Aim of this study is finding proper tool for assessment and treatment of balance in children with cerebral palsy. Study design is triple blinded for patients, researchers and analyzers. Allocation would be randomized. Inclusion criteria necessary for individuals to be involved in study: Children 3 to 10 years old with neurologist diagnose of cerebral palsy; They should be able to stand independently so they should be developmentally in levels before 4 according to Gross Motor Classification System for Cerebral Palsy; their Modified Ashworth’s muscle tone grade should be till 3 in spastic type Study Exclusion Criteria: Dis-cooperation during assessment trial; Distortion in force plate signal recording; Dis-cooperation during vestibular stimulation practice; Being absent in 4 sessions per all or 2 successive sessions ;Being absent for final assessment; Orthopedic disorders (fractures in spinal cord or lower extremity); Epilepsy with confirmation of neurologist.20 children would be selected from cerebral palsied children in Tehran .At first they will be assessed by force plate then intervention group would receive vestibular stimulation accompanied by current occupational therapy in 12 sessions and finally assessed again .Control group will receive only current occupational therapy. We hope that those receiving vestibular stimulation show better balance in these children.Outcome measures are X (Range side way) ، Y(Range foreafter)، area and Mean velocity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021521080N1
Registration date:2015-04-21, 1394/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-21, 1394/02/01
Registrant information
Name
Bahareh Zeynalzadeh Ghoochani
Name of organization / entity
University of Social Welfare and Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 51 3608 3280
Email address
ba.zeynalzadeh@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences Children Research Center
Expected recruitment start date
2015-02-19, 1393/11/30
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating effect of vestibular stimulation on Cerebral-Palsied children balance performance 3-10 year old in Tehran
Public title
Investigating effect of vestibular stimulation on Cerebral-Palsied children 3-10 year old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria necessary for individuals to be involved in study:
Children 3 to 10 years old with neurologist diagnose of cerebral palsy;
They should be able to stand independently so they should be developmentally in levels before 4 according to Gross Motor Classification System for Cerebral Palsy; their Modified Ashworth’s muscle tone grade should be till 3 in spastic type
Study Exclusion Criteria:
Dis-cooperation during assessment trial;Distortion in force plate signal recording;Dis-cooperation during vestibular stimulation practice;Being absent in 4 sessions per all or 2 successive sessions ;Being absent for final assessment;Ortopedic disorders (fractures in spinal cord or lower extremity);Epilepsy with confirmation of neurologist
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomized selection of cerebral palsied children from Tehran Clinics that are under supervision of university of social welfare and rehabilitation sciences and randomized allocation of those into control and intervention groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committe of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin.
City
Tehran
Postal code
1985713834
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
400-190
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
X (Range side way) ، Y(Range foreafter)، (Area (Mean velocity
Timepoint
60s
Method of measurement
forceplate
Secondary outcomes
1
Description
balance strategy
Timepoint
20s
Method of measurement
forceplate
Intervention groups
1
Description
control group: current occupational therapy
Category
Rehabilitation
2
Description
intervention group: vestibular stimulation plus current occupational therapy
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences Centres
Full name of responsible person
Bahareh Zeynalzadeh Ghoochani
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of university of social welfare and rehabilitation sciences; Dr.Rushanak Vameghi, Ch
Full name of responsible person
Dr. Rushanak Vameghi
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
tehran
Grant name
تحقیقات اطفال
Grant code / Reference number
2846/88/4/801
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of university of social welfare and rehabilitation sciences; Dr.Rushanak Vameghi, Ch
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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Bahareh zeynalzadeh ghoochani
Position
student
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
tehran
Postal code
9188637185
Phone
+98 51 3608 3280
Fax
+98 21 2218 0109
Email
b_zeynalzade@yahoo.com
Web page address
www.uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Bahareh zeynalzadeh ghoochani
Position
student
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
tehran
Postal code
9188637185
Phone
+98 51 3608 3280
Fax
+98 21 2218 0109
Email
b_zeynalzade@yahoo.com
Web page address
www.uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Bahareh zeynalzadeh ghoochani
Position
student
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
tehran
Postal code
9188637185
Phone
+98 51 3608 3280
Fax
+98 21 2218 0109
Email
b_zeynalzade@yahoo.com
Web page address
www.uswr.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)