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.: PACTR202208807237148 Date of Approval: 22/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title INFLUENCE OF USING STANDING FRAME WITH TIME VARIATIONS ON LOCOMOTIVE ABILITIES AND QUALITY OF LIFE IN NON AMBULANT SPASTIC CEREBRAL PALSY
Official scientific title INFLUENCE OF USING STANDING FRAME WITH TIME VARIATIONS ON LOCOMOTIVE ABILITIES AND QUALITY OF LIFE IN NON AMBULANT SPASTIC CEREBRAL PALSY
Brief summary describing the background and objectives of the trial Since muscle weakness is a common disorder in children with CP, muscle strength may influence motor performance which affects activity in daily life and develops functional activities (Ozal, 2016). Progressive muscle strength with spasticity interferes with motor rehabilitation (Fernandes et al., 2012). Weight bearing standing exercise is widely used in rehabilitation programs and may enhance functional abilities, increase bone mineral density (BMD) and prevent or minimize musculoskeletal problems (Gudjonsdottir and Stemmons, 2002). However, further studies with a larger cohort and longer follow-up period are required to reveal further information on the benefit of weight bearing exercise and to develop a detailed program (Eun Young et al., 2017). As reported in recent systemic reviews, Bush et al., (2010) and Fehlings et al., (2012) who demonstrated limited and conflicting evidence for using standing frame benefit with respect to body structure and function. But the most recent review Paleg et al., (2013) documented, positive effect of using standing frame with variable duration on BMD, hip stability, and ROM at the hip, knee and ankle. Also, Gericke, (2006), was supported standing frame use as part of postural management for children who were non-ambulant (level IV and V on Gross Motor Function Classification System (GMFCS)) There for, This study is a trial to investigate the effect of different period of time of using standing frame on strength, balance, Functional ability and quality of life in non-ambulant spastic cerebral palsy so, the child become active and improving his self image.
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 01/09/2022
Actual trial start date 07/09/2022
Anticipated date of last follow up 02/09/2023
Actual Last follow-up date 09/09/2023
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 66
Recruitment status Closed to recruitment,follow-up continuing
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
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standing exercise program 3 times per week one hour Twenty two children will receive standing exercise program 3 times per week and using standing frame for one hour daily. 22 Active-Treatment of Control Group
Experimental Group standing exercise program 3 times per week three hour Twenty two children receive standing exercise 3 times per week and using standing frame for three interupted hours daily. 22
Experimental Group standing exercise program 3times per week 5 interrupted hours daily Twenty two children receive standing exercise 3times per week and using standing frame for 5 interrupted hours daily. They will be re-evaluated after 3 months of treatment then after 6 months. 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• They will have cerebral palsy in form of spastic diplegia or quadriplegia. • They will have spasticity ranged from grade 1+ to 2 according to modified Ashworth scale. • They will be able to understand and follow commands and instruction during assessment and treatment. • They are non-ambulant. • Fixed deformity of upper or lower limbs. • Contractures. • Surgical intervention in the lower limb (tenotomy or tendon release). • Botilinum toxin A injection in lower limb in the last six months • Visual or auditory defect. • Cardiovascular or respiratory defect. • Severe mental retardation. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 5 Year(s) 15 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 21/06/2022 Faculty of Physical Theray Cairo University Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Al Zayat Giza 0003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Gross motor functional 2. Growth Motor Function Measure 3. Pediatric Balance 12 month
Secondary Outcome hand held dynamometer, Quality of life 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital Gharbia city. in Gharbia city. 0004 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Radwa Saeid Abdulrahman Azayat Giza 0003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University Al zayat Giza 0003 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Marwa Gamal Al zayat Giza 0003 Egypt
Elham Elsayed Salem Al Zayat Giza 0003 Egypt
Radwa Saeid Abdulrahman Mahmoud Al Zayat Giza 0003 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Gamal Gamal merogamal1988@gmail.com 00201015830092 Al zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Msc in Pediatrics
Role Name Email Phone Street address
Public Enquiries Radwa Saeid Abdulrahman Mahmoud radwakku@gmail.com 00201027713662 Al zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Assistant Professor of Pediatrics
Role Name Email Phone Street address
Scientific Enquiries Elham Esayed Salem Salem dr_elham_salem@hotmail.com 00201001002417 Al zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Professor of Pediatric
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Here by we the authors of this work are obligated to share data and obtained results soon as this work is finished Statistical Analysis Plan 12 months A third Party will be responsible for the data sharing
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet published 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