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.: PACTR201704002181361 Date of Approval: 06/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Long term effect of kinesotaping application on children with spastic cerebral palsy
Official scientific title Long term effect of kinesotaping application on children with spastic cerebral palsy
Brief summary describing the background and objectives of the trial Kinesotape is a method of management that have been introduced to be used to modulate spasticity in calf muscles and increase range of motion in ankle joint. The aim of the study is to measure if the Kinesio taping have a long lasting effect on these measure or not .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cerebral palsy,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2017
Actual trial start date 27/03/2017
Anticipated date of last follow up 24/07/2017
Actual Last follow-up date 06/06/2017
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants) 15
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 Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification (please specify factors used for stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Kinesotape application plus physical therapy program 12 sessions 3 month Application of KinesioTaping with specific designed physical therapy pragram 15 Active-Treatment of Control Group
Control Group Physical therapy program 4 sessions 1 month Physical therapy program 15 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Modified Ashworth scale 1 and 1+ Developmental age ranges from 9 to 12 months Gross motor functional classification system level 2 Tentomy operation for calf muscles 1 Year(s) 5 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 12/04/2017 The ethical commitee of the faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed el ziat st. Doki Giza Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To measure if the effect of kinesotaping lasts on spasticity After one month of last application of KinesioTaping we measure the h/m ratio again to see how long term is kinesiotaping is effective
Secondary Outcome To measure the ankle range of motion After the last kinesotape application we measure the ankle range of motion to see the long term effect of the tape
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Cairo university 7 Ahmed elziat st. Dokki giza doki Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of physical therapy 7 Ahmed elziat st. Dokki pediatric physical therapy department faculty of physical therapy Giza 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy 7 Ahmed elziat st. Dokki faculty of physical therapy Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faten Hasan Abdelaziem 7 Ahmed elziat st. Dokki pediatric physical therapy department faculty of physical therapy Giza 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator faten Abdelaziem Faten.hassan@pt.cu.edu.eg 00201008554818 7 Ahmed elziat st. Dokki pediatric physical therapy department faculty of physical therapy
City Postal code Country Position/Affiliation
giza 11432 Egypt Chairperson of pediatric physical therapy department
Role Name Email Phone Street address
Public Enquiries Amany Abdelfattah Abdelfatahamany@gmail.com 00201003311449 19 Mohandseen Blocks - Flat 51 -
City Postal code Country Position/Affiliation
cairo 11371 Egypt Former investigator in the teaching minster
Role Name Email Phone Street address
Scientific Enquiries Ehab Ragaa Ehabragaa@gmail.com 00201143333959 33 El Buhouth St. Doki
City Postal code Country Position/Affiliation
giza 12622 Egypt Prof. Of neuropediatrics
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information