy, there is no physical illness or disorder in other systems of the body, such as any kidney and digestive problems and diabetes.
No malnutrition.
Exclusion criteria:
The child's primary caregiver does not want to cooperate.
The infant is admitted or required to undergo surgery.
During the intervention, diagnose any disease that affects the development process by the doctor for infants.
The infant dies during the intervention.
Age
From 1 month old to 10 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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Turn off instant translation
980/5000
Selection of available research units is easy for children suffering from cerebral palsy who have criteria for entering the study. Subsequently, the units were randomly assigned and homogenized into two groups of intervention (receiving hydrotherapy) and dividing control They must be homogeneous in terms of gender and age before intervention. Before the sampling begins, by assigning either a pair or a person to a control or intervention group, the random numbers are sequentially numbered n (the sample size is a total of two The group is selected based on the number of pairs or individuals. The sequence of children selected by group Control and intervention. For example, if the individual numbers are assigned to the control group and the pair numbers to the intervention group, then the sequence of the numbers selected from the random number table is 8.5.1.4.2.1-6.0.7.7 The allocation of children to The two groups will be based on the sequence of referrals: intervention "control" intervention control "intervention" control "intervention" none "control. Choosing this random allocation method is due to the allocation of resources before the study begins, and no factor affects it during the research.
Blinding (investigator's opinion)
Double blinded
Blinding description
Given the random selection of participants and their insertion in the control and intervention group and the use of code instead of the name for data analysis
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Faculty of Nursing University Street, Crossroad of the Ph.D.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
IR.MUMS.REC.1395.509
Health conditions studied
1
Description of health condition studied
Cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Motor Development and Spasm of the infants
Timepoint
Before and after the intervention
Method of measurement
Billy and Ashworth tools
Secondary outcomes
1
Description
Fine moor development, Groos motor development and spasm the Infanti
Timepoint
Before and after the intervention
Method of measurement
Billy and Ashworth tools
Intervention groups
1
Description
In the intervention group, the patients will be under the supervision of a researcher and physiotherapist, who will be held for 8 weeks a weekly 3 times in 1-hour sessions, 15 minutes for maternity leave and alternate dresses on individual or coupled days. will be. Due to administrative conflicts in the morning shift and the relative relaxation of the hospital in the shift in the era of intervention in the shift of the evening. Measurement of the second stage: After the intervention in the intervention group (the eighth week after the intervention), the second stage will measure the criteria for fine motor development and the score for spasticity, which is similar to the first stage in the evolutionary clinic of Ghayegh Hospital Billy and Ashworth evolutionary tools will be used to measure the evolutionary criteria in the sensory-motor field and the spasm score. The control group will be evaluated without any intervention at the beginning and end of the work.
Category
Rehabilitation
2
Description
Control group: In the control group, without any intervention, will be evaluated only at the beginning of the work and the end (end of the two months).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad, Hospital Ghaem
Full name of responsible person
Zainab Razmyar
Street address
Ahmad Abad Ave, Dr. Shariati Square (Taghi Abad),
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
razmyarz931@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Said eslami
Street address
University of Mashhad, Faculty of Nursing and Midwifery, Ibn Sina St., Ph.D.
City
MASHHAD
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 7313
Email
razmyarz931@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zainab Razmyar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO.3, HEJAB1, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3523 5505
Fax
Email
razmyarz931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zainab Razmyar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO:37, HEJAB11, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3523 5505
Fax
Email
razmyarz931@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zainab Razmyar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO:37, HEJAB11, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3523 5505
Fax
Email
razmyarz931@mums.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