Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008472102482 Date of Approval: 12/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Efficacy of Theraband versus General Active Exercise in Improving Postural Kyphosis
Official scientific title The Efficacy of Theraband versus General Active Exercise in Improving Postural Kyphosis
Brief summary describing the background and objectives of the trial Thoracic kyphotic posture is accompanying increased biomechanical load of the backbone which is possibly problematic. The current study aimed to examine the effects of general active exercise versus Theraband exercise on female kyphotic posture.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/01/2020
Actual trial start date
Anticipated date of last follow up 15/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 14
Actual target sample size (number of participants) 14
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Theraband exercise 60 minutes in 3 sessions per week The intervention was conducted properly for 60 minutes in 3 sessions per week for 4 weeks (total of 12 sessions per week) Theraband active exercises (neck retraction exercise, scapular retraction exercise, and resistive shoulder blade squeeze) from standing position were conducted; the 1st exercise: neck active retraction exercise was performed by placing the midline of the band around the most prominent area of the posterior aspect of the back of the head and grasping both ends of the band in front of the head, the subject maintains the neutral position of the neck with the movement of the chain slightly backward, stretching the band forward as much as possible with keeping the neck in a neutral position. The 2nd exercise: scapular active retraction exercise was performed by fixing the band on a solid object at the waist level, each subject holding one end of the band in each hand, with elbows bent 90 degrees at the side of the body, the band pulled backward to move shoulder blades toward each other. The 3rd exercise: resistive shoulder blade squeeze was performed through the holding of both ends of the band with the hands in front of the body and keeping the elbow 90 degrees flexed, the hand palms face up and the subject squeezes shoulder blades together, and move arms to the outside to stretch the band, each subject should keep her elbows at the body sides while she was doing this exercise. 7
Control Group general active exercises 60 minutes in 3 sessions per week the exercise was conducted properly for 60 minutes in 3 sessions per week for 4 weeks (total of 12 sessions per week) general active exercises (Thoracic stretching exercise, thoracic extension exercises, and extension in lying with cervical retraction exercises) were conducted; the 1st exercise: thoracic stretching exercise was conducted through using a roller to hinge the upper back backward over the roller in the supine position. The 2nd exercise: thoracic extension exercise was conducted through clasping both arms behind the head and gently arching towards the back and looking up. The 3rd exercise: extension in lying with cervical retraction exercises was conducted by extending the upper cervical and thoracic spine from the prone position. 7 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria included: i) the age of the subject ranged from 18-30 years old. ii) all subjects are female university students who are diagnosed as kyphosis. iii) they didn't engage in any physical activities. iv) all of them have pain level >6. The participants with any musculoskeletal abnormalities, pregnancy, neurological abnormalities, and surgical operation of the last 4 months were excluded from the study. Any analgesic or anti-inflammatory drug or any other physical therapy treatment has not been given through the treatment. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 30 Year(s) Female
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 05/01/2020 Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elziat Street, Ben Elsarayat, El Dokki, Faculty of Physical Therapy, Cairo University, Biomechanics Department, Giza, Egypt. Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The improve of the thoracic kyphotic posture Thoracic kyphotic index
Secondary Outcome the pain and the back disability. Visual analogue scale and back disability index questionnaire
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University 7 Ahmed Elziat Street, Ben Elsarayat, El Dokki, Faculty of Physical Therapy, Cairo University, Biomechanics Department, Giza, Egypt. Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
primary invigilator Amany E Abd Eltawab Biomechanics department Physical Theraspy College Cairo University 7 Ahmed Elziat Street, Ben Elsarayat, El Dokki, Faculty of Physical Therapy, Cairo University, Biomechanics Department, Giza, Egypt Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Physical Therapy College Cairo University 7 Ahmed Elziat Street, Ben Elsarayat, El Dokki, Faculty of Physical Therapy, Cairo University, Biomechanics Department, Giza, Egypt. Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mariam A. Ameer 3 Algomhoria st., Naser City, Cairo, Egypt Cairo 11713 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany AbdEltawab dramanysleem@yahoo.com 00966541806736 Fayom, Cairo, Egypt
City Postal code Country Position/Affiliation
Fayom Egypt Biomechanics Department Physcial Therapy College Cairo University
Role Name Email Phone Street address
Public Enquiries Mariam Ameer mariam.abdelmonim@cu.edu.eg 00201094169696 3 Algomhoria st., Naser city, Cairo
City Postal code Country Position/Affiliation
Cairo 11713 Egypt Biomechanics Department Physical Therapy College Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mariam Ameer mariam.abdelmonim@cu.edu.eg 00201094169696 3 Algomhoria st., Nacer city, Cairo
City Postal code Country Position/Affiliation
Cairo 11713 Egypt Biomechanics Department Physical Therapy College Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Fourteen female university students (age= 22.14 ± 1.9yr, Mass= 66.14± 19.22 Kg, Height=157±7.6 cm, BMI= 26.5±5.5Kg/m2) were diagnosed by a physician (x-ray examination) as kyphotic posture ( the kyphotic angle was 50 degree or greater that detected by x-ray) with a pain level of more than 6 out of 10 on the visual analogue scale (VAS). Informed Consent Form,Statistical Analysis Plan,Study Protocol it had already shared in the statement above it will be controlled, and data are quantitative. Data will be analyzed using SPSS program version 20 to determine the effect of general active exercises and Theraband on kyphotic female posture. Data were represented as mean and standard deviation. Homogeneity of data was verified by a Shapiro-Wilk test, ensuring equality of variance and normality of data. A Paired sample test was used to evaluate the effect of treatment within each group (pre and post-treatment) according to the mean values of IK (primary outcome), percentage score of BDI, and Pain score (secondary outcomes) at a level of p<0.05. Moreover, Independent T-test was used to analyze the difference in BDI, pain score, and IK pre and post-treatment intervention between first and second groups.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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