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.: PACTR202006588037172 Date of Approval: 17/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy Of Visual Perceptual Training on Trunk stability and mobility In Children With Spastic Cerebral Palsy
Official scientific title Efficacy Of Visual Perceptual Training on Trunk stability and mobility In Children With Spastic Cerebral Palsy
Brief summary describing the background and objectives of the trial sensory integration therapy is child-directed therapy delivered by trained clinician to develop sensory needs and motor abilities which involves the use of multi-sensory environment to provide specific sensory input and through repetition the child brain begin to process sensory stimulation and begins to interact effectively with in sensory environment. The study purpose is to determine the effect of visual perceptual training on trunk stability and mobility in children with spastic 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 01/06/2020
Actual trial start date
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional therapeutic exercise program 60 minute of traditional therapeutic exercise program for each session / three time per week three successive months different functional training exercises, motor learning, postural training exercise to improve trunk control 15 Active-Treatment of Control Group
Experimental Group visual perceptual training program 60 minute of visual perceptual training program in addition to traditional therapeutic exercise program for each session / three time per week three successive months The same previous program for the control group in addition to specific visual perceptual training program within the sensory room 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Their chronological age ranged from five to eight years. • Their functional levels between II to IV according to GMFCS. • Their spasticity graded with 1 to 1+ according to modified Ashowrth scale. • All cases were medically stable. • They can follow simple orders according to their ages. • Visual impairment. • Visual perceptual disorders. • Contractures or fixed deformities in (trunk, thigh or upper limb) • Epileptic fits. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 8 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
No 17/05/2020 Faculty of Physical Therapy Research Ethics Officer
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome trunk stability before and after three successive months of treatment program
Secondary Outcome trunk mobility before and after three successive months of treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Modern University for Technology and Information El-Moustashar Mohammed Mostafa, Al Abageyah, Qism El-Khalifa, Cairo Governorate cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Modern University for Technology and Information El-Moustashar Mohammed Mostafa, Al Abageyah, Qism El-Khalifa, Cairo Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Modern University for Technology and Information El-Moustashar Mohammed Mostafa, Al Abageyah, Qism El-Khalifa, Cairo CAIRO Egypt University
COLLABORATORS
Name Street address City Postal code Country
Marian Magdy Shafeek El-Haram street Giza Egypt
Sara Samir Saadeldien Dokki street Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marian Shafeek Marian.magdy2001@gmail.com +2701224037904 El-Haram street
City Postal code Country Position/Affiliation
Giza Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Sara Samir Sarasamir_karma@outlook.com +2701223425056 Dokki street
City Postal code Country Position/Affiliation
Giza Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Marian Shafeek Marian.magdy2001@gmail.com +2701224037904 El-Haram street
City Postal code Country Position/Affiliation
Giza Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data under lie the results reported in this article ( tables,figures) Statistical Analysis Plan,Study Protocol one year after publication controlled access through authors mails
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