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.: PACTR201809729113967 Date of Approval: 26/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF BACKWARD WALKING TRAINING on foot posture, Q angle, pain intensity level, BALANCE AND center of PRESSURE , IN FLAT FOOT
Official scientific title EFFECT OF BACKWARD WALKING TRAINING IN FLAT FOOT SUBJECTS
Brief summary describing the background and objectives of the trial Flat foot represents one of the toughest problems which subjects have nowadays, it is flattening of the medial longitudinal arch, Flat foot cause increase the demand on postural control which influences dynamic balance and disturb normal pressure distribution during walking. Previous studies has been suggested that backward walking allow more efficient recruitment of motor units, it plays a unique role in improving muscle strength of the lower extremities, balance ability, aerobic capacity, and more even distribution of plantar pressure
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BW
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Exercise
Anticipated trial start date 15/09/2018
Actual trial start date
Anticipated date of last follow up 01/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group backward walking plus physical therapy exercise programe 3 times/week 36 session per 3 months backward walking on treadmill 30 min, 3 times/week, for 12 week plus a traditional physical therapy exercise program for flat foot (Short foot exercise for flat foot, Towel toe curl exercise (TCE), Heel Raise exercise, Calf Stretch) 30
Control Group traditional treatment 3 times/week for 3 month 36 session per 3 month traditional physical therapy exercise program for flat foot (Short foot exercise for flat foot, Towel toe curl exercise (TCE), Heel Raise exercise, Calf Stretch 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Sixty Subjects will be selected from both gender, their age will ranged from 19-35 years (Tsai et al., 2006), from Faculty of Physical therapy. 2. Subjects with bilateral mobile flat foot that will be indicated by foot posture index ranging from +6 to +9 (Redmond et al.,2008). 3. Body Mass Index (BMI) from 18 to 25 kg/m² 1. History of surgery to the lower extremity. 2. History of cerebral concussions, visual or vestibular disorders. 3. Any neurological deficit affecting balance (dizziness). 4. A history of any conditions affects muscle strength: diabetes mellitus, rheumatoid arthritis. 5. History of radiculopathy, previous back surgery or vertebral compression fracture. 6. Lower extremities problems (e.g. Atrophy, extremity shortness as leg length discrepancy more than 2 cm. Adult: 19 Year-44 Year 19 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
Yes 01/10/2017 physical therapy of ethical committee
Ethics Committee Address
Street address City Postal code Country
7th streat of ahmed el zyat giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome blance, center of pressure before and after completion of treatment
Secondary Outcome Q angle , Pain intensity level and foot posture before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university 7th st of ahmed elzyat giza 12613 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 cairo university bin elsaryat ciza 12613 Egypt University
Secondary Sponsor faculty of physical therapy 7th streat of ahmed el zyat giza 12613 Egypt educatioal
COLLABORATORS
Name Street address City Postal code Country
Amal Hassan Mohammed Ibrahim 7th streat of ahmed elzyat giza 12613 Egypt
Ashraf Nehad Moharam 7th streat of ahmed elzyat giza 12613 Egypt
Marwa Shafiek Mustafa 7th steat of ahmed elzyat giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amal Ibrahim aebrahim123@hotmail.com 01200861702 7th streat of ahmed el zyat
City Postal code Country Position/Affiliation
giza 12613 Egypt Professor of physical therapy
Role Name Email Phone Street address
Public Enquiries Marwa Mustafa Marwa_shafiek2000@yahoo.com 00201008342466 7th streat of ahmed el zyat
City Postal code Country Position/Affiliation
giza 12613 Egypt Lecturer of physical tharapy
Role Name Email Phone Street address
Scientific Enquiries Ashraf Moharam Dr.amoharram@gmail.com 00201001420049 7th streat of ahmed el zyat
City Postal code Country Position/Affiliation
giza 12613 Egypt Professor of Orthopedic Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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