Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03595826
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2018-04-22
Brief Title:
Co Morbid Attention Deficit and Hyperactivity DisorderADHD and Developmental Co Ordination Disorder DCD
Sponsor:
University of KwaZulu
Organization:
University of KwaZulu
Study Overview
Official Title:
The Effects of Exercise Therapy on the Co-Morbidity of Attention Deficit and Hyperactivity Disorder ADHD and Developmental Co-Ordination Disorder DCD
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to establish and present the prevalence figures and demographics of the co-morbidity of ADHD and DCD
It further aims to design an exercise intervention to be utilised in the management of the symptoms of both conditions
Furthermore it aims at establishing the efficacy of this exercise intervention when compared with the current and most commonly used intervention that is neurostimulant drugs
It further aims to design an exercise intervention to be utilised in the management of the symptoms of both conditions
Furthermore it aims at establishing the efficacy of this exercise intervention when compared with the current and most commonly used intervention that is neurostimulant drugs
Detailed Description:
This study is an experimental design having three phases The study looks at children aged 8 to 9 in remedial units or LSEN classes in and around Durban Kzn SA who have been diagnosed with ADHDADD
Phase 1 Teachers of the children identified with ADHDADD will be asked to complete a modified teacher Conners rating to confirm the diagnosis of ADHDADD The parent will then be asked to complete a DCD questionnaire DCDQ to give the PI an idea of whether co-ordination difficulties exist The PI will then administer a Motor Assessment Battery for Children MABC to confirm the diagnosis of DCD From the scores derived from the 3 above tests co-morbidity will be diagnosed The prevalence figures of co-morbidity will be calculated and presented Demographics of prevalence figures will be given Gender Population group average age
Phase 2 The exercise intervention will be designed drawing from the literature and similar interventions already used in various publications
This programme will be validated by experts Physiotherapists and OTs from special needs schools and when 70 consensus is reached on all aspects of the programme the final version will be drafted
Phase 3 The children found to have both conditions in co-morbidity will be assigned to one of 4 groups according to parental choice medical advice from paediatricians GPs etc and an intervention a child is already on
The four groups will be medication exercises medication plus exercises and a control group The intervention designed in phase 2 will be administered to the two groups opting for the exercise intervention for a minimum of 8 sessions The 3 pre intervention scores Conners DCDQ and MABC will be derived from phase 1 post intervention scores will be done 6 months after completion of the intervention as it is stipulated by the rules of the MABC that the test may not be repeated sooner The pre and post intervention scores will be compared to calculate improvement and average improvement within each group will be calculated to establish which intervention or combination of interventions is the most effective
Phase 1 Teachers of the children identified with ADHDADD will be asked to complete a modified teacher Conners rating to confirm the diagnosis of ADHDADD The parent will then be asked to complete a DCD questionnaire DCDQ to give the PI an idea of whether co-ordination difficulties exist The PI will then administer a Motor Assessment Battery for Children MABC to confirm the diagnosis of DCD From the scores derived from the 3 above tests co-morbidity will be diagnosed The prevalence figures of co-morbidity will be calculated and presented Demographics of prevalence figures will be given Gender Population group average age
Phase 2 The exercise intervention will be designed drawing from the literature and similar interventions already used in various publications
This programme will be validated by experts Physiotherapists and OTs from special needs schools and when 70 consensus is reached on all aspects of the programme the final version will be drafted
Phase 3 The children found to have both conditions in co-morbidity will be assigned to one of 4 groups according to parental choice medical advice from paediatricians GPs etc and an intervention a child is already on
The four groups will be medication exercises medication plus exercises and a control group The intervention designed in phase 2 will be administered to the two groups opting for the exercise intervention for a minimum of 8 sessions The 3 pre intervention scores Conners DCDQ and MABC will be derived from phase 1 post intervention scores will be done 6 months after completion of the intervention as it is stipulated by the rules of the MABC that the test may not be repeated sooner The pre and post intervention scores will be compared to calculate improvement and average improvement within each group will be calculated to establish which intervention or combination of interventions is the most effective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None