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.: PACTR202006668606204 Date of Approval: 17/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Whole Body Vibration on Craniovertebral Angle and Balance Control in Forward Head Posture
Official scientific title Effect of Whole Body Vibration on Craniovertebral Angle and Balance Control in Forward Head Posture
Brief summary describing the background and objectives of the trial Proper posture is considered to be a state of musculoskeletal balance that involves minimizing stresses and strains acting on the body, deviation from normal alignment can disrupt this balance, leading to abnormal strain on musculoskeletal system and development of a postural problem (Yip et al., 2008).Forward head posture (FHP), one of the most common postural malalignment seen clinically (66%) in which the head is anterior to a line passing through the center of gravity of the body (Mustafa and Diab, 2011). Balance is vital for all the activities of human performance (Ragnarsdottr, 1996), The ability of an individual to maintain balance depends on proprioceptive input from musculotendinous and capsuloligamentous mechanoreceptors in conjunction with visual and vestibular in put to the central nervous system (O'Neill, 2011), Alterations in any of these inputs would likely alter balance and has been shown to be correlated with risk of injury (Kellis et al.,2009).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FHP
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 13/04/2019
Actual trial start date
Anticipated date of last follow up 19/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Completed
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 Whole body vibration device 3times\week 12 session patient stride stand on platform with vibration for ten minute 15
Experimental Group forward head correction exercises 3times\week 12 session stand on vibration device for 10 minute followed by Stretching exercise and strengthening exercises where conducted according to protocol of NDubisson (1999) and principle of kisner and Colby (2007) , finally hot bach and anterior head weighting 15
Control Group anterior head weighting 3times\week 12 session hot back followed by Stretching exercise and strengthening exercises where conducted according to protocol of NDubisson (1999) and principle of kisner and Colby (2007) and frontal head weight for 20 minute during waking 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Both males and females adults will not have any postural deformity by physical examination All follow normal average of weight and height (according to the normal scale for male and female) History of whiplash injury. Current acute pain. Cervical tumor. History of cervical spine surgery. Cervical radiculopathy or myelopathy. Having undergone physical therapy within the past 3 months before the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 25 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 10/04/2018 faculty of physical therapy ethical committe
Ethics Committee Address
Street address City Postal code Country
7th elzayat street giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cranio vertebral angle before and completion of treatment
Secondary Outcome dynamic balance control before and completion of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7th elzayat street giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
asmaa hosam 7th el zayat street giza 11251 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy 7th elzayat street giza 12511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
fatma sedeek 7th elzayat street giza 12511 Egypt
enas aboutaleb 7th elzayat street giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator asmaa hossam husein1986@yahoo.com 01147121294 7th elzayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt assisstant lecturer
Role Name Email Phone Street address
Scientific Enquiries fatma sedek husein1986@yahoo.com 01147121294 7th elzayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt professor
Role Name Email Phone Street address
Public Enquiries enas aboutaleb husein1986@yahoo.com 01147121294 7th elzayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt assiatant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of the trial 1-craniovertebral angle 2- balance Study Protocol one year the criteria will be accessed by the publication of trial in an international journal
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