Comparing the effectiveness of active and passive vestibular intervention on balance and function in children with spastic Cerebral Palsy (7-12y) Tehran-Iran
This blinded Randomized Control Trail aims to examine:1) The effect of vestibular stimulation on static balance; 2) The relationship between balance changes and Quality of Life and Activity of Daily Living in school aged cerebral palsy children (ages: 7-12 years(.
42 children with spastic cerebral palsy(7-12), with"Gross Motor Function Classification System" level l or ll and vestibular dysfunction according to Bruniniks-Oserstsky Test of Motor Proficiency will be randomized to 3 groups. First group will use active vestibular stimulation for 15 minutes and traditional Occupational Therapy program for 30 minutes. Second group will receive passive vestibular stimulation for 15 minutes and traditional Occupational Therapy program for 30 minutes. Third group (control) will use traditional Occupational Therapy program for 45 minutes.
They will receive these programs for 6 weeks, 3 sessions on week. They will assess at three stages:after, before and 8 weeks after intervention by: VEMP and BOTMP for vestibular system function, Berg and Force Plat for balance changes, "Activities Scale for Kids" for Activity of Daily Living, and "Cerebral Palsy Quality of Life questionnaire "for Quality of Life. Data will be analyzed by "Repeated Measure ANOVA " and "Regression
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082614481N1
Registration date:2013-10-25, 1392/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-25, 1392/08/03
Registrant information
Name
Nazila Akbarfahimi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0037
Email address
n-fahimi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of active and passive vestibular intervention on balance and function in children with spastic Cerebral Palsy (7-12y) Tehran-Iran
Public title
The effect of vestibular interventions on balance and function in children with spastic Cerebral Palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of spastic Cerebral Palsy; age of 7-12 y; to understand experimental procedures; to stand independently for at least 30 seconds; GMFCS( Gross Motor Function Classification System) level l or ll; Modified Ashworth 0-3 score of ankle.
Exclusion criteria:
Orthopedic surgery of the lower limbs within 6 months; history of dislocation, Subluxation,the difference between the length or other obvious deformity in hip ,knee and ankle joint; botulinum toxin injections within 6 months; uncontrolled seizure; moderate to severe intellectual disability; visual or hearing impairment .
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
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
University of Social Welfare and Rehabilitation Sciences
Before, 6 weeks after intervention and 8 weeks later
Method of measurement
Activities Scale for Kids, Cerebral Palsy Quality of Life Questionnaire
2
Description
Balance
Timepoint
Before, 6 weeks after intervention and 8 weeks later
Method of measurement
Force plate, Berg
Secondary outcomes
empty
Intervention groups
1
Description
Control group will receive traditional Occupational Therapy program for 45 minutes. Traditional Occupational Therapy program Consists of: muscle tone moderate, reflexes moderate, muscle stretch, balance training. Intervention duration will be 6 weeks, 3 times in week.
Category
Treatment - Other
2
Description
First intervention group will receive active vestibular stimulation according to special program for 15 minutes. This program developed by Hossieny(2007).Also they will receive traditional Occupational Therapy program (muscle tone moderate, reflexes moderate, muscle stretch, balance training) for 30 minutes. Intervention duration will be 6 weeks, 3 times in week.
Category
Other
3
Description
Second intervention group will receive passive vestibular stimulation by vestibular bed for 15 minutes. Vestibular bed implements controlled vestibular stimulation according to angle, direction and speed of movement. Also they will use traditional Occupational Therapy program (muscle tone moderate, reflexes moderate, muscle stretch, balance training) for 30 minutes. Intervention duration will be 6 weeks, 3 times in week
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Teran Special Education Organization
Full name of responsible person
Vagihoallah Parvizi
Street address
Salimi Jahromi ST, Ayatoallah Kashani Blve, Second Sadeghieh Sq
City
Teharan
2
Recruitment center
Name of recruitment center
Rofideh Rehabilitation Hospital
Full name of responsible person
Ahmad Ali Akbari Kamrani
Street address
Neemati Alley, Baradaran Soleimani St, Gheytarieh
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Hassan Shakeri
Street address
Kodakyar Ave, Daneshjo Blvd, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohammad Reza Khodaee
Position
Vice-chanceller for Education, Student and Cultural Affairs
Other areas of specialty/work
Street address
Kodakyar Ave, Daneshjo Blvd, Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0016
Fax
Email
amozesh@uswr.ac.irkh.ardakani@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Seyed Ali Hosseini
Position
Ph.D. Occupational Therapist
Other areas of specialty/work
Street address
Kodakyar Ave, Daneshjo Blvd, Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0123
Fax
Email
sahosseini@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences