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.: PACTR202004808096519 Date of Approval: 17/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Whole Body Vibration Versus BIODEX Balance Training On Patients With Chronic Ankle Instability
Official scientific title Whole Body Vibration Versus BIODEX Balance Training On Patients With Chronic Ankle Instability
Brief summary describing the background and objectives of the trial Traumatic ankle injury represents a significant health care issue . The ankle is the second most commonly injured body parts in sports and lateral ankle sprain (LAS) is the most common musculoskeletal injury among the physically active population, as well as the most prevalent ankle sprain type (85% of all ankle sprains) .LAS are often erroneously thought to be an innocuous injury, when in truth, it represents a significant public health problem because of the joint’s susceptibility to recurrent injury .This study will be conducted t is to determine which type of training (Biodex balance training and Whole body vibration) obtains the best improvement in patients with chronic ankle instability.The purpose of the study is to determine which type of training (Biodex balance training and Whole body vibration) obtains the best improvement in patients with chronic ankle instability on limit of stability and sensory motor integration. It will be conducted in outpatient clinic of faculty of physical therapy Modern University For Technology and Science. Forty five subjects of both gender diagnosed with chronic ankle instability from one year ago .There age ranged from 18-35 years to limit the effect of adolescent growth, and no effects of arthritic changes that developed in ankle or other lower limb joints will be assigned randomly into 3 groups all patients will sign a consent form before starting; they will be randomly allocated into 3 equal groups (each consist of 15 patient).Outcome measures will be measured by Biodex balance system include:Limit of stability and Sensory motor Interaction The assessment will be done before and after treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LAS
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 31/03/2020
Actual trial start date 31/03/2020
Anticipated date of last follow up 01/04/2021
Actual Last follow-up date 01/04/2021
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Not yet recruiting
Publication URL No publication yet
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control group 3 sessions per week four weeks strengthening and stretching exercise. 15 Active-Treatment of Control Group
Experimental Group Whole body vibration Group 3 sessions per week four weeks Whole body vibration plus strengthening and stretching exercise. 15
Experimental Group Biodex balance training group 3 sessions per week four weeks Biodex balance training plus strengthening and stretching exercise. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects with the following criteria will be enrolled in this study: 1) Subjects age between 18-35 years old. 2) Their complain lasts at least one year. 3) Participants body mass index is not more than 30 4) Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others) . 5) Availability to attend the hospital during the treatment and follow up. Patients will be excluded from the study if they have: 1) Neurological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months 2) Pacemaker 3) Recent bone injury, fracture or joint replacement within the past 12 months 4) Previous ankle surgery Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 35 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
No 18/03/2020 Faculty of physical therapy research eithics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El-Zayat Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Limit of stability pre and post treatment
Primary Outcome sensory motor interaction indexes (Sway Index and Stability Index). pre and post treatment
Secondary Outcome Pain Intensity pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Modern and Technology Univeristy El Mokattam Cairo 11571 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo univeristy 7 Ahmed El Zayat Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maha Gamal maha_maha_1234567@yahoo.com 01003922856 El Maadi
City Postal code Country Position/Affiliation
Cairo 11728 Egypt Assistant Lecture of Basic Science Department Modern and Technology Univeristy
Role Name Email Phone Street address
Public Enquiries Ragia Mohamed ragiaamohameed@yahoo.com 01222404923 El Tahrir street ,El Dokii
City Postal code Country Position/Affiliation
Giza 12613 Egypt Professor of Basic Science DepartmentFaculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Amira Draz Amira.draz@pt.cu.edu.com 01149411373 7 Ahmed El Zayat
City Postal code Country Position/Affiliation
Giza 12613 Egypt Assistant professor of Basic Science Department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes It is decided that IPD data will be available for this clinical trial. Data can be shared as study protocol, statistical analysis and results. also informed consent of each patient will be available. All data can be available as soft copies (microsoft word document, excel sheets) provided upon request. Data will be available in a time frame of 12 months from the completion of the study Informed Consent Form 12 months after the completion of the study Access for improving medical research. Data can be reanalyzed,validation or combined with other data for similar studies
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