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.: PACTR202111663993438 Date of Approval: 12/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect Of Functional Progressive Resistance Exercise Versus Eccentric Muscle Control In Children With Hemiplegia: A Randomized Controlled Trial
Official scientific title Functional Progressive Resistance Exercise Versus Eccentric Muscle Control In Children With Hemiplegia
Brief summary describing the background and objectives of the trial A Randomized Controlled Trial aims to compare Effect Of Functional Progressive Resistance Exercise Versus Eccentric Muscle Control On Dynamic Balance And Functional Ability In Children With Hemiplegia
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 15/11/2021
Actual trial start date
Anticipated date of last follow up 15/01/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Active, not recruiting
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Functional Progressive Resistance Exercise 3 days per week 6 weeks Each exercise in this group will be comprised of 5 min of warmup exercise followed by three different types of exercise.  Exercise repetition will be five times in the first two weeks,then increased to 10 times in the subsequent 2 weeks and 15 times in the last two weeks.  More specifically used weight will be increased according to subject’s participation, body weight and exercise repetition will be increased every two weeks by 5%, 10% and 35% based on their body weight. According to each subject’s performance both weight and repetition would be increased.  Three circuit exercises will be included: sit to stand, half-kneeling standing up and side step-up. 16  In the sit to stand exercise, the child will sit on a bench with no back rest. In the starting position, the child’s back, knee and ankle need to be flexed at a 90_ angle and their ankles should be in contact with the floor. From the starting position, the subject will be instructed by the physical therapist to stand up slowly from the bench.  In the half-kneeling standing exercise, the child will sit in a half-kneeling position without any external support. From this starting position, the child will gradually push forward to stand up while the weight is shifted forward on the front leg.  In the side step-up exercise, the child will climb up a 15 cm staircase sideways.  Between each circuit, 30 s to1 min of rest time will be given to subjects. Longer rest times will be given to subjects with lower GMFC Sscores to reduce stress  A cooling down exercise and range of motion stretching will be held in the final 2 min 20
Control Group Eccentric muscle control 3 days per week 6 weeks Exercise Will be conducted from standing and return to sitting on chair slowly to activate eccentric muscle contraction of gluteus maximus and anterior tibial group.  Standing and shift weight anterior slowly (activating first heel rocker and second ankle rocker).  Sitting and return to crock lying gradually.  Standing single limb support and kick large ball backward slowly to specific target on a mirror placed behind child.  Each exercise will be done for 5 times and repeated for 10 set with rest in between sets 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Their age will range from six to thirteen years old. 2-They will be able to understand and follow verbal commands and instructions included in both the test and treatment procedures. 3- Able to participate in a group training programm. 4- Able to walk independently indoors without walking aids GMFCS (gross motor function classification system) level between I and III. 1-Has significant mental or behavioral disorders. 2- Visual or auditory problems. 3- Structural or fixed soft tissue deformities of the lower extremities. 4- Undergone musculoskeletal surgery or botulinum toxin injection in the lower limbs in past six months. 5- Has unstable seizures. 6- suffer from other diseases that interfered with physical activity Child: 6 Year-12 Year 6 Year(s) 13 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 26/04/2021 Ethics committee physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed EL Zayat street-Been EL-Saryat-dokki giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gross Motor Function Classification System expanded and revised to assess the child’s functional abilities baseline
Primary Outcome Height, weight, BMI to apply the appropriate amount of weight for each intervention baseline
Primary Outcome Gross Motor Function Measure-88 to assess the child’s motor performance baseline
Primary Outcome functional reach test to assess dynamic balance baseline
Secondary Outcome - Gross Motor Function Measure-88 to evaluate improvement in functional ability of the child after 6 weeks
Secondary Outcome functional reach test to evaluate improvement in dynamic balance after 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patients clinic Physical Therapy College Cairo University 7 Ahmed EL Zayat street-Been EL-Saryat-dokki Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Yosra Magdy 7 Ahmed EL Zayad street-Been EL Saryat-dokki Giza 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Yosra Magdy 7 Ahmed EL Zayad street-Been EL Saryat-dokki Giza 11432 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amira Mohamed ELTohamy 7 Ahmed EL Zayad street-Been EL Saryat-dokki Giza 11432 Egypt
Mona Nabil Ayad 7 Ahmed EL Zayad street-Been EL Saryat-dokki Giza 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amira ELTohamy amiraeltohamy229@gamil.com +201001662350 7 Ahmed EL Zayad street-Been EL Saryat-dokki
City Postal code Country Position/Affiliation
Giza 11432 Egypt Professor of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mona Ayad dr_mona_ayad@cu.edu.eg +201011669150 7 Ahmed EL Zayad street-Been EL Saryat-dokki
City Postal code Country Position/Affiliation
Giza 11432 Egypt Lecturer of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Yosra Magdy yosramagdy868@gamil.com +201116085030 7 Ahmed EL Zayad street-Been EL Saryat-dokki
City Postal code Country Position/Affiliation
Giza 11432 Egypt Bachelor of Physical Therapy
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 avaliable 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