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.: PACTR202304813582944 Date of Approval: 04/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of 12-week core stability training on postural balance in Tunisian soccer players with groin pain: A single-blind randomized controlled trial
Official scientific title Effectiveness of 12-week core stability training on postural balance in Tunisian soccer players with groin pain: A single-blind randomized controlled trial
Brief summary describing the background and objectives of the trial Core stability training proved to be effective in improving postural balance in different populations. However, it is still unknown whether core stability training would enhance postural balance in soccer players with groin pain. Thus, this study aimed to investigate the effect of core stability training on postural balance in these players.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 04/01/2022
Actual trial start date 04/01/2022
Anticipated date of last follow up 29/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group core stability training An experienced sports physiotherapist supervised the strict application of the core stability training during 12 weeks. During the first two weeks, participants performed part 1 of the training three times a week (on even or odd days). From the third week, they performed part 2 of the training three times a week (on even or odd days) and performed the exercises of part 1 every other day. A total of 66 sessions was provided 12 weeks The core stability training was adopted from the modified Hölmich protocol, applied in athletes with adductor-related groin pain (Yousefzadeh et al., 2018a). This includes static and dynamic core exercices. 10
Control Group No intervention Nothing 12 weeks This group was not subjected to any additional physical activity program besides the usual training 10 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Players who experienced a unilateral non-time-loss groin pain, for at least 2 months Who did not receive any rehabilitation sessions for groin pain Groin pain classified as a clinical entity according to the Doha agreement Players with pelvic bone fracture sudden onset groin pain inguinal or femoral hernia hip joint disease chronic urinary tract disorders or prostatitis genital-femoral or ilio-inguinal cutaneous nerve entrapments sacroiliac joint pathology back pain prior groin or hip surgery vestibular, visual, musculoskeletal disorders injury history in the past 12 months requiring medical, surgical and/or physical rehabilitation attention Adult: 19 Year-44 Year 19 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 08/02/2020 Comittee of Protection of Persons in South
Ethics Committee Address
Street address City Postal code Country
Road Manzel cheker Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Static and dynamic postural balance Before and immediately after 12 weeks
Secondary Outcome Core endurance, Copenhagen Hip and Groin Outcome Score, functional ability measures Before and after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
a sports medicine center Airport road km 3.5 Sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Chaari Fatma Airport road Km 3.5 Sfax 3000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratory EM2S Airport road Sfax Tunisia Laboratory
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatma CHAARI chaarifatma94@gmail.com +21654341013 Airport road km 3.5
City Postal code Country Position/Affiliation
Sfax Tunisia LR19JS01
Role Name Email Phone Street address
Public Enquiries Fatma CHAARI chaarifatma94@gmail.com +21654341013 Airport road
City Postal code Country Position/Affiliation
Sfax Tunisia LR19JS01
Role Name Email Phone Street address
Scientific Enquiries Fatma CHAARI chaarifatma94@gmail.com +21654341013 Airport road
City Postal code Country Position/Affiliation
Sfax Tunisia LR19JS01
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data from which the results presented in this article are derived, after de-identification (text, tables and figures) Informed Consent Form 12 months following article's publication Researchers who present a methodologically sound proposal
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