Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202208886771106 Date of Approval: 15/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of Brain Gym exercises on preschool children
Official scientific title Effect of Brain Gym exercises on balance and cognitive abilities in preschool children
Brief summary describing the background and objectives of the trial Preschool children develop rapidly across multiple domains and this determines the next child development pattern . Brain Gym exercise (BG) is an enjoyable and energizing activity directed to enhance brain and body integration, which improves various outcomes, including attention, memory, and academic skills . In this study, the effects of BG on children’s cognitive function and balance achievement were examined.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/06/2021
Actual trial start date 15/06/2021
Anticipated date of last follow up 01/10/2021
Actual Last follow-up date 04/09/2021
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 27
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Brain Gym exercises group 15–30 minutes per day, three times a week for eight consecutive weeks. In our study, Brain Gym movements were selected so that one movement activity from each category was represented; 1-midline movement (cross crawl, lazy 8, neck rolls, belly breathing), 2-lengthening activities (the owel, arm activation), 3-energy exercises (brain buttons, energy yawn), and deepening attitude (hook up). 13
Control Group traditional kindergarten activities 5 days per week 8 weeks traditional educational classes. 14 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) boys and girls between the ages of 4 and 6 years (2) Pediatric balance scale score (from 31 to 53) , (3) ABIQ scores of 95 or less (4) the participant will be physically normal and develop typically according to the parent report and, (5) the ability to understand the assessor’s instructions (1) visual impairment, (2) hearing impairment, and (3) medical drug administration that can cause confusion or make a child less alert Preschool Child: 2 Year-5 Year 4 Year(s) 6 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/01/2021 research ethical committe
Ethics Committee Address
Street address City Postal code Country
ben elsarayat streat Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ‘full scale’ IQ (FSIQ), as well as verbal (VIQ) and nonverbal IQ (NVIQ). Each of them is divided into five subtests: Fluid Reasoning (FR), Knowledge (KN), Quantitative Reasoning (QR), Visual Spatial (VS), and Working Memory (WM) pre evaluation and after two months -end of Brain Gym program-
Secondary Outcome balance pre and post evaluation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kindergartens elhamoul kafrelsheikh Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Samar Taher Elbasuony Elbanna elhamoul kafrelsheikh Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ksfrelshekh univeristy elgesh streat kafrelsheikh Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator samar elbanna samartaher@pt.kfs.edu.eg 00201096058966 Elhamoul
City Postal code Country Position/Affiliation
Kafrelsheikh Egypt assisstant lecturer
Role Name Email Phone Street address
Public Enquiries Shorouk Elshennawy shoroukelshennawy@gmail.com 00201001584522 elmanial
City Postal code Country Position/Affiliation
CAIRO Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Hebatallah Kamal ouda_heba@yahoo.com 00201065263619 eltagmoa
City Postal code Country Position/Affiliation
Cairo Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes yes plan to share IPD Study Protocol 5 months Brain Gym, preschool, children, cognitive, physical, balance
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information