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.: PACTR202311749369035 Date of Approval: 28/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Motor skills, physical condition and cognitive function in schooled and trained children
Official scientific title The effects of task-oriented basketball training on motor skill-related fitness and dart throwing in children with developmental coordination disorder
Brief summary describing the background and objectives of the trial developmental coordination disorder (DCD) is classified as a motor learning deficit because it interferes with the ability to learn and automate movement abilities. There is still a lack of information on how these children acquire complex motor skills relevant to their daily life like in a game-like situation. However, there is no evidence to guide physical trainers, educators and health professionals to select the efficacy type of exercise for the therapy of decreased physical fitness in DCD children. The purpose of this study was to examine the effect of an 8-week task-oriented basketball training program on motor coordination, motor skill-related fitness and dart throwing in children with DCD.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/04/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 58
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 Non-randomised Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group DCD training group 8 weeks A motor skill training program focused on basketball skills was administered for eight weeks, three times a week in 60-minute sessions for the DCD training-group. Two coaches trained all 18 children as they exercised in one group at the same time. The program includes a 10-minute warm-up, 30-35-minute fitness and agility training using basketball drills, 10 minutes shooting basketballs from various distances, a 15-minute reduced basketball game 3 versus 3, and a 5-minute rest time. Two coaches in charge of the DCD training group (Physical and special education teachers) introduced and explained the basketball game rules. 18
Control Group DCD non training group 8 weeks Usual care group: The DCD non-training group continued with their regular classroom activities and received no additional training throughout the trial. 20 Active-Treatment of Control Group
Control Group TD non training group 8 weeks Usual care group: the TD group continued with their regular classroom activities and received no additional training throughout the trial. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
who were identified by a parent or teacher as having a motor coordination impairment, whose parents noted difficulty throughout the early developmental period, where no medical condition or comorbidity known to interfere with motor abilities was noted, whose teacher validated the absence of intellectual or cognitive disability There is no sign of functional motor difficulties as noted by their teacher or parent, an MABC-2 score above the 16th percentile, no severe medical condition as noted by a parent, as certified by their teacher, they have no intellectual or cognitive impairment. Child: 6 Year-12 Year 6 Year(s) 12 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 17/01/2021 SOUTH PERSONAL PROTECTION COMMITTEE C.P.P.SUD
Ethics Committee Address
Street address City Postal code Country
Route EL EIN km 0.5 Sfax, Tunisia Sfax 3000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome MABC-2 score, PERF-FIT test 8 weeks pres and post test
Secondary Outcome Dart throw 8 weeks pres and post tests
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medecine sfax tunisia Route El INE Km 0.5 Sfax, Tunisia Sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
High Institute of Sport and Physical Education of Sfax Tunisia airport road km 6 Sfax, Tunisia Sfax 3000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ministry of Higher Education and Scientific Research Tunisia Kairouan Avenue, Tunis 1006, Tunisia Tunis 1006 Tunisia University
Secondary Sponsor Ministry of Education rue De La Chevrotiere, Tunis, Tunisia Tunis 1035 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faical Farhat faicalfarhat@gmail.com +21624374148 Route de Mahdia, Sfax, Tunisia
City Postal code Country Position/Affiliation
Sfax 3002 Tunisia High Institute of Sport and Physical Education of Sfax University of Sfax Tunisia.
Role Name Email Phone Street address
Public Enquiries Adnene Gharbi adnenegharbi@yahoo.fr +21621248135 Route Saltnia km 7 Sfax, Tunisia
City Postal code Country Position/Affiliation
Sfax 3002 Tunisia High Institute of Sport and Physical Education of Sfax University of Sfax Tunisia
Role Name Email Phone Street address
Scientific Enquiries Mohame Moncef Kammoun moncefkammoun@yahoo.fr +21624243231 Route Saltnia Sfax Tunisia
City Postal code Country Position/Affiliation
Safx 3000 Tunisia High Institute of Sport and Physical Education of Sfax University of Sfax Tunisia.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes - What data in particular will be shared: All of the individual participant data collected during the trial, after deidentification. - What other documents will be available: Study Protocol - When will data be available : Immediately following publication. 2 years end date - With whom: Investigators whose proposed use of the data has been approved by an independent review committee - For what types of analyses: For individual participant data meta-analysis - By what mechanism will data be made available: Proposals should be directed to principal author: email; faicalfarhat@gmail.com Study Protocol 2 years Access criteria controlled Data analysis criteria permitted by principal author Reviewing qualification
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