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.: PACTR202102626129893 Date of Approval: 26/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pilates mat versus cervical stabilization exercises on craniovertebral angle, pain, function of daily life, cervical range of motion, static and dynamic balance young adults with forward head posture: Randomized controlled trial
Official scientific title Pilates mat versus cervical stabilization exercises on static and dynamic balance young adults with forward head posture: Randomized controlled trial
Brief summary describing the background and objectives of the trial In modernized time, extended use of mobile phone and computers has increased anterior weight bearing of cervical spine leading to a variety of musculoskeletal disorders related to the neck by changing the biomechanical stress of cervical spine. Additionally, forward head posture (FHP) alters the COG of the body that lead to mechanical modifications related to postural control in the torso and every joint. The body attempts to adapt to these changes by altering its balance control mechanisms; these adaptations decrease balance ability while performing different activities and increase the risk of falling and musculoskeletal injury.
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 01/08/2021
Actual trial start date 01/08/2021
Anticipated date of last follow up 01/01/2022
Actual Last follow-up date 01/01/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 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 Pilates mat exercises 3 days/ week 12 weeks subjects will be taught 5 key elements of Pilates exercises warm up exercises for 10 minutes main exercise program for 50 min cooling down for 10 min 20
Experimental Group cervical stabilization exercises 3 days/week 12 weeks 20 min/day cervical elongation exercise cranio-cervical flexion with pressure biofeedback unit cranio-cervical extension exercises cervico-scapulothoracic strengthning exercises 20
Control Group conventional physiotherapy 3 days/week 12 weeks hot pack for 10 min ROM EXERCISES isometric neck exercises 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Subjects of both genders aged 18-25 years old with forward head posture will be included in this study. 2- Subjects have FHP if CVA ≤ 50. 3- Subjects complain non- specific neck pain for at least 3 months or at least two episodes of non-specific neck pain during the last three months. 4- Normal body mass index (BMI) (18- 24.9). 1- Subjects with any spinal problems. 2- Temporo-mandibular disease. 3- Subjects with experience in Pilates and who will not sedentary were excluded from the study. 4- Previous surgery in the neck and shoulder regions 5- current participation in a structured exercises program 6- neurological symptoms of the upper extremities during screening tests (e.g., Spurling test and upper limb tension tests) 7- red flags suggesting of cancer, infection, vascular insufficiency. 8- Cervical radiculopathy or mylopathy 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
No 01/07/2021 faculty of physical therapy cairo university ethical commitee
Ethics Committee Address
Street address City Postal code Country
7th el-zayat street Giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Craniovertebral angle will be measured by photogrammetric method. Dynamic balance will be measured by Biodex balance system. Static balance be Romberg test and single limb stance test before and after completion of the study
Secondary Outcome pain by visual analogue scale. Function of daily life by arabic version of neck disability index. cervical range of motion by CROM before and after completion of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy 7th el-zayat street Giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
karima salah 7th el-zayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university 7th el-zayat street Giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
hytham el hafez 7th el-zayat street Giza 12511 Egypt
al shymaa shaaban 7th el-zayat street Giza 12511 Egypt
Ghada Abd el moneam 7th el-zayat street Giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator karima salah karimasalah33@yahoo.com 01027684172 7th el-zayat street
City Postal code Country Position/Affiliation
Giza 12511 Egypt assistant lectrurer faculty of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries hytham el hafez Elhafez@yahoo.com 01001909630 7th el-zayat street
City Postal code Country Position/Affiliation
Giza 12511 Egypt professor of physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries al shymaa shaaban Alshaymaa.shaaban@pt.cu.edu.eg 01033771553 7th el-zayat street
City Postal code Country Position/Affiliation
Giza 12511 Egypt doctor of physical therapy cairo university
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-static and dynamic balance 3-pain level of neck area 4-function of daily life 5-cervical range of motion Study Protocol one year the criteria will be accessed by the publication of trials in 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