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.: PACTR201702002005206 Date of Approval: 30/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Correlation between soleus spasticity and ankle range of motion in children with spastic cerebral palsy
Official scientific title Correlation between soleus spasticity and ankle range of motion in children with spastic cerebral palsy
Brief summary describing the background and objectives of the trial Spasticity is a movement disorder characterized by abnormally excessive motor unit activity which is associated with increased muscle tone . Spasticity is considered an important neural contributor to muscle hypertonia in children with cerebral palsy which impair function. The aim of the study is to find a correlation between soleus spasticity and ankle range of motion in children with spastic cerebral palsy, in order to find the proper mangment techiques to control spasticty and to increase the ankle range .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cerebral palsy,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 08/08/2016
Actual trial start date 07/11/2016
Anticipated date of last follow up 16/01/2017
Actual Last follow-up date 30/01/2017
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
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 randomisation using by using procedures such as coin-tossing or dice-rolling Allocation 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 Assessment of spasticity of soleus and assessment of ankle range of motion 1 day 45 minutes Assessment of spasticity of soleus and assessment of ankle range of motion 48 Active-Treatment of Control Group
Experimental Group Assesment spasticity via EMG calculating hoffman reflex to muscle response(H/M) ratio Once 20 minutes Assesment via EMG calculating the 48 Active-Treatment of Control Group
Experimental Group Assesment of Ankle range of motion (ROM) Once 20 minutes Assesment using digital Goniometer 48 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) All children participated in the study were selected according to developmental age which ranges from 9 to 12 month (b) all were at level II on the Gross Motor Function Classification System (GMFCS), which means that they all can stand or ambulate without assistive device (c) degree of spasticity ranged from 1 to 1+ according to the Modified Ashworth scale (A) any fixed contracture in the calf muscle were found(b) surgical intervention (tenotomy operation ) in the lower limbs . 10 Year(s) 2 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 18/07/2016 Cairo university ethical committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed el ziat st. dokii Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Correlation between soleus spasticity and ankle range of motion From August 2016
Secondary Outcome Find a suitable management techniques for physical therapy plan From August 2016
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Cairo university 7 Ahmed elziat St. Dokii Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Facuity of physical therapy Cairo university El tahrir st. Elbohos el dokii 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 el ziat st. dokii Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faten Hassan Abdelazim 7 Ahmed el ziat st. dokii - pediatric physical therapy department faculty of physical therapy Giza 11432 Egypt
Khaled Ahmed Olama 7 Ahmed el ziat st. dokii - pediatric physical therapy department faculty of physical therapy Giza 11432 Egypt
Ehab Ragaa 33 El behous St. el dokii - Neuropediatric department Giza 12622 Egypt
Alaa Noureldeen Kora 19 Mohandseen Blocks - Flat 51 - cairo 11371 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Abdelazim faten.hassan@pt.cu.edu.eg +201008554818 Department of pediatric physical therapy Cairo university
City Postal code Country Position/Affiliation
Giza 11432 Egypt Chairperson of the pediatric physical thetapy deparetment
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 El Salvador Retired instructor
Role Name Email Phone Street address
Scientific Enquiries Khaled Olama k_olama@hotmail.com 01003442838 Pediatric physical therapy department faculty of physical therapy Cairo university
City Postal code Country Position/Affiliation
Giza 11432 Egypt Prof. In department of pediatric physical therapy
Role Name Email Phone Street address
Scientific Enquiries Ehab Ragaa Ehabragaa@gmail.com +201143333959 National research center el behous el dokii
City Postal code Country Position/Affiliation
Giza 12622 Egypt Prof. Of neuropediatrics
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information