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.: PACTR202307844195856 Date of Approval: 19/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Different Therapeutic Approaches on Forward Head, Vestibular Function and Balance control in Elderly with Upper Cross syndrome
Official scientific title Effects of Different Therapeutic Approaches on Forward Head, Vestibular Function and Balance control in Elderly with Upper Cross syndrome
Brief summary describing the background and objectives of the trial this proposal is aiming to assess the effect of correction of upper cross syndrome in elderly on static and dynamic balance control, vestibular rehabilitation, chest expansion, forward head and rounded shoulder, and to assess this can lead to improvement of quality of life or not by using different treatment approaches. spinal mobilization, diaphragmatic release in addition to traditional exercise protocol to correct this imbalance in the form of Harman protocol. assessment of forward head by using spinal soft were application, chest expansion by tape measurement, rounded shoulder by supine methods, static balance by modified 4 stage balance test, dynamic balance by biodex stability index, risk of falling by modified fall efficacy scale, quality of life by short form SF12, pain by visual analogue scale, and functional disability by neck disability index.
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 Treatment: Other
Anticipated trial start date 01/03/2022
Actual trial start date 12/03/2022
Anticipated date of last follow up 01/08/2022
Actual Last follow-up date 30/09/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group excersice 3 times per week for 8 weeks 1- Group A Spinal mobilization (upper cervical and upper thoracic mobilization) in addition to exercise intervention 2-group B (diaphragmatic release in addition to postural correction exercise) 3-group C By using foot reflexology 15
Experimental Group excerisce 3 times per week for 8 weeks group B (diaphragmatic release in addition to postural correction exercise) 15
Experimental Group excersice 3 times per week for 8 weeks group C By using foot reflexology 15
Control Group advices 3 trimes per week for 8 weeks advices about how to correct the posture 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria 1- Chronic nonspecific neck patient is defined as neck pain with a duration of more than 3 months (Medina-Mirapeix, et al; 2009) 2-include male and female patients 3-patients age ≥60 up to 75 years (Pociask. et al., 2015) 4- Participants having forward head posture (i.e. CVA ≤ 50 degrees) (Theresa, et al., 2009) 5-Participants had RSP if the distance between "on the table" and the posterior aspect of the acromion process ≥ 2.5 cm (Da-In An et al., 2016). Any patients with any of the following will be excluded from the study 1-Patients with any chest diseases 2-Smoker patients .3-patients with cervical disc prolapse 4-Patients with previous cervical or thoracic surgery 5- Patients that are unable to rate their neck pain on the visual analogue scale (VAS) Aged: 65+ Year(s) 60 Year(s) 75 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 27/02/2022 application for ethical review
Ethics Committee Address
Street address City Postal code Country
ahmed el zayat street cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measurement of the forward head angle- before and after application of excersice
Primary Outcome D-Vestibular system evaluation before and after application of excersice
Primary Outcome assessment of rounded shoulder by supine method before and after application of excersice
Primary Outcome assessment of balance control before and after application of excersice
Secondary Outcome pain intensity before and after application of excersice
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university traffic street cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Reda Gomaa Mohamed Borg Rashid Rashid 22745 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor reda gomaa borg-rashid street el behira 22745 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator reda gomaa redagomaa264@gmail.com 0201145701732 borg rashid street
City Postal code Country Position/Affiliation
rashid 22745 Egypt assisstant lecturer at the faculty of physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries aboelfotouh eid toha37671@gmail.com 0201013472708 el madina el minoura
City Postal code Country Position/Affiliation
naser city 11765 Egypt teacher
Role Name Email Phone Street address
Scientific Enquiries ahmed mahdy ahmed.mahdy@pt.cu.edu.eg 0201007056624 fasial street
City Postal code Country Position/Affiliation
cairo 43518 Egypt assisstant prof at the faculty of physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data obtained through this study may be provided to qualified researchers with academic interest in upper cross syndrome in elderly. data or samples will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are perquisites to the sharing of data with the requesting party Informed Consent Form,Statistical Analysis Plan Data requests can be submitted starting 1 month ago after article publication and the data will be made accessible for up to 36 months, extensions will be considered on a case-by-case basis. controlled type of data Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan (SAP)and execution of a Data Sharing A agreements (DSA)
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