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.: PACTR202102774278414 Date of Approval: 17/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Task-orientated Circuit Training on Gait Kinematics, Pelvic Symmetry and Endurance in Children with Hemiplegia
Official scientific title Effect of Task-orientated Circuit Training on Gait Kinematics, Pelvic Symmetry and Endurance in Children with Hemiplegia
Brief summary describing the background and objectives of the trial This study aims to:  Investigate the effect of exercise-based task-oriented circuit training on gait kinematics including (Stride length, step length, cadence, walking speed, ankle dorsiflexion angle in initial contact, knee extension angle in midstance and hip extension angle in terminal stance) in children with hemiplegic CP.  Determine the effect of task-oriented circuit training on pelvic symmetry including (Anterior and lateral pelvic tilting) in children with hemiplegic CP.  Examine the effect of task-oriented circuit training on trunk endurance including (prone plank test, timed partial curl up test, front abdominal power test and unilateral supine bridge test) in children with hemiplegic CP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2021
Actual trial start date
Anticipated date of last follow up 01/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Specially designed Physical Therapy program for 90 minutes, 3 times/week for 3 successive months -Facilitation of balance reactions from standing position including; standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, and standing on balance board. -Facilitation of counterpoising mechanism through instructing the child to kickball from standing position as well as catching and throwing the ball with his hands. -Gait training activities including walking using different obstacles (rolls, wedges, stepper) and walking up and downstairs. -Facilitation of protective reaction from standing position by pushing the child in different directions. -Facilitation of rising mechanism through changing position as well as returning back to the original position e.g.: from lying to standing and from sitting to standing. -Strengthening exercises for back and abdominal muscles as well as upper and lower limbs. -Jumping in place and jumping aboard. 20 Active-Treatment of Control Group
Experimental Group Task oriented circuit training Children allocated to the study group will receive the same selected physical therapy program given to the control group for 45 minutes in addition to 45 minutes task-oriented circuit training program. The frequency of the whole program will be three times per week, for three months. The task-oriented circuit training program consisted of 14 workstations. Time spent at each station will be 1.5 minutes. The children will complete the activity at one station and move to another station. The whole circuit will be completed in 21 minutes and it will be repeated twice per session with 3 minutes rest interval between the 2 circuits. Children will be encouraged to work as hard as possible at each workstation and will also be given verbal feedback and instructions aimed at improving performance. The progression of the task will be considered according to each child’s ability and progressed as tolerated. Progressions include increasing the number of repetitions and increasing complexity of the exercise performed at each workstation, such as the distance reached in standing, reducing the height of the chair during sit-to stand, changing the height of blocks or by increasing speed of movement. Warm-up and cool-down will be performed before and after exercise, respectively in the form of stretching and light activity exercises 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Their age will be ranged from 7-10 years. - Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008). - The degree of spasticity will range from mild to moderate according to Modified Ashworth Scale (Bohannon and Smith, 1987). - They will be able to follow instructions during evaluation and treatment. Children will be excluded from the study if they have: - Other types of cerebral palsy. - Cardiovascular or respiratory disorders. - Botulinium muscular injection in the last 6 months - Surgical interference in lower limbs and/or spine. - Muscloskeletal problems or fixed deformities in the spine and/or lower extremities. - seizures. - Visual or hearing impairment. 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 05/01/2021 Research Ethics committee Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayyat Dokki Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Kinematic parameters of gait will be calculated by using 2D gait analysis by Kinovea software in order to measure angles of hip, knee and ankle during subphases of gait cycle. Also, Spatiotemporal parameters will be measured which include step length, stride length, walking speed and cadence. At baseline and after 3 months of intervention.
Primary Outcome Pelvic symmetry will be measured by using a Palpation meter inclinometer in order to measure anterior and lateral pelvic tilting. at baseline and after 3 months on intervention
Secondary Outcome Endurance of the trunk muscles will be evaluated using four endurance tests designed to establish the isometric trunk muscles endurance including; prone plank test, timed partial curl-up test, front abdominal power test, and unilateral supine bridge test. A stop watch was used to record the time a child can maintain the test position. at baseline and after 3 months of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic Faculty of Physical Therapy Cairo University 7 Ahmed Elzayyat Dokki Giza 12316 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Salah ElSayed 13 Alquds street Mubarak city Mansoura Dakahlya 35111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University 7 Ahmed Elzayyat Dokki Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Samah Attia El Shemy 7 Ahmed Elzayyat Dokki Giza 12613 Egypt
Ayman Mohamed Kilany 7 Ahmed ELzayyat Dokki Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Salah ElSayed Awad melsayed@horus.edu.eg +201017173755 13 AlQuds street mubarak city
City Postal code Country Position/Affiliation
Mansoura Dakahlya 35111 Egypt Assistant Lecturer of Pediatric Physical Therapy Faculty of Physical Therapy Horus University Egypt
Role Name Email Phone Street address
Public Enquiries Samah Attia El shemy samah_elshemy@yahoo.com +201005014313 7 Ahmed Elzayyat
City Postal code Country Position/Affiliation
Dokki Giza 12613 Egypt Professor of Pediatric Physical Therapy Faculty of Physical Therapy Cairo University Egypt
Role Name Email Phone Street address
Scientific Enquiries Ayman Mohamed Kilany elkilany7000@gmail.com +201003842224 7 Ahmed Elzayyat
City Postal code Country Position/Affiliation
Dokki Giza 12613 Egypt Assistant professor of Neurology National research center Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after identification. Immediately following publication, No end date. Kinematic gait parameters anterior and lateral pelvic tilting angles trunk muscle endurance tests' score Informed Consent Form,Statistical Analysis Plan,Study Protocol within 2 years of publication of the primary outcomes of the study. Using of controlled access approach with systems in place to review data access requests for the medical community. The study protocol, statistical analysis plan, consent form, result raw data will be available. Reviewers should be qualified in Physical therapy and rehabilitation.
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 - 09/02/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information