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.: PACTR201512001369361 Date of Approval: 28/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Wiihabilitation affects muscle strength
Official scientific title Effect of wiihabilitation on strength ratio of ankle muscles in adullt
Brief summary describing the background and objectives of the trial Wiihabilitation is a novel rehabilitation technology that provides clinicans with low cost, feasible and entertaining modality. Ankle instability is common consequence after ankle sprain that affects athletes and sedentary people daily life and activities. Therefore, investigating the effect of wii training on ankle muscles in adults, may provide an evidence to its use in ankle instability management.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ankle instability, adult volunteers,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 22/03/2015
Actual trial start date 24/03/2015
Anticipated date of last follow up 26/05/2015
Actual Last follow-up date 07/06/2015
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 32
Recruitment status Not yet recruiting
Publication URL Still ongoing
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 randomisation using by using procedures such as coin-tossing Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Wii training 3-4 times per week 6 weeks Performance of 2 selected games from wii menu 16
Control Group No intervention No dose 6 weeks Not performing any traing program 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Normal foot posture index Normal flexibility of ankle muscles Normal full range of motion of ankle joint Manual muscle test of grade 4-5 of Nile muscles No previous history of ankle injury or surgery No participating in any athletic training There isn't any congenital anomalies concerning lower limbs 18 Year(s) 25 Year(s) Male
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 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7Ahmea elzayyat st. Dokki Giza Cairo 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in muscle strength ratio of ankle muscles After 6 weeks
Secondary Outcome Improvement in balance and posture awareness After 1month from the study end date
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Cairo university 7 Ahmed el zayyat st. Dokki ,Giza Cairo 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
There is no funding resources - - -
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy Cairo university 7 Ahmea elzayyat st. Dokki , Giza Cairo 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof.salam mohamed el hafez 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza Cairo 12612 Egypt
Prof.sohair mohamed Abd el Rahman 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza Cairo 12612 Egypt
Dr.ghada Abd elmoneim mohamed 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza Cairo 12612 Egypt
Aya Abd el hamied mohamed 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza Cairo 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aya Abd el hamied Khalil aya.abdelhamid@cu.edu.eg 01281625161 7 Ahmed elzayyat st.
City Postal code Country Position/Affiliation
Dokki,Giza ,Cairo 12612 Egypt Assistant lecturer in biomechanics department faculty of physical therapy Cairo university
Role Name Email Phone Street address
Public Enquiries Ghada Abd elmoneim Mohamed dr_ghaddo@yahoo.com 01006786284 7 ahmed elzayyat st.
City Postal code Country Position/Affiliation
Dokki Giza Cairo 12612 Egypt Lecturer in biomechanics department faculty of physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Salam mohamed Elhafez Egyptsalam@yahoo.co.uk 01094151932 7 ahmed elzayyat st.
City Postal code Country Position/Affiliation
Dokki Giza , Cairo 12612 Egypt Professor and head of biomechanics department faculty of physical therapy Cairo university
REPORTING
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