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Clinical Trials/NCT03595826
NCT03595826CompletedNot Applicable

The Effects of Exercise Therapy on the Co-Morbidity of Attention Deficit and Hyperactivity Disorder (ADHD) and Developmental Co-Ordination Disorder. (DCD)

University of KwaZulu1 site in 1 country151 target enrollmentStarted: May 2, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
151
Locations
1
Primary Endpoint
Inattention, impulsivity and hyperactivity will be rated, using Conners rating scale.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Investigator)

Masking Description

The Pi will not be involved in post intervention testing of the children/participants.

Eligibility Criteria

Ages
8 Years to 9 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

1. Neurostimulant pharmaceutical drugs..

Experimental

1.Participants receiving medicinal drugs, such as methylphenidate/Ritalin, administered by a medical practitioner, in dosages prescribed by the practitioner, to suit the child.

Intervention: Neurostimulant pharmaceutical drugs (Drug)

2. Exercise Intervention

Experimental

Participants receiving a minimum of 8 sessions of exercise intervention, for the duration of an hour each session. Exercises will be to build muscle tone, improve core stability, enhance balance, improve fine and gross motor skills and visual motor integration.

Intervention: Neurostimulant pharmaceutical drugs (Drug)

3. Neurostimulants + Exercise intervention

Experimental

See Arms 1 and 2 above. Both interventions administered together: Pharmaceutical drugs plus exercise intervention

Intervention: Neurostimulant pharmaceutical drugs (Drug)

4. Control Group

Experimental

Participants will not receive any intervention during the research process. They will be given an intervention after the research is completed.

Intervention: Neurostimulant pharmaceutical drugs (Drug)

Outcomes

Primary Outcomes

Inattention, impulsivity and hyperactivity will be rated, using Conners rating scale.

Time Frame: Aproximately 6 months

Improvement or regression in symptoms of ADHD will be rated using the modified Conner's teacher rating scale, pre intervention and post intervention: 10 factors on inattention will be rated 0 (Not at all), 1 (Just a little), 2 (Pretty much) and 3 (Very much); 5 factors on impulsivity will be rated using the same scale as above and 5 symptoms of hyperactivity as well. Percentages will be derived from these ratings. A 70% or more indicates a positive diagnosis for inattention/impulsivity/hyperactivity.

Secondary Outcomes

  • Motor co-ordination will be rated, using DCD questionnaire(Aproximately 6 months.)

Investigators

Sponsor
University of KwaZulu
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pam Dawson

Principal Investigator

University of KwaZulu

Study Sites (1)

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