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.: PACTR201702002011168 Date of Approval: 01/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Motor skills training in adolescents with low motor competence
Official scientific title The efficacy of motor skills training in adolescents with low motor competence in sub-urban areas of Accra.
Brief summary describing the background and objectives of the trial Motor skills deficits are becoming increasingly prevalent in children and adolescents worldwide. Although motor impairments track into adolescence and adulthood, there is insufficient data on adolescents regarding intervention options and potential efficacy of such intervention strategies. Given that motor incoordination is more frequently reported among individuals with lower socioeconomic status, a study that focuses on early identification of Developmental Coordination Disorder (DCD) among the adolescent population is scarce. More importantly, the efficacy of motor training interventions on adolescents with motor coordination deficits has not been well explored. The main aim of this study is to test the efficacy of motor skills training in adolescents with poor motor coordination attending schools in suburban areas of Accra.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ADAMS Trial
Disease(s) or condition(s) being studied Developmental coordination disorder,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 06/02/2017
Actual trial start date 20/02/2017
Anticipated date of last follow up 10/07/2017
Actual Last follow-up date 07/08/2017
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL NA
Secondary Ids Issuing authority/Trial register
NA NA
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 Stratified allocation where factors such as age and gender are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neuromotor task training 2 times per week 60 minutes Task-based skills training involving the use of everyday tasks and games. 30
Control Group Usual care 2 times per week 60 minutes Usual physical education programme 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Boys and girls aged 13-15 years attending junior high schools in selected schools within the Ablekuma South Metropolis. Should have Movement Assessment Battery for Children second edition (MABC-2) score of either at or below the 16th percentile (DCD). Should be willing to participate in the study. Adolescents with documented neurological conditions such as cerebral palsy, epilepsy, and stroke will be excluded. Adolescents with physical impairments like fracture that could hinder participation in testing and intervention will also be excluded. 11 Year(s) 16 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 31/01/2017 The Ethical & Protocol Review Committee, College of Health Sciences, University of Ghana
Ethics Committee Address
Street address City Postal code Country
Korle-BU Accra KB Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome motor coordination pre and post
Secondary Outcome physical activity, fitness outcomes, self-efficacy, enjoyment of physical activity, participation, pre and post
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nanka Bruce school Korle-Gonno Accra 0000 Ghana
MOH school Korle-Bu Accra 0000 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
USHEPiA Rondebosch Cape Town 7700 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Academic Programmes Office University of Cape Town Rondebosch Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Bouwien Smits-Engelsman Observatory Cape Town NA South Africa
Gillian Ferguson Observatory Cape Town NA South Africa
Theresa Burgess Observatory Cape Town NA South Africa
George Awuku Asare Korle-Bu Accra n
George Awuku Asare Korle-Bu Accra NA Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Bonney ebonney10@gmail.com +233 20 440 6549 Korle Bu
City Postal code Country Position/Affiliation
Accra NA South Africa PhD candidate/University of Cape Town
Role Name Email Phone Street address
Public Enquiries Emmanuel Bonney ebonney10@gmail.com +233 20 440 6549 Korle Bu
City Postal code Country Position/Affiliation
Accra NA Ghana PhD candidate/University of Cape Town
Role Name Email Phone Street address
Scientific Enquiries Bouwien Smits-Engelsman bouwiensmits@hotmail.com 0031 681273086 Obervatory
City Postal code Country Position/Affiliation
Cape Town NA South Africa Professor/University of Cape Town
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information