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.: PACTR201602001208365 Date of Approval: 17/07/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of forward head posture correction on central somatosensory conduction time
Official scientific title Impact of forward head posture correction on central somatosensory conduction time
Brief summary describing the background and objectives of the trial Forward head posture, nowadays is very common in any society due to faulty biomechanics of the body and this has bad impact on mechanics and balance of cervical muscle and conduction time of spinal cord and this motivated us to investigate this problem through the following objectives: 1- Identification of the efficacy of forward head posture correction on spinal cord central conduction time 2- Identification of the abnormal pattern of spinal cord central conduction time. 3- Possibility of retaining muscle balance and correct biomechanical abnormalities. 4- Determine the efficacy of Electromyography evoked potentials in measuring the conduction time of spinal cord.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 20/07/2015
Actual trial start date 01/08/2015
Anticipated date of last follow up 31/05/2016
Actual Last follow-up date 30/06/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 30
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group exercise program 3 per week 2 months Experimental group will receive a posture corrective exercise program in the form of two strengthening (deep cervical flexors and shoulder retractors) and two stretching (cervical extensors and pectoral muscles) exercises. The exercise program was done according to Harman et al.¿s protocol and based on Kendall et al.¿s approach. 15
Control Group no treatment 2 months 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- The craniovertebral angle more than 50. then a participant was referred (Selection of 50 as a reference angle was guided by the study of Yib et al. who reported 55:02-2:86 as a normal range and, as it well known, subjects with forward head had a significant smaller craniovertebral angle when compared with normal subjects 1- Spinal canal stenosis, 2- Rheumatoid arthritis and 3- Vestibulobasilar insufficiency. 18 Year(s) 30 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 24/04/2015 ethics comittee in faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
Cairo university Cairo 0020 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome central conduction time after 2 months
Secondary Outcome cranio vertebral angel after 2 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Beni Suef Beni Suef 0020 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Beni Suef University Beni Suef Beni Suef 0020 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni Suef University Salah Salem st. Beni Suef 0020 Egypt University
COLLABORATORS
Name Street address City Postal code Country
faculty of medicin/ Beni suef university Mostafa Kamel st. Beni Suef 0020 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omaima Katabbei omaima_Kattabei@hotmail.com 01222194545 cairo
City Postal code Country Position/Affiliation
Cairo 0020 Egypt Prof. Dr, of physical therapy, faculty of physical therapy , Cairo University
Role Name Email Phone Street address
Principal Investigator Ibrahim Mostafa dr.ibrahim5@gmail.com 01227022334 Cairo
City Postal code Country Position/Affiliation
Cairo 0020 Egypt ass. prof. of physical therapy, cairo University
Role Name Email Phone Street address
Principal Investigator Hanan Hosny hanan_hosny@gmail.com 01001464397 Cairo
City Postal code Country Position/Affiliation
Cairo 0020 Egypt Prof. Dr.of neurophysiology, Faculty of medicin, Cairo University
REPORTING
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Changes to trial information