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.: PACTR201907749053096 Date of Registration: 23/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Core Stability Exercise Combined with Virtual Reality in Collegiate Athletes with Nonspecific Low Back Pain: A Randomized Clinical Trial
Official scientific title Effects of Core Stability Exercise Combined with Virtual Reality in Collegiate Athletes with Nonspecific Low Back Pain: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Background: Nonspecific low back pain (LBP) is a common cause of disability and lost playing time among young athletes. Core stability exercise (CSE) has recently been considered as an integral part of low back rehabilitation programs. Objective: To examine the effect of combined CSE and virtual reality training in improving body balance and dysfunction in collegiate male athletes with nonspecific LBP.
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 12/09/2018
Actual trial start date 12/09/2018
Anticipated date of last follow up 02/01/2019
Actual Last follow-up date 15/01/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group exercise training three Core stability exercise (CSE) 5 days/week over a period of 6 weeks The participants were asked to perform 20 repetitions with 15 seconds, hold for each exercise. The whole exercise set was repeated twice with three minutes rest in between.29 5 days/week over a period of 6 weeks The prone plank; the subjects assumed a front-support position resting on the forearms with shoulders directly over their elbows and legs are straight out behind. Hips were lifted to a degree which makes the whole body from shoulders to ankles is leveled and supported only on forearms and toes. This position could be maintained through coactivation of both lower abdominal and back muscles. The side plank; the subjects lay on each side as they balance on their forearms with the shoulder is directly above the elbow and legs are straight. The pelvis was lifted so that the whole body was balanced on the forearm and feet. The body formed a straight line and the oblique muscles should be felt down the side of the trunk working to maintain the position. Superman plank; subjects laid on their stomach with arms are straight over the head. Both arms and legs were lifted off the ground and kept in this position for the holding period. The experimental group performed the same CSE program of the control group while wearing Oculus rift DK2 as a mean for VR. The Oculus Rift is a lightweight headset, which is developed by Oculus VR (California, USA) to allow its user to feel like they are actually in a game and could look at any direction. The screen displays two images adjacent to each other, one for each eye. The combination of lenses is placed above the screen, enabling the zoom in-out and re-shaping the picture for both eyes, thereby creating stereoscopic 3D images. The image was adjusted according to the wearer’s head motions which were detected by the embedded sensors in the Rift devices.30 Two games were selected, one for each exercise set; No Limits 2 Roller Coaster and Euro Truck 2 simulations. In addition, of being enjoyable for most of the participants, both games require frequent head motions and quick direction changes which facilitate activation of the core muscles. 25
Control Group Exercise Training The control group was instructed to perform three CSE 5 days/week over a period of 6 weeks under the supervision of a certified physical therapist in the Biomechanics laboratory. Barr et al.28 described the selected CSE as being the most commonly used in the previously conducted randomizes control trials. The participants were asked to perform 20 repetitions with 15 seconds, hold for each exercise. The whole exercise set was repeated twice with three minutes rest in between. three CSE 5 days/week over a period of 6 weeks The prone plank; the subjects assumed a front-support position resting on the forearms with shoulders directly over their elbows and legs are straight out behind. Hips were lifted to a degree which makes the whole body from shoulders to ankles is leveled and supported only on forearms and toes. This position could be maintained through coactivation of both lower abdominal and back muscles. The side plank; the subjects lay on each side as they balance on their forearms with the shoulder is directly above the elbow and legs are straight. The pelvis was lifted so that the whole body was balanced on the forearm and feet. The body formed a straight line and the oblique muscles should be felt down the side of the trunk working to maintain the position. Superman plank; subjects laid on their stomach with arms are straight over the head. Both arms and legs were lifted off the ground and kept in this position for the holding period. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) orthopedist confirmed the diagnosis of nonspecific LBP, 2) having 2 or more episodes of LBP during the last year,21 3) positive prone instability test was eligible 4) they were not engaged in any treatment program during the study Patients with nerve root symptoms, underlying systematic or visceral disease, specific conditions such as spondylolysthesis, spondylolysis, ankylosing spondylitis, previous low back surgery vestibular dysfunction, lower extremity injury within the past month or concussion within the past 3 months Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 18 Year(s) 24 Year(s) Male
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 09/09/2018 Faculty of Physical Therapy Research Ethics comittee
Ethics Committee Address
Street address City Postal code Country
Ahmed Elziat Street, Ben Elsaryat, El Dokki, Giza Giza 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Dynamic balance Before intervention and after 6 weeks of intervention
Secondary Outcome Function Before and after 6 weeks of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki, Giza, Egypt Giza 12611 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principle investigator 7 Ahmed Elzayad Street, Dokki, Giza Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki, Giza 12611 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Physical Therapy 7 Ahmed Elzayad, Dokki, Giza Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Osama Ragaa Abdelraouf osamaibrahim2006@yahoo.com +201116471299 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt Assistant professor of biomechanics.
Role Name Email Phone Street address
Scientific Enquiries Amr Almaz Abdel aziem amralmaz@yahoo.com +201006229996 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt professor of Biomechanics
Role Name Email Phone Street address
Public Enquiries Ali Osman Selim pt10.jed@bmc.edu.sa +966547923716 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Olfat Ibrahim Ali Olfat_ib@yahoo.com +201001248426 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Adding VR training to core stability exercise was more effective in improving balance and function in patients with nonspecific LBP compared to core stability exercise alone Statistical Analysis Plan After publication controlled access to the data
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