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.: PACTR202105604636415 Date of Approval: 21/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Correlation between selective motor control of lower extremities and balance in spastic hemiplegic cerebral palsy: A Randomized Controlled Trial
Official scientific title Correlation between selective motor control of lower extremities and balance in spastic hemiplegic cerebral palsy: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial To investigate the correlation between selective motor control of lower extremities and balance in spastic hemiplegic 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 01/12/2018
Actual trial start date 01/12/2018
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date 31/08/2020
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Neurodevelopmental technique with fine motor training for affected side total treatment time was 90 minutes., 3 sessions/ week six months a guideline protocol that was based on neurodevelopment basis that was included; standing on one foot, stride standing allowing weight shift from one limb to another, standing on balance board, stoop and recovery from standing position, balancing exercises from standing in the form of equilibrium, righting and protective reactions training, improving trunk control, balance training exercises, gait training exercises in an open environment and stretching exercises for elbow flexors and forearm supinator of upper limbs, hip flexors, and adductors, hamstrings and calf muscles of lower limbs 15 Active-Treatment of Control Group
Experimental Group mirror therapy intervention total treatment time was 90 minutes., 3 sessions/ week. for six months the same guideline protocol which was given to the control group for 60 minutes in addition to motor training for non-affected side while received mirror visual feedback from non-affected lower limb 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children were diagnosed as having unilateral CP based on careful clinical assessment by a physiotherapist,they had mild to moderate spasticity according to the Modified Ashworth Scale, they were stable medically and psychologically, they were able to follow verbal commands or instructions children who had any visual or auditory problems, children that had a history of epilepsy, children with fixed deformities in upper limb that interfere with gross motor functions, children with a history of any surgical interference in lower limbs for less than one year, Child: 6 Year-12 Year 6 Year(s) 9 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 07/02/2021 ethics committee FACULTY OF PHYSICAL THERAPY Cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of selective motor control for lower extremities by Selective Control Assessment of Lower Extremity (SCALE) All outcomes were measured at the baseline and the end of the interventions.
Secondary Outcome Assessment of balance by Pediatric Balance Scale (PBS) were conducted All outcomes were measured at the baseline and the end of the interventions.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Misr University for Science and Technology 6 October Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amira Hussin Mohammed 69 Alkasr Alani street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amira Hussin Mohammed Cairo Cairo 11562 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Samah Mahmoud Ahmed Sheha October Giza 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Amira Mohammed amira_hussin77@yahoo.com +2001144495063 Cairo
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Delta University for science and technology
Role Name Email Phone Street address
Principal Investigator Amira Mohammed amira_hussin77@yahoo.com 002001144495063 Cairo
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Delta University for science and technology
Role Name Email Phone Street address
Public Enquiries Samah sheha Samah.sheha@must.edu.eg 002001202555405 October
City Postal code Country Position/Affiliation
Giza 11432 Egypt Misr University for science and technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be shared at 1st DEcember 2021 Clinical Study Report,Informed Consent Form,Statistical Analysis Plan 1st December 2021 demographic data, Pre and post interventions measurable data, tables and figures
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