Clinical trial NCT03595826: Co Morbid Attention Deficit and Hyperactivity Disorder(ADHD) and Developmental Co Ordination Disorder (DCD)
Official title: The Effects of Exercise Therapy on the Co-Morbidity of Attention Deficit and Hyperactivity Disorder (ADHD) and Developmental Co-Ordination Disorder. (DCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Developmental Coordination Disorder
Keywords: ADHD/ADD DCD Exercises Neurostimulant Drugs
Lead sponsor: University of KwaZulu
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 151
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 3 phase quasi experimental design. Diagnosis and intervention.
Primary purpose: TREATMENT

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.

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 ADHD/ADD.

Phase 1: Teachers of the children identified with ADHD/ADD, will be asked to complete a modified teacher Conner's rating, to confirm the diagnosis of ADHD/ADD. 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 O.Ts 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 (Conner's, 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.

Eligibility criteria: Inclusion Criteria:

* Age 8 to 9, diagnosed with ADHD, in remedial unit or LSEN class, in mainstream school in Durban Kzn SA.

Exclusion Criteria:

* Any child having an obvious physical disability, neurological condition, musculoskeletal condition, psychiatric disorder or genetic disorder.

Any child below age 8 and above age 9.

Primary outcomes:
measure: Inattention, impulsivity and hyperactivity will be rated, using Conners rating scale.
timeFrame: Aproximately 6 months
Secondary outcomes:
measure: Motor co-ordination will be rated, using DCD questionnaire
timeFrame: Aproximately 6 months.
Other outcomes:
measure: Motor co-ordination will be measured using the Movement Assessment Battery for Children
timeFrame: Aproximately 6 months.
Locations:
city: Durban
country: South Africa
facility: Escombe Primary School
state: Kzn
Study officials:
affiliation: Principal Investigator
name: Pamela M Dawson, M.Physio
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson et al. (2015) DCD. Medscape: Drugs, diseases and Procedures.