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.: PACTR201703002088179 Date of Approval: 10/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Functional Corrective Kinesio taping on upper limb spasticity in children with spastic cerebral palsy
Official scientific title Effect of Functional Corrective Kinesio taping on upper limb spasticity in children with spastic cerebral palsy
Brief summary describing the background and objectives of the trial The Kinesio tape have been used in the last years widely on children with spastic cerebral palsy in order to facilitation fine and gross motor function . the aim of our study is to teat the effect of functional corrective techniques of kinesio tape on upper limb spasticity and if its influences spasticity inhibition 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,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/01/2017
Actual trial start date 02/02/2017
Anticipated date of last follow up 31/05/2017
Actual Last follow-up date 31/05/2017
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling 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 Functional Corrective Kinesio Taping plus occupational therapy program 12 sessions 3 month Functional Corrective Kinesio Taping plus occupational therapy program 15 Active-Treatment of Control Group
Control Group Occupational Therapy Program 12 sessions 3 month Occupational therapy program 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Spastic cerebral palsy children in gross motor classification level 2 degree of spasticity 1 to 1+ on modified ashwar scale developmental age above 9 month Any upper limb operation Kinesio tape sensitivity 9 Month(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 20/03/2017 Ethical Committee of faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed elziat st. Dokki Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Degree of Spasticity Hoffman reflex Maximum and muscle response maximum of flexor carpi ulnaris , and their ratio to each other , to measure the degree of upper limb spasticity
Secondary Outcome Wrist extension range of motion Using digital gonimeter is used to measure the available wrist extension range of motion
Secondary Outcome Fine motor skills Peabody fine motor skills will be used in the evluation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university 7 Ahmed elziat st. Dokki Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of physical therapy 7 Ahmed elziat st. Dokki Giza 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University faculty of physical therapy 7 Ahmed elziat st. Dokki Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Alaa Noureldeen Kora 19 Mohandseen Blocks - Flat 51 - Nasr City 11371 Egypt
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
Nasr City 11371 Egypt Retired instructor
Role Name Email Phone Street address
Scientific Enquiries Ehab Ragaa Ehabragaa@gmail.com +201143333959 33 El Behous st. Dokki Neuropediatrics department National Research cente
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