Comparison the effect of simultaneous sensory stimulations and current occupational therapy approaches (neurodevelopmental treatment and rotary vestibular stimulations) on motor development of Down syndrome children with 6 to 18 months of age
The purpose is to compare the efficacy of simultaneous sensory stimulations and two other current occupational therapy approaches on motor development of 6 to 18 month children with Down syndrome. This is a double blind clinical trial using random allocation. All healthy 6 to 18 months children with trisomy 21 and without any orthopedic or neurologic problems will be enrolled in this study. After meeting the inclusion criteria, the infants will be examined by the pediatrician and will then be introduced to occupational therapy ward. Forty four infants with Down syndrome will be randomly assigned into two experimental and control groups. In the occupational therapy ward, they will be evaluated using Gross Motor Function Measure 88 (GMFM 88) by an occupational therapy expert who is blind to the whole study procedure. They will then be treated according to the protocol assigned for each group. Intervention protocol of both groups includes the current occupational therapy approaches (facilitatory techniques of neurodevelopmental therapy and rotary vestibular stimulation). Moreover, the experimental group will also receive simultaneous extroceptive and proprioceptive stimulations by using herbal sticky pasty on the infants' joints. The therapy sessions will be held 3 times a week for 6 months and each session will last for 45 minutes. Both groups will be evaluated 4 times (every 1.5 months) using the GMFM 88 by the same primary therapist and the results will be recorded for each patient. Finally, the data will be analyzed and compared using SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203119259N1
Registration date:2013-01-23, 1391/11/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-23, 1391/11/04
Registrant information
Name
Sepideh Nazi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22227124
Email address
s-nazi@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2006-12-01, 1385/09/10
Expected recruitment end date
2013-02-15, 1391/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of simultaneous sensory stimulations and current occupational therapy approaches (neurodevelopmental treatment and rotary vestibular stimulations) on motor development of Down syndrome children with 6 to 18 months of age
Public title
sensory stimulations on motor development of Down syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :
1 - having trisomy 21 by genetic karyotype
2 - 6 to 18 months of age
3 - having informed consent
4 - having no severe orthopedic problems or malformations, seizure, uncontrolled thyroid disturbances, severe congenital heart problems ( in need for surgery ), perilabour asphyxia ( Apgar of minutes 1 and 5 equal to or less than 7 ), severe visual or auditory problems, weight less than the 3rd percentile of Down syndrome, and history of the neonatal infections ( meningitis, encephalitis )
5 - having gestational age of more than 37 weeks
Exclusion criteria :
1 - use of rehabilitation services, occupational therapy or physiotherapy in other centers,
2 - not attending 3 or more consecutive treatment sessions ,
3 - no participation in treatment sessions for at least 8 sessions in the total intervention course,
4 - any acute or chronic disease which needs hospitalization or surgery during the intervention
Age
From 6 years old to 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The examiner who evaluates the infants and the child's family are blind to the procedure of the therapy and group's allocation . (double blind)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Gross motor development score of GMFM (Gross Motor Function Measure)
Timepoint
4 times evaluations ( before, during, after intervention) every 1.5 month
Method of measurement
GMFM ( gross motor function measure)
Secondary outcomes
empty
Intervention groups
1
Description
The Intervention protocol of the experimental group includes current occupational therapy approaches (facilitatory techniques of neurodevelopmental therapy and rotary vestibular stimulations ) along with simultaneous extroceptive and proprioceptive stimulations by using herbal sticky pasty on shoulder girdles, elbows, hip girdles and knees. This sticky pasty is applied 30 minutes before the session on the joints and is desiccated before the start of the intervention. The therapist then uses bondage on elbows and knees. After bondage, the child will be put in different positions using the current occupational therapy approaches and is encouraged for active movements.
Category
Rehabilitation
2
Description
The intervention protocol of the control group includes current occupational therapy approaches ( facilitatory techniques of neurodevelopmental therapy ( NDT) and rotary vestibular stimulation).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital, Zafar Rehabilitation Center
Full name of responsible person
Sepideh Nazi
Street address
Modares highway, Dastjerdi street, Ali Asghar hospital, Occupational therapy ward
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of University of Social Welfare and Rehabilitation sciences
Full name of responsible person
Dr Hossain Karimi
Street address
Koodakyar Street, Daneshjoo Boulevard, Evin Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of 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
Tehran University of Medical Sciences
Full name of responsible person
Sepideh Nazi
Position
M.Sc. of Occupational therapy, head of Occupational therapy ward of Ali Asghar hospital
Other areas of specialty/work
Street address
Ali Asghar hospital, Dastjerdi Street, Modares Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 2304 6362
Fax
Email
s-nazi@farabi.tums.ac.ir; sepideh.nazi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sepideh Nazi
Position
M.Sc. of Occupational therapy, head of Occupational therapy ward of Ali Asghar hospital
Other areas of specialty/work
Street address
Ali Asghar hospital, Dastjerdi Street, Modares Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 2304 6362
Fax
Email
s-nazi@farabi.tums.ac.ir; sepideh.nazi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sepideh Nazi
Position
M.Sc. of Occupational therapy, head of Occupational therapy ward of Ali Asghar hospital
Other areas of specialty/work
Street address
Ali Asghar hospital, Dastjerdi Street, Modares Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 2304 6362
Fax
Email
s-nazi@farabi.tums.ac.ir; sepideh.nazi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)