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.: PACTR201611001888975 Date of Approval: 26/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title effect of footwear modification on postural symmetry and body balance in leg length discrepancy
Official scientific title effect of footwear modification on postural symmetry and body balance in leg length discrepancy
Brief summary describing the background and objectives of the trial leg length discrepancy (LLD) is a frequent phenomenon that is observed in 3-15% of the population.There are enormous effects for LLD on gait and running mechanics standing posture, postural sway,and body balance. it causes a variety of overuse injuries as it alters the magnitude and distribution of mechanical stress within the body. So, this study is designed to investigate the effects of LLD correction on the frontal and transverse plane spino-pelvic alignment (pelvic tilt, trunk imbalance, surface rotation, pelvic torsion and lateral deviation), Oswestry disability index (ODI) score, and Star excursion balance test (SEBT) score in patients with structural LLD pre,and eight weeks post wearing the corrective insole.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LLD ODI SEBT
Disease(s) or condition(s) being studied patients with leg length discrepancy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/08/2015
Actual trial start date 18/08/2015
Anticipated date of last follow up 03/11/2016
Actual Last follow-up date 10/11/2016
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 31
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ethical committe of faculty of physical therapy- cairo university P.T.REC/012/00809
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 randomisation by using coin-tosing Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group corrective custom made insole the patient is asked to wear the insole as long as he stands or walks two months corrective insole with height equivalent to the amount of discrepancy 16
Control Group ordinary shoes as he stands or walks two months patient is asked to wear his ordinary shoes as he stands or walks 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients with structural LLD. 2- LLD with a difference of 5 up to 20mm detected by CT scanogram. 3- Age ranging from 20 to 50 years. 1- Obesity with a body mass index >35 kg/m2, which could impede the automatic detection of the anatomical landmarks by the measuring system. 2- Pelvic obliquity due to functional LLD. 3- Serious medical condition which may affect the patient¿s ability to perform the dynamic balance test (e.g. disc problems, sever osteoarthritis in the vertebral column, ankle sprain, knee instability). 4- Multiple traumas (e.g. post road collision). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 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 01/03/2015 ethical committe of faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 ahmed ezzayat street bien essarayat Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pelvic tilt, pelvic torsion, surface rotation, lateral deviation,SEBT score for the short and long leg, ODI score all parameters are measured pre wearing the insole two months post wearing the insole
Secondary Outcome lordotic and kyphotic angles all parameters are measured pre and two months post wearing the insole
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
clinic of faculty of physical therapy, cairo university 7 ahmed ezzayat street bien essarayat,Giza. Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university cairo university street Giza 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university cairo university street Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Osama Ragaa Abd El Raouf 7 ahmed ezzayat street bien essarayat,Giza. Giza 12612 Egypt
Amira Abdallah Abd El Megeid 7 ahmed ezzayat street bien essarayat,Giza. Giza 12612 Egypt
Radwa Eid Sweif 7 ahmed ezzayat street bien essarayat,Giza. Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reda Ashour redaashour82@yahoo.com 36717691 7 ahmed ezzayat street bien essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Reda Ashour redaashour82@yahoo.com 36717691 7 ahmed ezzayat street bien essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Reda Ashour redaashour82@yahoo.com 36717691 7 ahmed ezzayat street bien essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt assistant lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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