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.: PACTR201801002937158 Date of Approval: 02/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Correlation of Head Malalignment of Head Posture and Proprioception Function in Patients with Cervical Spondylosis
Official scientific title Correlation of Head Malalignment of Head Posture and Proprioception Function in Patients with Cervical Spondylosis
Brief summary describing the background and objectives of the trial Determine the correlation between malalignment of head posture and proprioception function in patients with cervical spondylosis. Also, to compare proprioception errors in forward head posture with different severities of cervical spondylosis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cervical spondylosis,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/04/2017
Actual trial start date 01/04/2017
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date 01/12/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC/012/001552 cairo university faculty of physical therapy research ethical comittee
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 Simple randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used) Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group proprioception and FHP evaluatuin 1 session 1 hour measure proprioception function and detect head malalignment 20 Dose Comparison
Control Group proprioception assessment 1 hour 1session prorioception assessment using kinethetic sensiblity tests 20 Dose Comparison
Control Group proprioception assessment with severe spondylosis 1 hour 1 session prorioception assessment using kinethetic sensiblity test 20 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Sixty Cervical spondylosis patients from both sexes were participated in this study. ¿ Cervical spondylosis confirmed radiological and determined the degree of severity according to The Cervical Degenerative Index (Cote et al., 1997) (Appendix III). ¿ The patients¿ ages ranged from 30-50 years. ¿ Patients with onset of presenting neck pain episode after trauma (eg, whiplash). ¿ Patients with history of cervical injury of trauma since the onset of presenting neck episode. ¿ Patients with history of cervical injury or trauma. ¿ Patients with cervical myelopathy. ¿ Patients with inflammatory arthritis involving cervical spine. ¿ Patients with Tumor or infection involving C-spine. ¿ Patients with vertebrobasilar artery insufficiency. ¿ Patients with neurologic disease (eg multiple sclerosis, Parkinson's disease, syringomyelia. ¿ Patients with Congenital anomalies involving C-spine. ¿ Patients with Diabetes mellitus. ¿ Patients with vestibular system impairements. 30 Year(s) 50 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 12/02/2017 Research ethical committee of faculty of physical therapy, cairo university
Ethics Committee Address
Street address City Postal code Country
el-tahrir st.- in front of ben el-sarayat, traffic dokki. cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome forward head posture single time outcome
Secondary Outcome proprioception assessment single time outcome
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university faculty of physical therapy, physical therapy clinic el-tahrir st.- in front of ben el-sarayat, traffic dokki. cairo 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of physical therapy, cairo university el-tahrir st.- in front of ben el-sarayat, traffic dokki. cairo 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university el-tahrir st.- in front of ben el-sarayat, traffic dokki. cairo 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Moshera H. Darwish, Amr Hassan, , Heba A. Khalifa, Ibrahim A. Abu-Ellaa el-tahrir st.- in front of ben el-sarayat, traffic dokki. cairo 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ibrahim abu ella ibrahimneuron@gmail.com +201008442281 el-tahrir st.- in front of ben el-sarayat, traffic dokki
City Postal code Country Position/Affiliation
cairo 11432 Egypt professor of neurology
Role Name Email Phone Street address
Public Enquiries moshira darwish Dr.moshera11@yahoo.com +201015163617 el-tahrir st.- in front of ben el-sarayat, traffic dokki
City Postal code Country Position/Affiliation
cairo 11432 Egypt professor of neurology
Role Name Email Phone Street address
Scientific Enquiries heba khalifa dr_hobi@yahoo.com +201289213128 el-tahrir st.- in front of ben el-sarayat, traffic dokki
City Postal code Country Position/Affiliation
cairo 11432 Egypt lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information