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.: PACTR202304816093190 Date of Approval: 18/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The efficacy of whole-body vibration on the degree of toe angle and its correlation to knee osteoarthritis index among female university students during level walking
Official scientific title The efficacy of whole-body vibration on the degree of toe angle and its correlation to knee osteoarthritis index among female university students during level walking
Brief summary describing the background and objectives of the trial Whole-body vibration (WBV) training is one of the methods used for ankle rehabilitation as it has an oscillating vibration platform, which stimulates muscle spindles to excite tonic vibration reflex. It has been shown to improve neuromuscular performance in healthy individuals. The aim is to determine the impact of whole-body vibration (WBV) on the degree of toe angle besides the correlation between the toe angle and knee osteoarthritis index among female university students during level walking.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/01/2023
Actual trial start date 05/01/2023
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date 27/02/2023
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Whole body vibration six weeks Whole body vibration (WBV) device Whole body vibration (Power Plate® pro7HC™) with low frequencies ranges from 5 - 15 Hz and an oscillating amplitude (2 mm). Five rehabilitation programs were selected related of the ankle and foot for each selected case with toe in (related to the degree of toe angle). These five sets were per one session, 3 sessions per week and for six weeks, according to the parameter device 30 second for each case was documented. The five-rehabilitation program introduced by this device for ankle and foot were demonstrated as follows 1) Hamstring Stretch, 2) squat matrix “neutral stance”, 3) Dynamic hip movement, 4) squat matrix “Feet Wide facing forward”, 5) hip flexor stretch. 21
Control Group home based exercise six weeks Home based exercise HBE offers five different workout plans. Active range-of-motion, muscle-strengthening, and stretching movements made up the exercise protocol. The ankle and foot muscles' strength, flexibility, and range of motion were to be increased as part of the procedure. Participants were guided to practice the exercise protocol. The majority of the exercises recommended can be adopted into daily life. For instance, individuals were instructed to regularly dorsiflex and evert their ankles while sitting on a chair and progressively straighten each leg out in front of them. Each exercise could be done up to ten times by each person, according to instructions. A thorough handout with instructions and pictures of the exercises was given to each subject. For six weeks, subjects will attend HBE sessions more than three times each week. The subjects were told that no exercise should cause them any pain. 21 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age: 19-21 years old. 2- BMI: 20-24 kg/m2. 3- All participants have a toe-in degree based on data obtained from The GAIT Rite system Participants with previous trauma or surgery in the lower extremities’ joints. were excluded. Adult: 19 Year-44 Year 19 Year(s) 21 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 11/12/2022 ethical committee board approval of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
giza cairo 11511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Each student was asked to walk normally as much as possible using the gait training device GAIT Rite system without target walking, as each student was asked to make three trials barefoot to ensure the normality of the walking pattern. According to spatiotemporal parameters extracted from this device, the positive sign indicated to toe out, and a negative sign indicated to toe in. baseline / six weeks
Secondary Outcome Western Ontario and McMaster osteoarthritis index (WOMAC) was used to assess the functional level of participants to predict osteoarthritis (OA) and its correlation to the degree of toe angle. baseline / six weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Giza Cairo 11511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Princess Nourah bint Abdulrahman University king khaled street Riyadh 11671 Saudi Arabia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university giza cairo 11511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany AbdEtawab aeabdullah@ju.edu.sa 00960541806736 alqaet
City Postal code Country Position/Affiliation
sakaka 2014 Saudi Arabia Physical Therapy and Health Rehabilitation Department Faculty of Applied Medical Sciences Jouf University Biomechanics Department Faculty of Physical Therapy Cairo Univ
Role Name Email Phone Street address
Scientific Enquiries Dalia ELSHERBINI dmelsherbini@ju.edu.sa 00966594488624 alqait
City Postal code Country Position/Affiliation
sakaka 2014 Saudi Arabia Department of Clinical Laboratory Sciences College of Applied Medical Sciences Jouf University
Role Name Email Phone Street address
Public Enquiries Heba GHANEM hbghanem@ju.edu.sa 00966545194017 alqait
City Postal code Country Position/Affiliation
sakaka 2014 Saudi Arabia Department of Clinical Laboratory Sciences College of Applied Medical Sciences Jouf University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol is the document was available. the data will be available from the beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal. the type of analyses in order to achieve aims in the approved proposal. Proposal may be submitted up to 36 months following article publication. Study Protocol six weeks GraphPad Prism version 9 was used to analyze collected data, which presented as mean± SEM. The difference in demographic characteristics among the HBE and HBE+WBV groups was detected by student’s t-test. While to assess outcome variables between the two groups, we used Two-way repeated measures ANOVA. The effect size between-group effect was calculated by partial eta square. Significance was considered when p<0.05. The paired t-test was performed to test the outcome difference within each group. Using a linear regression model with a generalized estimating equations (GEE) correction, the relationship between the degree of toe angle and the WOMAC index in both groups was evaluated at baseline and six weeks after the intervention. Any extremes are eliminated after the data has been standardized. Before using the parametric assumption, the normality and homogeneity of the variance were statistically evaluated
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