The present research is a randomized clinical trial. In order to study the effect of the Dohsa-hou psychomotor rehabilitation on the gross motor function in children with spastic cerebral palsy aged 4-12. The present research is an experimental study.
Participants: 24 children with cerebral palsy (spastic) aged 4-12 based on inclusion criteria will be entered in the study.
Intervention: The present study will be carried out in winter and Spring 2017 .In the control group, 12 children with spastic cerebral palsy will receive the common training. In the intervention group, 12 other children with spastic cerebral palsy will receive the Dohsa-hou psychomotor rehabilitation 2 sessions a week for 6 weeks (each session lasts 45 minutes). Participants of both groups will be evaluated before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120726926N2
Registration date:2016-12-31, 1395/10/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-31, 1395/10/11
Registrant information
Name
Karim Ayoubi Avaz
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3334 0867
Email address
ayoubikarim@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-18, 1396/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of psycho motor rehabilitation (Dohsa-hou) on the gross motor function in children with spastic cerebral palsy (4-12 years)
Public title
The effectiveness of psycho motor rehabilitation (Dohsa-hou) on the gross motor function
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Being aged 4-12; affliction with spastic hemiplegia based on the diagnosis of a specialist; impairment in the gross motor skills; high muscle tone; parents’ consent for participation of their child in the study; and child’s ability to do the exercises. Exclusion criteria: Taking anti-seizure drugs; chromosomal disorders or multiple disabilities; having musculoskeletal surgeries over the last six months; affliction with renal, cardiorespiratory; and endocrine diseases; hip dislocation; the absence of more than two sessions during the intervention period and injection of botulinum toxin during the past three months.
Age
From 4 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Km 5 Semnan to Damghan Road, Semnan
Intervention group : The intervention will consist of 12 sessions of 45 minute psychological rehabilitation program by Dosah method for patients with cerebral palsy which is designed in Japan by Professor Naroseh will be taught. The program consists of two parts of psychological and physiological which are taught by the therapist.
Category
Rehabilitation
2
Description
Control group: common interventions in care center
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Neruromuscular Rehabilitation Research Center
Full name of responsible person
Karim Ayoubi Avaz
Street address
No.47,Semnan University of Medical Sciences, Basij Blvd, Semnan, Iran
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidipour
Street address
No.47,Semnan University of Medical Sciences, Basij Blvd, Semnan, Iran
City
Semnan
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, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Karim Ayoubi Avaz
Position
Master of siences / Faculty member
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Rehabiliation depatement, Km 5 Semnan to Damghan road, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ayoubikarim1@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Karim Ayoubi Avaz
Position
Master of sciences
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Rehabiliation depatement, Km 5 Semnan to Damghan road, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ayoubikarim1@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Karim Ayoubi Avaz
Position
Master of siences / Faculty member
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Rehabiliation depatement, Km 5 Semnan to Damghan road, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)