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.: PACTR202011595776564 Date of Approval: 18/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of two orthoses on balance in diplegic CP
Official scientific title Long term effect of ankle foot orthosis versus ground reaction ankle foot orthosis on balance in children with diplegic cerebral palsy.
Brief summary describing the background and objectives of the trial The children with diplegic CP commonly have croutch while standing and flexed knee posture while walking affecting their abilities of keeping balance from standing and walking efficiently. Many approaches can be used to target this problem in these children either surgery, physical therapy or splinting.Orthoses are one of these approaches that can be prescribed to provide stabilization of lower limbs joints that improve balance and walking in diplegic children. Purpose: This study was conducted to assess the long term effect of solid ankle foot orthosis (AFO) versus the ground reaction ankle foot orthosis (GRAFO) on balance in children with diplegic 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 08/01/2020
Actual trial start date 08/01/2020
Anticipated date of last follow up 18/03/2020
Actual Last follow-up date 18/03/2020
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
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 Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group the first study group A; received the regular physical therapy program besides wearing the AFO. Physical therapy was conducted 3 sessions/week , while the AFO was worn as long as the child is awake. Successive 3 months Physical therapy program based on neurodevelopmental therapy for these children, while the AFO was custom molded on a negative cast model for each child. 15
Experimental Group The GRAFO Group. Physical therapy program was conduced 3 sessions/week, while the GRAFO was worn as long as the child is awake. Successive 3 months. The physical therapy program based on neuro-developmental therapy for these children, while the GRAFO was custom molded on a negative cast model for each child. 15
Control Group NDT program 3 sessions/week for one hour 3 successive months. based on the NDT for these children. 0 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Both genders participated in this study, They were selected from out- patient clinic, Faculty of Physical Therapy, Cairo University, Their ages were between 6-9 years chronologically, Their spasticity ranged from 1 to 1+ according to modified Ashwarth scale. Had no history of surgical interference at least during the last 6 months Their heights were at least one meter to be able to see the screen of Biodex balance system. Children having convulsions or fixed deformities in the lower limbs. Child: 6 Year-12 Year 6 Year(s) 9 Year(s) Both
Both genders participated in this study, They were selected from out- patient clinic, Faculty of Physical Therapy, Cairo University, Their ages were between 6-9 years chronologically, Their spasticity ranged from 1 to 1+ according to modified Ashwarth scale. Had no history of surgical interference at least during the last 6 months Their heights were at least one meter to be able to see the screen of Biodex balance system. Children having convulsions or fixed deformities in the lower limbs. 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 26/11/2019 Research Ethical Committe. Faculty of Physical Therapy. Cairo University
Ethics Committee Address
Street address City Postal code Country
Ahmed ElZayat, Dokki Giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The antero-posterior stability index Degrees
Secondary Outcome The Medio-lateral stability index Degrees
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic Faculty of Physical Therapy Cairo University Ahmed ElZayat, Dokki Giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Doaa Ahmed Sanad Ahmed ElZayat Giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Doaa Ahmed Sanad Ahmed ElZayat Giza 12511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa Sanad dr.doaa.sanad@gmail.com +201007206392 Ahmed ElZayat
City Postal code Country Position/Affiliation
Giza 12511 Egypt Lecturer Pediatric Physical Therapt Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Doaa Sanad dr.doaa.sanad@gmail.com +201007206392 Ahmed ElZayat
City Postal code Country Position/Affiliation
Giza 12511 Egypt Lecturer Pediatric Physical Therapt Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Doaa Sanad dr.doaa.sanad@gmail.com +201007206392 Ahmed ElZayat
City Postal code Country Position/Affiliation
Giza 12511 Egypt Lecturer Pediatric Physical Therapt Department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No patient data will be shared. Statistical Analysis Plan,Study Protocol N/A N/A
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