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.: PACTR202103520585635 Date of Approval: 26/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Immediate effect of core- stability exercise on myoelectric activity of trunk and lower extremity muscle in children with spastic cerebral palsy.
Official scientific title Immediate effect of core- stability exercise on myoelectric activity of trunk and lower extremity muscle in children with spastic cerebral palsy.
Brief summary describing the background and objectives of the trial Rehabilitation or performance enhancement training should be based on the principle that specific imposed demands on the musculoskeletal system will produce specific adaptations within the system. Exercises designed to increase strength or endurance should target specific muscle groups that are weak or are important to the activities in which the individual wants to participate. A clinician should be able to establish a specific exercise program that includes optimal exercise positions to target specific identified muscular performance deficits. Electromyographic (EMG) analysis can provide information as to the relative amount of muscular activity an exercise requires, as well as the optimal positioning for the exercise. The exercises analyzed are often used in rehabilitation programs. They are active exercises using body weight for resistance; thus a clinician is unable to determine the amount of resistance being applied to a muscle group. Electromyographic (EMG) analysis can provide a measure of muscle activation so that the clinician can have a better idea about the effect the exercise may have on the muscle for strength, endurance, or stabilization. (Ekstrom et al, 2007)
Type of trial CCT
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 13/02/2021
Actual trial start date 10/03/2021
Anticipated date of last follow up 20/04/2021
Actual Last follow-up date 14/04/2021
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants)
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group maximum voluntarily contraction 30 sec immediate effect maximum voluntarily isometric contraction is measured for trunk and lower extremity muscle 24 Dose Comparison
Experimental Group quadriped 30 sec immediate effect myo electric activity of trunk and lower extremity muscle are measured 24
Experimental Group bridging 30 sec immediate effect myo electric activity of trunk and lower extremity muscle are measured 24
Experimental Group kneeling 30 sec immediate effect myo electric activity of trunk and lower extremity muscle are measured 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: children with age range from 4-8 years old, diagnosis of congenital spastic cerebral palsy as diagnosed and reported by a medical specialist (i.e. neurologist, pediatrician) ,mild degree of spasticity according to modified Ashworth scale ranging from 1 to 1+ (Bohannon and Smith 1987), children with CP classified as levels I or II of the Gross Motor Function Classification System (GMFCS) and able to follow simple commands. Children with associated neurological or muscloskeletal disorder, surgical procedures or the administration of phenol in the previous 12 months; neurolytic block in the previous six months; cognitive or visual impairment that could interfere with the performance of the procedures. Child: 6 Year-12 Year 6 Year(s) 12 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 05/12/2020 Research ethical committee faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 Ahmedelzayat street Dokki Giza Cairo 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome myo electric activity of trunk muscle 30 seconds
Primary Outcome myoelectric activity of lower extremity muscle 30 seconds
Secondary Outcome best rehabilitation exercise 45 min for each child
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Cairo university 7 Ahmed Elzayat, Giza Governorate Giza 8655 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mona Nabil Ayad Nasr city Cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university 7 Ahmedelzayat street Dokki Giza Cairo 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Samir Elfakharany Dokki Cairo 12511 Egypt
Amal Elborady dokki Giza 12511 Egypt
Reham Ebrahim mohammed Dokki Cairo 12311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Ayad dr_mona_ayad@cu.edu.eg 01011669150 Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Lecturer of pediatric physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Elfakharany drelffakharany@yahoo.com 0201067904792 Dokki
City Postal code Country Position/Affiliation
Cairo 12511 Egypt Lecturer of pediatric physical therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Mona Ayad dr_mona_ayad@cu.edu.eg 0201011669150 Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Lecturer of pediatric physical therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual patient data will be shared No Informed Consent Form,Study Protocol 3 months after publication and for 18 month researchers who provide methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available now 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