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.: PACTR201911599932399 Date of Registration: 06/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Additional Ankle Weight in Improving Knee Extension
Official scientific title Additional Ankle Weight in Improving Knee Extension in Children with Cerebral Palsy. Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Knee extensors weakness is a problem in spastic diaplegic CP, studies revealed effects of strength training and relationship of muscle power with activity in children with CP Objective: This study was conducted to investigate the effect of using ankle weight in gait training on knee extensor strength in diaplegic CP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AAWIKECCP
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 03/04/2019
Actual trial start date 24/04/2019
Anticipated date of last follow up 30/10/2019
Actual Last follow-up date 20/11/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 52
Recruitment status Completed
Publication URL not available
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 Received a selected therapeutic program 20min Daily for six months Gait training open environment 15 Active-Treatment of Control Group
Experimental Group additional ankle weight during gait training 20 Six month same treatment given to control plus additional weight to ankle joint during gait training 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 5-7 years of age. Gender: Male and female. Level of gross motor function classification system ranged from I-III. According to GMFCS. Degree of spasticity extended from 1-1+ as indicated by Modified Ashworth Scale. Children had the option to pursue and comprehend verbal direction with an IQ level over 80%. Children aged more than 7 years of age and less than 5 years of age. Other diagnosis as delayed milestone, genetic disorders, metabolic disorders and brain tumors. Any previous history of orthopedic intercessions, botulinum poison infusion to the lower limbs inside in recently to a month, past lower appendage medical procedure. Child: 6 Year-12 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 29/09/2019 Faculty of Physical Therapy Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayat Giza 0003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improving muscle strength of knee extension within 3-6month
Secondary Outcome Improvement of gross motor function (GMFM-88) portion D&E 3-6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University 7 Ahmed El zayat Giza 0003 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Radwa Saeid Abdulrahman Mahmoud 21 Sheikh Zayed Giza 0003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy 7 Ahmed El Zayat Giza 0003 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Radwa Saeid Abdulrahman 7th Al Zayat Giza 0003 Egypt
Shaimaa Abdalaleem Abdalgaleel Kasr el Einy Cairo 0002 Egypt
Nadia lotfy Radwan sattam Alkharej 00966 Egypt
Islam Mahmoud AlAzab 7th Al Zayat Giza 0003 Egypt
Nabil Mahmoud Abdel Al 7th Al zayat Giza 0003 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Radwa Saeid Abdulrahman Mahmoud radwakku@gmail.com 00201027713662 21 sheikh Zayed
City Postal code Country Position/Affiliation
Giza 0003 Egypt lecturer in department of physical therapy in pediatrics
Role Name Email Phone Street address
Public Enquiries Khaled Ahmed Olama k_olama@hotmail.com 00201110222235 Banafseg 3 - 5th settlement
City Postal code Country Position/Affiliation
Cairo 0002 Egypt Professor in department of physical therapy in pediatrics
Role Name Email Phone Street address
Scientific Enquiries hala kassem halakassem146@gmail.com 00201143686666 5 th settlement
City Postal code Country Position/Affiliation
Cairo 0002 Egypt Professor in department of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes here by me and all the participants and as well as the patients approve sharing results within 18 month of completion of the study . Informed Consent Form,Statistical Analysis Plan within 48 months cause till now not published controlled, a third party will decide after requirements review
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable not published yet Yes 06/06/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 06/06/2021 Result - 06/06/2021 Result - 06/06/2021 Result - 06/06/2021 Result - 06/06/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information