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.: PACTR202001498991714 Date of Approval: 29/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title pediatric physical therapy
Official scientific title Agonist antagonist ratio of elbow muscles and functional abilities in hemiparetic children: randomized control trail
Brief summary describing the background and objectives of the trial Background: Hemiparesis is a common motor impairment that changes physiology of motor unit causing modifications of muscle activation patterns such as inability to recruit the agonist muscles for a certain task, antagonist co-activation and loss of selective activation of groups of muscles necessary to achieve motor skillful tasks and delayed initial and terminal muscular activity. Objective: to detect the relation between agonist antagonist ratio of elbow muscles and functional abilities of upper limb in children with hemiparetic cerebral palsy.
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 10/09/2019
Actual trial start date 09/10/2019
Anticipated date of last follow up 16/11/2019
Actual Last follow-up date 04/12/2019
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 30
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group designed physical therapy program for one hour 3 times per week 6 weeks control group (A) received designed physical therapy program for one hour while study group 15 Active-Treatment of Control Group
Experimental Group designed physical therapy program in addition to strengthening exercise program for triceps brachii 3 time per week 6 weeks study group (B) received the same designed physical therapy program in addition to strengthening exercise program for triceps brachii muscle for six weeks in form of three sessions per week.. The agonist antagonist ratio of elbow muscles was evaluated by the biodex isokinetic dynamometer prior and after six weeks of intervention. Functional abilities were evaluated by Peabody Developmental Motor Scale. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criterion included children that diagnosed as hemiparetic cerebral palsy, able to sit, their age ranged from 5 to 7 years their degree of spasticity ranged from 1 to +1 according to the Modified Ashworth Scale Exclusion criterion of this study included Children who had visual and auditory defects that affect their performance, convulsions, fixed contractures and surgical interventions in the upper extremities. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 7 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 01/12/2019 faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
elzayat Giza 0003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to evaluate the agonist antagonist ratio of elbow muscles 6 weeks
Secondary Outcome to measure functional abilities of hemipelgic chidren 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university elzayat Giza 0003 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mostafa soliman ali elzayat Giza 0003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy Cairo university elzayat Giza 0003 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Heba G. Abd El Aziz elzayat Giza 0003 Egypt
Hamada A.Hamada elzayate Giza 0003 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mostafa ali drmostafamalak9912@gmail.co 00201097720514 elzayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt lecturer of physical therapy
Role Name Email Phone Street address
Public Enquiries heba Abd El Aziz Dr.hebagaber@gmail.com 00201145566003 elzayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt lecturer of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Hamada Hamada Rabiaallah97@yahoo.com 00201003517520 elzayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes here by we the research principle investigators and collaborators along with patients agree to share participant data Statistical Analysis Plan 12 months a third party person will control the shearing and review proper documents calcification and request
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