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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042761
Receipt No. R000048809
Scientific Title The Effects of Neurofeedback and Play Therapy on Dynamic and Static Balance in 4-10 years old Children with Diplegic Spastic Cerebral Palsy
Date of disclosure of the study information 2020/12/29
Last modified on 2020/12/15

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Basic information
Public title The Effects of Neurofeedback and Play Therapy on Dynamic and Static Balance in 4-10 years old Children with Diplegic Spastic Cerebral Palsy
Acronym The Effects of Neurofeedback and Play Therapy in Children with Diplegic Spastic Cerebral Palsy
Scientific Title The Effects of Neurofeedback and Play Therapy on Dynamic and Static Balance in 4-10 years old Children with Diplegic Spastic Cerebral Palsy
Scientific Title:Acronym The Effects of Neurofeedback and Play Therapy in Children with Diplegic Spastic Cerebral Palsy
Region
Asia(except Japan)

Condition
Condition in progress
Classification by specialty
Pediatrics Rehabilitation medicine Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the aim of the examination is to compare the effects of training play therapy and neurofeedback focusing on basic skills on balance among children with cerebral palsy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes neurofeedback therapy may improve the balance of child with spastic diplegic CP
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 neurofeedback therapy
Interventions/Control_2 play therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
4 years-old <=
Age-upper limit
10 years-old >=
Gender Male and Female
Key inclusion criteria Diplegic spastic cerebral palsy levels 1 and 2 according to SCFMG criteria
the age range of 4-10 years
Key exclusion criteria having no basic skills of standing and keeping balance in standing or disability to communicate and comprehend language concepts
Target sample size 30

Research contact person
Name of lead principal investigator
1st name maryam
Middle name
Last name emami korande
Organization Islamic Azad University, Research and Sciences Branch
Division name Research and Sciences Branch
Zip code 1469677542
Address Iran, Tehran, the end of Ashrafi Blv.
TEL 989126900937
Email m.ememi.ot@gmail.com

Public contact
Name of contact person
1st name mina
Middle name
Last name haghighi
Organization Shahrood University of Technology
Division name Physical Education and Sport Sciences Faculty, Biological Sciences Department,
Zip code 3619995161
Address Iran, Semnan, Shahrood, 7 tir squ
TEL 989132310180
Homepage URL
Email mina7679@yahoo.com

Sponsor
Institute Faculty of Literature, Humanities and Social Sciences, Physical Education and Sport Science Department, Islamic Azad University, Research and Sciences Branch, Tehran, Iran
Institute
Department

Funding Source
Organization personal
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Literature, Humanities and Social Sciences, Physical Education and Sport Science Department, Islamic Azad University, Research and Sciences Branch, Tehran, Iran
Address Iran, Tehran, the end of Ashrafi Blv.
Tel 00989132310180
Email mina7679@yahoo.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 08 Month 17 Day
Date of IRB
2020 Year 09 Month 17 Day
Anticipated trial start date
2020 Year 08 Month 31 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 12 Month 15 Day
Last modified on
2020 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048809

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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