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.: PACTR201206000392602 Date of Approval: 19/06/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Developmental Coordination Disorder Among Primary School Learners in the Cape Town Metro Central Education District
Official scientific title AN ECOLOGICAL APPROACH TO UNDERSTANDING DEVELOPMENTAL COORDINATION DISORDER
Brief summary describing the background and objectives of the trial Developmental coordination disorder(DCD)is a disorder related to the ability to perform motor activities/tasks in a coordinated manner. The global prevalence of DCD is estimated to range between 5-6% among children in the general population. It is unknown whether physiotherapy delivered in the local context can improve performance of children with DCD.The objectives of this trial are to compare the effect of two physiotherapy interventions.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Developmental Coordination Disorder
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 23/07/2012
Actual trial start date 23/07/2012
Anticipated date of last follow up 30/11/2012
Actual Last follow-up date 30/11/2012
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants) 56
Recruitment status Completed
Publication URL http://www.ncbi.nlm.nih.gov/pubmed/23747936
Secondary Ids Issuing authority/Trial register
HREC REF 218/2012 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
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 Masking/blinding used
Parallel: different groups receive different interventions at same time during study Non-randomised Masking/blinding used
Parallel: different groups receive different interventions at same time during study Non-randomised Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neuromotor task training (NTT) 2 hours per week 9 weeks Neuromotor task Training (NTT) is a task orientated intervention approach to treating children with DCD. The tasks used for NTT are designed to engage children in functional exercises as close as possible to the skill required to be learned 37 Active-Treatment of Control Group
Experimental Group Wii Fit 1.5 hours per week 6 weeks The Nintendo Wii Fit is a gaming system designed by Nintendo that incorporates aspects of Biofeedback and Virtual Reality. Motion sensor technology in the form of a hand held control and a force plate, is used to engage the player in video game scenarios 19 Active-Treatment of Control Group
Control Group Standard of care 8 weeks The standard of care consists of giving advice on motor coordination skills to teachers and parents in the form of exercise programmes and running physcal education classes for groups of children. 43 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children between the ages of 7-10 years attending selected schools All participants identified as having DCD whose parents have provided consent and who themselves have provided assent, will proceed on to the intervention phase. DCD is defined as the presence of a functional motor problem detected on screening and a score of >15th percentile on the MABC-2. No specific exclusion criteria will be applied during assessment. For the second phase, participants who are reported to have epilepsy will be excluded from using the Wii Fit game as it has been reported that exposure to video games may trigger seizures. These participants will receive standard care. Participants with an identifiable cause of motor delay (eg. Cerebral palsy), as determined through medical history from parental report and/or clinical examination by the research therapist, will be included in the treatment protocol for ethical reasons. However, their results will be analysed separately. 6 Year(s) 10 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 15/05/2012 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Groote Schuur Hospital, Old Main Buidling, Observatory Cape Town 8000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Scores on the movement assessment battery for children- 2 (MABC-2) baseline week 9
Secondary Outcome 20m shuttle run baseline 9 weeks
Secondary Outcome Functional strength Measure baseline 9 weeks
Secondary Outcome hand held dynamometry baseline 9 weeks
Secondary Outcome muscle power sprint test baseline 9 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Disa Primary School Redberry street, Bonteheuwel Cape Town 8000 South Africa
Bergsig Primary School Dissel Road, Bonteheuwel Cape Town 8000 South Africa
Arcadia Primary School Juniper Street, Bonteheuwel Cape Town 8000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Cape Town Research Committee
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town South Africa University
COLLABORATORS
Name Street address City Postal code Country
Bouwien Smits Engelsman Gebouw De Nayer (GDN) Kamer 02.11, Tervuursevest 101 bus 150, B-3001 Heverlee Leuven Belgium
Dorothee Jelsma de Pol 5A, 9321 VA Peize Groningen Netherlands
Jennifer Jelsma F45 OMB Groote Schuur Hospital Cape Town 7925 South Africa
Niri Naidoo F45 OMB, Groote Schuur Hospital Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gillian Ferguson Gillian.Ferguson@uct.ac.za +27214066045 Department of Health and Rehabilitation Science, F45 Old Main Building, Groote Schuur Hospital, Main Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Gillian Ferguson Gillian.Ferguson@uct.ac.za +27214066045 Department of Health and Rehabilitation Science, F45 Old Main Building, Groote Schuur Hospital, Main Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Bouwien Smits-Engelsman bouwiensmits@hotmail.com + 32 (0)16 32 90 78| Gebouw De Nayer (GDN), Kamer 02.11, Tervuursevest 101 bus 1501,| B-3001 Heverlee
City Postal code Country Position/Affiliation
Leuven Belgium
REPORTING
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