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.: PACTR202108675488120 Date of Approval: 06/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of the proprioceptive neuromuscular facilitation exercise programs on idiopathic scoliosis patients in the school age in terms of pain, functional performance and pulmonary function: randomized clinical study
Official scientific title Effects of the proprioceptive neuromuscular facilitation exercise programs on idiopathic scoliosis patients in the school age in terms of pain, functional performance and pulmonary function.
Brief summary describing the background and objectives of the trial Scoliosis is the most common 3-dimensional deformation abnormality of the spine with direct effects on the thoracic cage, with a reported prevalence in the general population varying significantly from 0.3% to 15.3% [Trobisch et al., 2010]. It is the result of a pathologic process which leads to lateral curvature of the spine. It can be congenital, due to vertebral or rib malformation, secondary to a variety of systemic or neuromuscular disorders, or idiopathic. Idiopathic scoliosis accounts for approximately 85% of cases and it is defined as a structural scoliosis for which no specific cause can be established [Praud and canet 2002]. The effects of scoliosis in the anatomy of the chest are quite complex. It was reported that the plot of segmental thoracic ratios by age groups, a method of assessment of the morphology of rib cage in anteroposterior radiographs, is one way of expressing the proportional changes of thoracic viscera, mainly the heart and lungs and principally the lungs during growth [Grivas et al.,1992].
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 01/06/2021
Actual trial start date 01/06/2021
Anticipated date of last follow up 10/08/2021
Actual Last follow-up date 30/09/2021
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PROPRIOCEPTION NEUROMUSCLAR TRAINING PNF THREE VISITS/WEEK 30 MINUTES EACH SESSION. 6 WEEKS the PNF patterns and techniques were appropriately used. The PNF techniques that were used in the programs in this study also included the principle of combination of isotonics applied to the treatment of the patient. The PNF exercise programs, which were executed for a total of six weeks, consisted of three sessions a week, with each session lasting 30 min. It combined two to three exercise programs in accordance with the level of adaptation of the patient to the exercises. Before beginning the exercise in earnest, the overall progress of the exercise and how to breathe deeply were explained to the subject 30
Control Group TRADTIONAL TREATMENT THREE VISITS/WEEK 30 MINUTES EACH 6 WEEKS Moist hot pack TENS US 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) 60 patients with scitica. 2) The age of patients will range from 14-17 years old. 1) Had acute episode of low back pain. 2) Patients recived physical therapy for acute condition in last three months. 3) spinal surgery. 4) complained of any neurological signs. Adolescent: 13 Year-18 Year 13 Year(s) 17 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 30/05/2021 faculty of physical therapy Cairo University.
Ethics Committee Address
Street address City Postal code Country
7 elzayyat street Giza 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome FVC, FEV1, and FEV1/FVC ratio pre and post treatment
Secondary Outcome The TUG test pre and post treatment
Secondary Outcome Pain pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alagouza language secondary school 25 mohamed aouf stret Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
MAHMOUD DIAB 7 AHMED ELZAYYAT DOKKI 11311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Eman Mohamed Fahmy 7 ahmed elzayyat St Dokki Giza Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud mohamed dr.mahmouddiab11@gmail.com 01117750496 7 ahmed elzayyat dokki
City Postal code Country Position/Affiliation
Giza Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Ehab Ali eabdallah@horus.edu.eg 01223674916 7 ahmed elzayyat Dokki
City Postal code Country Position/Affiliation
Giza Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries taher taha ttaha@horus.edu.eg 01017721814 7 ahmed elzayyat
City Postal code Country Position/Affiliation
Giza Egypt LECTURER
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will perform the pain, functional performance and pulmonary function. pre treatment and after the rehabilitation which will last for 6 weeks Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IMMEDIATLY FOLLOWING PUBLICATION, NO END DATA DATA ARE AVAIALBLE INDEFINITELY
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