Comparison the effect of oral motor stimulations on feeding function in the children with spastic cerebral palsy by medical and family centered approach
The object of this studty is Comparison the effect of oral motor stimulations on feeding function in the children with spastic cerebral palsy by medical and family centered approach.Design: The population under study is all of the 2 to 8 years old children with cerebral palsy at the city of Arak.group: The children under clinician management and the children under family management. Sample size: 40 children. Randomization:The items were selected by simple randomization. The inclusion criteria include: Diagnosis of Spastic cerebral palsy children by neurologist.spastic CP children 8-2 years.Children obtain score 3-5 from GMFCS-E & R scale. Parent have consent for children s participation in the study. the exclusion criteria include: Existence and prooof intreatable seizures in children.Existence mouth Anomalies such as cleft palate in children at the time of project.The management was oral motor stimulation. Study time was 1 month. Outcomes studied was increasing swallowing skills of patients
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060828345N1
Registration date:2016-06-29, 1395/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-29, 1395/04/09
Registrant information
Name
Abdolreza Yavari
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 863685006
Email address
a.yavari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Arak University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral motor stimulations on feeding function in the children with spastic cerebral palsy by medical and family centered approach
Public title
The effect of oral motor stimulations on feeding function
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria include: Diagnosis of spastic cerebral palsy children by neurologist; Spastic CP children 8-2 years; Children obtain score 3-5 from GMFCS-E & R scale; Parent have consent for children s participation in the study. The exclusion criteria include: Existence and prooof intreatable seizures in children; Existence mouth Anomalies such as cleft palate in children at the time of project.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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 Arak University of Medical Sciences
Street address
Arak. Sardasht, Arak University of Medical Sciences
City
Arak
Postal code
3848176941
Approval date
2015-07-11, 1394/04/20
Ethics committee reference number
IR.ARAKMU.REC.1394.74
Health conditions studied
1
Description of health condition studied
spastic cerebral palsy
ICD-10 code
G80,G81,G8
ICD-10 code description
heredity spastic paraplegia
Primary outcomes
1
Description
feeding function
Timepoint
pre and post management
Method of measurement
Oral motor assessment scale
Secondary outcomes
empty
Intervention groups
1
Description
On the children that were selected ,oral -motor stimulation approach for 15 minutes a day, 3 days a week, for 12 sessions was done by therapist.
Category
Other
2
Description
Intervention group 1: On the children that were selected ,oral -motor stimulation approach for 15 minutes a day, 3 days a week, for 12 sessions was done by trained family
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tolue Rehabilitation Clinic
Full name of responsible person
Doctor Hamid Dalvand- ،اThe head of Department of Occupational Therapy
Street address
Alamolhoda street- pastor avenue- Park entrance
City
arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical sciences
Full name of responsible person
Dr Mohamad Rafie
Street address
Sardasht, Basij Square, Arak University of Medical sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Arak University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rehabilitation College
Full name of responsible person
Akram Valizade
Position
Mastery Science/ Faculity Member
Other areas of specialty/work
Street address
Mostafa Street, Golestan Avenue, Rehabilitation College
City
Arak
Postal code
Phone
+98 86 3368 5006
Fax
Email
akramvalizadeh59@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rehabilitation College
Full name of responsible person
Dr Hamid Dalvand
Position
PHD
Other areas of specialty/work
Street address
Mostafa Street, Golestan Avenue, Rehabilitation College
City
Arak
Postal code
Phone
+98 86 3368 5006
Fax
Email
hamiddalvand@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rehabilitation College
Full name of responsible person
Abdolreza Yavari
Position
Mastery science/ Faculity Member
Other areas of specialty/work
Street address
Mostafa Street, Golestan Avenue, Rehabilitation College
City
Arak
Postal code
Phone
+98 86 3368 5006
Fax
Email
abdolrezayavari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)