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.: PACTR202102915429305 Date of Approval: 09/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of core stability exercises program on walking performance in children with diplegic cerebral palsy; a randomized control study.
Official scientific title Effect of core stability exercises program on walking performance in children with diplegic cerebral palsy; a randomized control study.
Brief summary describing the background and objectives of the trial Background: Children with cerebral palsy have poor axial control which affects their walking capabilities. Although there are limited studies that demonstrate core stability training in cerebral palsy. Objectives: This study was conducted to examine the Effect of core stability exercises program on walking performance in children with diplegic 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 01/09/2020
Actual trial start date 08/09/2020
Anticipated date of last follow up 08/12/2020
Actual Last follow-up date 22/12/2020
Anticipated target sample size (number of participants) 30
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Regular physical therapy program according to the NDT approach. one hour /day , 3 sessions /week for 8 weeks. 3 sessions /week for 8 weeks. The regular Physical therapy program based on the neurodevelopmental techniques to improve physical performance in these children. 15 Active-Treatment of Control Group
Experimental Group Core Stability exercises program 45-60 minutes for 8 weeks 3 sessions/week for 8 weeks. Jeffreys exercise protocol included 3 levels starting with level 1 and gradually progressed to level 3; Level 1 consisted of static contraction training which was done in a stable condition. Level 2 consisted of dynamic training which was done in a stable condition and level 3 consisted of dynamic and resistance training which was done in an unstable condition. Swiss balls were used to create an unstable condition. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Their ages ranged from seven to ten years, Were able to ambulate, They had gait problems. (Lev¬el II or III GMFCS), Had no convulsions, Had no history of surgical interference in the last 6 months, Their heights were 1 meter and more to be able to see the screen and They had abnormal gait kinematics which can be collected from assessment. Children who had any fixed contractures or convulsions Child: 6 Year-12 Year 7 Year(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 18/08/2020 Research Ethical Committe. Faculty of Physical Therapy. Cairo University
Ethics Committee Address
Street address City Postal code Country
Ahmed ElZayat, Dokki Giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Energy Expenditure Index (EEI Before and after the commencement of the study.
Secondary Outcome GMFM scores; walking, running and jumping item Before and after the commencement of the study.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic Faculty of Physical Therapy Cairo University Ahmed ElZayat, Dokki Giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors Ahmed ElZayat Giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Doaa Ahmed Sanad Ahmed ElZayat Giza 12511 Egypt Individual
Secondary Sponsor Amira H. Draz Ahmed ElZayat Giza 12511 Egypt Individual
Secondary Sponsor Rania G. Hegazy Ahmed ElZayat Giza 12511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Doaa Ahmed Sanad Ahmed ElZiat Giza 12511 Egypt
Amira Hussein Draz Ahmed ElZiat Giza 12511 Egypt
Rania Galaudein Abdou Ahmed ElZiat Giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa Sanad dr.doaa.sanad@gmail.com +201007206392 Ahmed ElZayat
City Postal code Country Position/Affiliation
Giza 12511 Egypt Lecturer Pediatric Physical Therapt Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Amira Draz amira.draz@pt.cu.edu.eg +201149411373 Ahmed ElZayat
City Postal code Country Position/Affiliation
Giza 12511 Egypt Professor Basic Science department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Rania Hegazy raniagalal2011@yahoo.com +201027466206 Ahmed ElZayat
City Postal code Country Position/Affiliation
Giza 12511 Egypt Lecturer Pediatric Physical Therapt Department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD in this study will not be shared. Clinical Study Report,Statistical Analysis Plan,Study Protocol N/A N/A
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