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.: PACTR202010531232430 Date of Approval: 29/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implementation of Head Postural Correction Program "postural correction exercises, kinesiotaping and scapular stabilization exercises" in Forward Head Posture
Official scientific title Implementation of Head Postural Correction Program "postural correction exercises, kinesiotaping and scapular stabilization exercises" in Forward Head Posture
Brief summary describing the background and objectives of the trial PURPOSE: The aim of this study is to determine the following: 1. The efficacy of postural correction exercises on position of scapula, craniovertebral angle (CVA) and dominant hand grip strength. 2. The efficacy of adding scapular stabilization exercises to postural correction exercises on position of scapula, craniovertebral angle (CVA) and dominant hand grip strength. 3. The efficacy of adding kinesiotaping to postural correction exercises on position of scapula, craniovertebral angle (CVA) and dominant hand grip strength. 4. The efficacy of adding both scapular stabilization exercises and kinesiotaping to postural correction exercises on position of scapula, craniovertebral angle (CVA) and dominant hand grip strength. BACKGROUND: Every activity of daily living needs a certain pattern of posture to be maintained. Any deviations from the normal postural pattern caused by imbalance in the muscles, adversely affects the adjacent joint & muscles leading to pathological conditions, greater incidence of pain in the upper quadrant reduced quality of life (Blyth et al., 2019). Persons who work for long hours used to adapt poor work posture e.g. forward head position FHP, protracted shoulder and Abnormal or altered scapular position (Depreli et al., 2016). Research has shown several ways to correct FHP and FSP, including manual therapy, postural re-education, using taping, orthoses, and exercise therapy (Andersen et al., 2011).The goals of implementing all these methods, especially exercise therapy (corrective movements) for correcting these deformities is to improve the range of motion, increase the flexibility, increase the strength of the weakened muscles, and in general, eliminate muscle imbalance (establishing a balance between muscles involved in deformity) (Fathollahnejad et al 2019).
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 01/11/2020
Actual trial start date 01/11/2020
Anticipated date of last follow up 01/11/2021
Actual Last follow-up date 01/11/2021
Anticipated target sample size (number of participants) 120
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
Parallel: different groups receive different interventions at same time during study 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
Control Group postural correction exercise 4 sessions per week 4 weeks Postural correction exercises involving repeated cervical and scapular retractions are commonly used for managing neck disorders in order to rectify underlying pathomechanics problems as well as reduce upper trapezius muscle spasms (Mclean 2005) and allow the potential for a change in postural habits to develop (Morningstar 2002). 30 Active-Treatment of Control Group
Experimental Group scapular stabilization exercises 4 sessions per week 4 weeks Scapular stabilization exercises included specific exercises on the basis of muscles affecting the scapula orientation related to neck pain. The exercise program aimed to create a neutral spine and activate the neuromuscular pattern in the serratus anterior, trapezius, and rhomboids (Celenay 2016). 30
Experimental Group kinesiotaping the tape will be replaced each 3 days 4 weeks KT was introduced by Kenzo Kase in 1996, which normally involves a combination of applying appropriate tension along the elastic therapeutic tape and placing the target muscle in a stretched position and is widely used as an interesting and relatively novel method for various clinical treatments. By supporting weak muscle, relaxing the overstretched muscle, and reducing pain (Hu et al., 2019). 30
Experimental Group combination of the following interventions posturalcorrection scapular stabilization kinesiotaping 4 sessions per week for postural correction and scapular stabilization the tape will be added every 3 days as for kinesiotaping 4 weeks Postural Correction Exercises: Postural correction exercises involving repeated cervical and scapular retractions are commonly used for managing neck disorders in order to rectify underlying pathomechanics problems as well as reduce 12 upper trapezius muscle spasms (Mclean 2005) and allow the potential for a change in postural habits to develop (Morningstar 2002). Scapular stabilization exercises: Scapular stabilization exercises included specific exercises on the basis of muscles affecting the scapula orientation related to neck pain. The exercise program aimed to create a neutral spine and activate the neuromuscular pattern in the serratus anterior, trapezius and rhomboids (Celenay 2016). Kinesiotaping: KT was introduced by Kenzo Kase in 1996, which normally involves a combination of applying appropriate tension along the elastic therapeutic tape and placing the target muscle in a stretched position and is widely used as an interesting and relatively novel method for various clinical treatments. By supporting weak muscle, relaxing the overstretched muscle, and reducing pain (Hu et al., 2019). 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants will be chosen under the following criteria: 1) Subjects with asymptomatic forward head posture with CVA less than 50 degrees (Yip 2008). 2) Both genders will be included. 3) The age of the participants will be ranged from 18: 60 years old (Gurudut and Gauns 2016). 4) Subjects will be recruited from Cairo and Damietta metropolitan areas. The potential participation will be excluded when they had one of the following criteria: 1) Fixed or mobile spinal deformity. 27 2) Surgery and post-operative pain. 3) Congenital deformities of neck and shoulders. 4) Visual disorders. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 09/09/2020 Research Ethics Team Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 ahmed el zayat st Giza Dokki Cairo 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome craniovertebral angle (CVA) as the primary outcome pre and post measurements only
Secondary Outcome position of scapula pre and post measurement
Secondary Outcome dominant hand grip strength pre and post measurement
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Outpatient clinic 7 Ahmed Elzayat st,Giza,Dokki Cairo Egypt
The Specialized Damietta Hospital Al Aasar,Kornish El Nil, Qism Damietta,Damietta Damietta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Marwa Adel Abd Elghaffar cairo and damietta cairo and damietta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University 7 Ahmed Elzayat st Giza dokki Cairo 12622 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elgendy Prof.mgendy@hotmail.com +201100124441 7 Ahmed Elzayat st, Giza Dokki
City Postal code Country Position/Affiliation
Cairo 12622 Egypt Chairman of Basic Sciences department
Role Name Email Phone Street address
Public Enquiries Samir ElSabbahi ssabbahi@hotmail.com +201128377738 7 Ahmed Elzayat st, Giza Dokki
City Postal code Country Position/Affiliation
Cairo 12622 Egypt Professor of Basic Sciences
Role Name Email Phone Street address
Scientific Enquiries Enas Abutaleb enas_abutaleb@yahoo.com +201001468054 7 Ahmed Elzayat st, Giza Dokki
City Postal code Country Position/Affiliation
Cairo 12622 Egypt Associate Professor of Basic Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol Beginning 3 months and ending 5 years following article publication Proposal may be submitted up to 36 months following article publication. After 36 months the dta will be available in out University’s data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing date may be found at ( info@pt.cu.edu.eg )
URL Results Available Results Summary Result Posting Date First Journal Publication Date
info@pt.cu.edu.eg 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