UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042761 |
|---|---|
| Receipt number | 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 18:34:45 |
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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
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
mina7679@yahoo.com
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048809
