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.: PACTR201711002727159 Date of Approval: 28/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Postural control in chronic ankle instability
Official scientific title Functional static and dynamic balance in females with chronic ankle instability
Brief summary describing the background and objectives of the trial Chronic ankle instability (CAI) is a common sequelae of ankle sprain, affecting an average of 32±9% of patients with symptoms including sensations of giving way, subsequent sprains, and instability. Despite the high prevalence of CAI, it remains a phenomenon that is poorly understood by researchers and clinicians. Conservative treatment of CAI is currently accepted as the primary means of managing the condition and preventing reinjury. In addition, There is insufficient evidence to advocate the prioritization of one exercise over another, or to select the most effective components of a rehabilitation program.so the aim of the study is to compare between different balance training programs in females with CAI. ¿ PURPOSE: ¿ To evaluate the effect of Weight-bearing Exercise for Better Balance (WEBB) program on static and dynamic balance in females with CAI. ¿ To evaluate the effect of unilateral balance training exercises on static and dynamic balance in females with CAI. ¿ To compare between WEBB program and unilateral balance training exercises in females with CAI.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CAI COG NMC
Disease(s) or condition(s) being studied Chronic ankle instability,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 29/10/2017
Actual trial start date 29/10/2017
Anticipated date of last follow up 02/12/2017
Actual Last follow-up date 02/12/2017
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC/012/001609 Ethical committee 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 Randomised statistical random tables simple random allocation by statistical random tables Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group different balance training programs 3 times/week one month WEBB program(consists of a warm-up exercise, standing with a decreased base exercise, graded reaching in standing, and walking practice) 15 Placebo
Experimental Group balance training program 2times/week one month Unilateral balance training(consisit of Single legged Stance,thera band excercisese,wobble board,anterior hop, quadrant hop,toe touch down, single leg ball catch,Hops ups and down) 15
Control Group no intervention 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-A history of at least one significant ankle sprain. 2-The initial sprain must have occurred at least 12 months prior to study enrollment. 3-The most recent injury must have occurred more than three months prior to study enrollment. (unassisted walking without limping for at least three months after injury). 4-A history of the previously injured ankle joint giving way, recurrent sprain and/or feelings of instability. 5-The injured/unstable ankle functionally weaker, more painful, looser, and less functional than the uninvolved ankle. 1-A history of previous surgeries or fractures in either limb of the lower extremity. 2-Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity. 3-Any positive ¿ndings on an anterior drawer or talar tilt test. 4-Balance deficits due to vestibular disorders, such as vertebrobasilar insufficiency and visual disorders. 18 Year(s) 30 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 30/04/2017 ethical committee of faculty of Physical Therapy Cairo University
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 dynamic balance pre-post one month
Secondary Outcome functional static and dynamic balance pre-post one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University 7 Ahmed Ezzayat street, Bien Essarayat Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding sources
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor noha mahmoud youssef 7 Ahmed Ezzayat street, Bien Essarayat Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Salam Mohamed El-Hafez 7 Ahmed Ezzayat street, Bien Essarayat Giza 12612 Egypt
. Azza Mohammed Abd El-Mohsen 7 Ahmed Ezzayat street, Bien Essarayat Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noha mahmoud nohamahmoud55555@gmail.com 37617692 7Ahmed Ezzayat street, Bien Essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt demonstrator
Role Name Email Phone Street address
Public Enquiries Salam El-Hafez egyptsalam@yahoo.co.uk 37617691 7 Ahmed Ezzayat street,Bien Essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt Prof
Role Name Email Phone Street address
Scientific Enquiries noha mahmoud nohamahmoud55555@gmail.com 37617692 7Ahmed Ezzayat street, Bien Essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt demonstrator
Role Name Email Phone Street address
Scientific Enquiries Azza Abdelmohsen dr_azzamohammed@yahoo.com 37617691 7 Ahmed Ezzayat street,Bien Essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt Teacher
REPORTING
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