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.: PACTR201611001835280 Date of Approval: 26/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Alignment and proprioception in females
Official scientific title Lower extremity alignment and proprioception in females with anterior pelvic tilt
Brief summary describing the background and objectives of the trial Alignment of lower extremity has been proposed as risk factor for several acute and chronic lower extremity injuries. Pelvic alignment is recognized as the cornerstone of overall skeletal alignment.little is known about the effect of anterior pelvic tilt on lower extremity alignment and proprioception. So, the purpose of this study is to establish the effect of anterior pelvic tilt on lower extremity proprioception and alignment in healthy female individuals
Type of trial CCT
Acronym (If the trial has an acronym then please provide) LEA lower extremity.
Disease(s) or condition(s) being studied anterior pelvic tilt
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/08/2016
Actual trial start date 30/10/2016
Anticipated date of last follow up 01/04/2017
Actual Last follow-up date 01/04/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL 012/001326
Secondary Ids Issuing authority/Trial register
ethical commitee of faculty of physical therapy cairo university
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 Non-randomised convenient sample Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised convenient sample Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group pelvic assessment one shot one shot assessment of pelvic tilt then allocating sample into 3 groups according to degree of pelvic tilt 30
Control Group pelvic assessment one shot one shot assessment of pelvic tilt then allocating sample into 3 groups according to degree of pelvic tilt 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Study group: ¿ Having anterior pelvic tilt ranging between four to twelve degrees. ¿ Having anterior innominate rotation ranging between one to four degrees Control group: ¿ Having normal pelvis (pelvic tilt less than three degrees). ¿ Having symmetrical pelvis (bilateral difference less than one). ¿ Having any lower limb or back injuries ¿ Having any previous history that would affect the alignment or the motion to lower extremity joints as fractures or surgery. ¿ Having fixed deformity or low back pain 18 Year(s) 25 Year(s) Female
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 05/06/2016 Ethical Commitee of Faculty of Physical Therapy
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Ezzayat street, Bein Esarayat Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome alignment of lower extremity one shot
Secondary Outcome knee proprioception one shot
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university 7 Ahmed Ezzayat street, Bein Essarayat Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source
no funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy 7 Ahmed Ezzayat street, Bein Essarayat Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Salam El Hafez 7 Ahmed Ezzayat street, Bein Essarayat Giza 12612 Egypt
Abeer Farag 7 Ahmed Ezzayat street, Bein Essarayat Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noha Khaled nohakhaled555@gmail.com 01008034354 7 Ahmed Ezzayat street, Bein Esarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt demonstrator
Role Name Email Phone Street address
Public Enquiries Noha Khaled nohakhaled555@gmail.com 01008034354 7 Ahmed Ezzayat street, Bein Esarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt demonstrator
Role Name Email Phone Street address
Scientific Enquiries Noha Khaled nohakhaled555@gmail.com 01008034354 7 Ahmed Ezzayat street, Bein Esarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt demonstrator
REPORTING
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