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.: PACTR201908659527420 Date of Approval: 20/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of smart phone uses on dynamic balance in healthy adolescent subjects
Official scientific title Impact of smart phone uses on dynamic balance in healthy adolescent subjects
Brief summary describing the background and objectives of the trial In last years the use of smartphone has increased rapidly and noticeable in adolescent, especially in the summer school holidays, where they increasingly use it in games and social media. Previous studies reported the negative impact of smartphone on both physical and psychological aspect in their users but limited studies investigate its impact in adolescent users and till now no studies investigate its impact on their balance immediately after using smartphone. If balance is altered following smart phone using it may cause injury during daily tasks especially walking and ascending and descending stair.
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 Early detection /Screening
Anticipated trial start date 15/09/2019
Actual trial start date
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Crossover: all participants receive all interventions in different sequence 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
Control Group before using smart phone not use smart phone for at least the last 6 hours the participant will not use smart phone for any activities for at least 6 hours later 50 Dose Comparison
Experimental Group immediately after using smart phone and after one hour later using smart phone for texting, chatting or playing preferred game for at least 30 continuous minutes using smart phone for texting, chatting or playing preferred game for at least 30 continuous minutes and after first assessment repeat assessment one hour later (this hour free of using smart phone) 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy normal subjects. Age ranged from 12 to 18 years. Smart phone users Their body mass index (BMI) from 5% to 85th percentile for age and sex. Normal muscle strength in lower limbs. Balance or proprioceptive deficits Musculoskeletal or neurological disorders in lower limbs. Visual, auditory or vestibular deficits. Previous dizziness Adolescent: 13 Year-18 Year 13 Year(s) 18 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
No 10/09/2019 Faculty of Physical Therapy Research Ethics Officer
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome overall stability index (OSI) before ,immediately after using smart phone for 30 minutes and one hour later after using smart phone for 30 minutes
Secondary Outcome Anterior/posterior stability index before ,immediately after using smart phone for 30 minutes and one hour later after using smart phone for 30 minutes
Secondary Outcome medial/lateral stability index (MLSI) before ,immediately after using smart phone for 30 minutes and one hour later after using smart phone for 30 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Modern University for Technology and Information El-Moustashar Mohammed Mostafa, Al Abageyah, Qism El-Khalifa, Cairo Governorate Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Modern University for Technology and Information El-Moustashar Mohammed Mostafa, Al Abageyah, Qism El-Khalifa, Cairo Governorate Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Modern University for Technology and Information El-Moustashar Mohammed Mostafa, Al Abageyah, Qism El-Khalifa, Cairo Governorate CAIRO Egypt University
COLLABORATORS
Name Street address City Postal code Country
Marian Magdy Shafeek El-Haram street Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marian Shafeek Marian.magdy2001@gmail.com +2701224037904 El-Haram street
City Postal code Country Position/Affiliation
Giza Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Marian shafeek Marian.magdy2001@gmail.com +2701224037904 El-Haram street
City Postal code Country Position/Affiliation
Giza Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Marian Shafeek Marian.magdy2001@gmail.com +2701224037904 El-Haram street
City Postal code Country Position/Affiliation
Giza Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data under lie the results reported in this article (text, tables, figures, appendices) Statistical Analysis Plan,Study Protocol beginning from 6 to 12 months after publication controlled access through authors mails
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