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.: PACTR201703002094205 Date of Approval: 12/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of scapular stabilization exercises on asymptomatic forward head posture; a randomized controlled trial
Official scientific title Influence of scapular stabilization exercises on craniovertebral angle ,muscle amplitude,range of motion , neck flexion endurance and neck extension endurance on asymptomatic subjects with forward head posture
Brief summary describing the background and objectives of the trial Forward head posture (FHP) is the most common deviation from ideal head posture and is characterized by the head projecting forward into the sagittal plane such that it is anterior to the trunk. The scapulothoracic kinematics are also affected by abnormal posture of thoracic and cervical spine. Serratus anterior and trapezius muscles play a major role in creating and controlling the movements of scapula and leads to upward rotation, external rotation and posterior tilt of scapula as a paired force.Power analysis will be done to detect sample size. Fourty asymptomatic subjects from both genders with carnio-vertebral angle (CVA) less than 50 or equal. They will be assigned randomly in two groups A & B. Forward head posture will be measured by cranio-vertebral angle (CVA). (Measuring less than or equal 50). Muscle activity will be measured by electromyography. Endurance of deep cervical muscles will be measured by neck flexors endurance test (NFET) and extensors endurance test (NEET).Cervical ROM will be measured by cervical range of motion. Expremintal group (A) will receive scapular stabilization exercises and postural correctional exercises 3 times/ week for 10 weeks. Control group (B) will receive postural correctional exercises only 3 times /week for 10 weeks.in form of : Stretching of ( sub-occipital muscles ¿pectoralis major) Strengthening (deep cervical flexors- scapular retractors)
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FHP CVA NFET NEET
Disease(s) or condition(s) being studied Forward head poature
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2017
Actual trial start date
Anticipated date of last follow up 01/06/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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 by permuted block randomization by third person Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised by permuted block randomization by third person Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group scapular stabilization exercises and postural correctional exercises 3 times per week 10 weeks scapular stabilization exercises composed of five stages(supine,crook lying ,quadriped ,sitting then sitting in front of mirror) and postural correctional exercises composed of stretching (sub-occipital muscles-pectoralis major) and strengthening (scapular retractors -deep cervical flexors) 20
Control Group postural correctional exercises 3 times per week 10 weeks Stretching of ( sub-occipital muscles ¿pectoralis major) and strengthening of (scapular retractors-deep cervical flexors) 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Asymptomatic participants. 2.Age ranging from 20: 30 (Harman et al.2005). 2.CVA equal or less than 50 ( Yib et al .,2008). 4.shoulder flexion at least 130 degrees or more. 1. Headache, miagraine or vertebra-basilar insufficiency (VBI). 2. Cervical spondylosis . 1.Cervical or shoulder neurological movement disorder. 2.Temporomandibular surgery. 3.Pathologic trauma. 4.cervical spine fracture. 5.History surgery of the upper quadrant of the body 20 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
No 12/04/2017 faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 elzayat street cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cranio -vertebral angle will be measured pre- treatment and pos-treatment
Primary Outcome neck flexion and extension endurance test will be measured before treatment and after treatment
Secondary Outcome muscle amplitude will be measured before and after treatment
Secondary Outcome range of motion will be measured before and after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
elshiekh zayed al nahyan autostrad street beside monshaat naser cairo Egypt
elkasr eleiny elkasr eleiny street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal madint nasr 44 emam abo hanifa street cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university giza Egypt University
Secondary Sponsor faculty of physical tjerapy 7th zayaat street giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
prof/dr.ragia mohammed kamel 7th elzayaat street giza Egypt
yasser ramzy lasheen 7th zayaat street giza Egypt
amir nazih 7th zayaat street giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ragia mohammed kamel anazih@hotmail.com 01220773033 7th zayaat street
City Postal code Country Position/Affiliation
giza Egypt proffessor
Role Name Email Phone Street address
Public Enquiries yasser ramzy lasheen dr_yasser_1977@yahoo.com 01005251562 7th zayaat street
City Postal code Country Position/Affiliation
giza Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries amir nazih anazih@hotmail.com 01222367919 7th zayaat street
City Postal code Country Position/Affiliation
giza Egypt lecturer
REPORTING
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