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.: PACTR201907751587389 Date of Approval: 24/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect Of Heat Versus Cold Application On Balance In Healthy Adolescent Subjects
Official scientific title Effect Of Heat Versus Cold Application On Balance In Healthy Adolescent Subjects
Brief summary describing the background and objectives of the trial Many adolescent are treated with hot or cold modalities prior to therapeutic exercise, but the effects of these treatments on balance are not clear till now. If the balance is altered following therapeutic applications of heat or cold, it is possible to cause injury during rehabilitation,so the purpose of this study is to compare between the effect of heat versus cold application on balance in healthy adolescent subjects.
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 Rehabilitation
Anticipated trial start date 15/07/2019
Actual trial start date 30/07/2019
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date 31/07/2019
Anticipated target sample size (number of participants) 30
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 room temperature at least one hour sitting quite in room temperature 30 Dose Comparison
Experimental Group heat application hot water 40˚c for 15 minutes immersion of the foot and ankle in a hot water 40˚c 30
Experimental Group cold application 1 to 5˚C 15 min immersion of the foot and ankle in cold water 5˚c 30
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. • Their body mass index (BMI) from 5% to 85th percentile for age and sex. • Normal muscle strength in lower limbs. • any foot or ankle injury • cold sensitivities (such as Raynaud’s Disease), • balance or proprioceptive deficits • cardiovascular abnormalities • Professional athletes. • Injury or inflammation of the skin area of ankles and feet, • Impaired sensation in lower limb Adolescent: 13 Year-18 Year,Child: 6 Year-12 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 01/08/2019 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 Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anterior/posterior stability index immediately after finish application ,15 min, of immersion on hot water , cold water or under normal temperature
Secondary Outcome medial/lateral stability index (MLSI) immediately after finish application ,15 min, of immersion on hot water , cold water or under normal temperature
Secondary Outcome overall stability index (OSI). immediately after finish application ,15 min, of immersion on hot water , cold water or under normal temperature
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 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 University
COLLABORATORS
Name Street address City Postal code Country
Marian Magdy Shafeek El-Haram street Giza Egypt
Yomna Farag Ahmed El-Maady Cairo 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 Yomna Ahmed monekareem@gmail.com +2701115162092 El-Maady
City Postal code Country Position/Affiliation
Cairo Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Marian Shafeek Marian.magdy2001@gmail.com +2701224037904 EL-Haram
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