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.: PACTR201702002019178 Date of Approval: 04/02/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title MUSCLE INHIBITION VERSUS FUNCTIONAL CORRECTIVE KINESIO TAPING ON ANKLE FUNCTION IN CHILDREN WITH SPASTIC CEREBRAL PALSY
Official scientific title MUSCLE INHIBITION VERSUS FUNCTIONAL CORRECTIVE KINESIO TAPING ON ANKLE FUNCTION IN CHILDREN WITH SPASTIC CEREBRAL PALSY
Brief summary describing the background and objectives of the trial Cerebral palsy causes a number of motor disorders of that often accompanied by disturbances of sensation, cognition, communication, perception, and/or by a seizure disorder, causing activity limitation. Spasticity and other forms of muscle over activity caused by cerebral palsy may impair function. Kinesio Taping is commonly used in pediatric rehabilitation to reduce pain, facilitate or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support postural alignment, and improve proprioception. Different techniques of application using kinesio taping were found to be effective in patients with cerebral palsy and spasticity. Ankle Functional taping seems to be a promising intervention for improving function in children with cerebral palsy and taping for calf muscles is proved to be valid to reduce spasticity and improve function. The aim of the study is To compare between the muscle inhibitory and the functional corrective Kinesio Taping techniques on spasticity, ankle range of motion and gross motor functional abilities in children with spastic cerebral palsy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Spastic Cerebral Palsy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/08/2016
Actual trial start date 06/11/2016
Anticipated date of last follow up 30/03/2017
Actual Last follow-up date 30/03/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
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 Muscle Inhibitory kinesio taping technique 12 sessions 3 month Muscle Inhibitory kinesio taping technique and physical therapy program 15 Active-Treatment of Control Group
Experimental Group Functional corrective kineso taping technique 12 sessions 3 month Functional corrective kineso taping technique and physical therapy program 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Thirty spastic cerebral palsy children level II according to GMFCS (Gross motor function classification system) selected from the outpatient clinic of the faculty of physical therapy Cairo University, their developmental age ranged from 9 month according to Peabody developmental motor scales, Degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale Instructions. 1. Hypersensitivity to tape 2. Fixed Contractures in the calf Muscle 9 Month(s) 10 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 05/06/2016 Ethical committee of the 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 To compare between the muscle inhibitory and the functional corrective Kinesio Taping techniques on spasticity, ankle range of motion and gross motor functional abilities in children with spastic cerebral palsy. 3 month
Secondary Outcome To find a good reliable method of management using kinsio taping 3 month
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 Cairo university 7 Ahmed elziat st. Dokki Giza 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo university 7 Ahmed elziat st. Dokki Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faten Hassan Abdelazim 7 Ahmed elziat st. Dokki pediatric physical therapy department faculty of physical therapy Giza 11432 Egypt
Khaled Ahmed Olama 7 Ahmed elziat st. Dokki pediatric physical therapy department faculty of physical therapy Giza 11432 Egypt
Ehab Ragaa 33 El Behous st. Dokki Department of neuropediatrics Giza 12622 Egypt
Alaa Noureldeen Kora 19 Mohandseen Blocks - Flat 51 - cairo 11371 Egypt
Khaled Ahmed Olama 7 Ahmed elziat st. Dokk, Department of Physical Therapy For Paediatrics Faculty of Physical Therapy Giza 11432 Egypt
Ehab Ragaa 33 El Behos St. Dokki. Medical Division National Research Center Giza 112622 Egypt
Faten Hasan Abdelazeim 7 Ahmed elziat st. Dokk, Department of Physical Therapy For Paediatrics Faculty of Physical Therapy Giza 11432 Egypt
Osama Ragae Abdelraouf 7 Ahmed elziat st. Dokki ,Departement Of Biomechanics,Faculty of Physical Therapy Giza 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Abdelazim 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 1El Mohendseen buildings
City Postal code Country Position/Affiliation
Cairo 11375 Egypt Retired instructor
Role Name Email Phone Street address
Scientific Enquiries Khaled Olama K_olama@Hotmail.com 00201003442838 7 Ahmed elziat st. Dokki pediatric physical therapy department faculty of physical therapy
City Postal code Country Position/Affiliation
Giza 11432 Egypt Professor of pediatric physical therapy
Role Name Email Phone Street address
Scientific Enquiries Ehab Ragaa Ehabragaa@gmail.com +201143333959 33 El Behous st. Dokki Neuropediatrics department National Research center
City Postal code Country Position/Affiliation
Giza 12622 Egypt Prof. Of neuropediatrics
REPORTING
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