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Co Morbid Attention Deficit and Hyperactivity Disorder(ADHD) and Developmental Co Ordination Disorder (DCD)

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Developmental Coordination Disorder

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Neurostimulant pharmaceutical drugs
Sponsored by
University of KwaZulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD/ADD DCD Exercises Neurostimulant Drugs

Eligibility Criteria

8 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Escombe Primary School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1. Neurostimulant pharmaceutical drugs..

2. Exercise Intervention

3. Neurostimulants + Exercise intervention

4. Control Group

Arm Description

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

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.

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

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

Outcomes

Primary Outcome Measures

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

Motor co-ordination will be rated, using DCD questionnaire
Improvement or regression in symptoms of co ordination, will be rated by the parent, using the Developmental Co-ordination Disorder Questionnaire, pre and post intervention: 15 statements related to co-ordination will be rated on the following scale: 1 (Not at all like child), 2 (A bit like child), 3 (Moderately like child), 4 (Quite a bit like child) and 5 (Extremely like child). The score will be totalled and scores of 55 and above mean that the child does NOT have co-ordination issues, scores below 55 indicate that the child has co-ordination issues.

Full Information

First Posted
April 22, 2018
Last Updated
November 25, 2020
Sponsor
University of KwaZulu
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1. Study Identification

Unique Protocol Identification Number
NCT03595826
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of KwaZulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Developmental Coordination Disorder
Keywords
ADHD/ADD DCD Exercises Neurostimulant Drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
3 phase quasi experimental design. Diagnosis and intervention.
Masking
Investigator
Masking Description
The Pi will not be involved in post intervention testing of the children/participants.
Allocation
Non-Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Neurostimulant pharmaceutical drugs..
Arm Type
Experimental
Arm Description
1.Participants receiving medicinal drugs, such as methylphenidate/Ritalin, administered by a medical practitioner, in dosages prescribed by the practitioner, to suit the child.
Arm Title
2. Exercise Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
3. Neurostimulants + Exercise intervention
Arm Type
Experimental
Arm Description
See Arms 1 and 2 above. Both interventions administered together: Pharmaceutical drugs plus exercise intervention
Arm Title
4. Control Group
Arm Type
Experimental
Arm Description
Participants will not receive any intervention during the research process. They will be given an intervention after the research is completed.
Intervention Type
Drug
Intervention Name(s)
Neurostimulant pharmaceutical drugs
Other Intervention Name(s)
Exercise intervention, Neurostimulants + Exercise intervention, Control Group
Intervention Description
The Pi will only administer the exercise intervention. This will consist of minimum of 8 sessions of group exercises, working on improving muscle tone, core stability, balance, fine and gross motor skills and visual motor integration. The pharmacological therapy will be administered and monitored by medical practitioners, as is the norm with most children diagnosed and treated for ADHD/ADD. Parents of participants will remain responsible entirely for the monitoring of the pharmacological therapy of their children.
Primary Outcome Measure Information:
Title
Inattention, impulsivity and hyperactivity will be rated, using Conners rating scale.
Description
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.
Time Frame
Aproximately 6 months
Secondary Outcome Measure Information:
Title
Motor co-ordination will be rated, using DCD questionnaire
Description
Improvement or regression in symptoms of co ordination, will be rated by the parent, using the Developmental Co-ordination Disorder Questionnaire, pre and post intervention: 15 statements related to co-ordination will be rated on the following scale: 1 (Not at all like child), 2 (A bit like child), 3 (Moderately like child), 4 (Quite a bit like child) and 5 (Extremely like child). The score will be totalled and scores of 55 and above mean that the child does NOT have co-ordination issues, scores below 55 indicate that the child has co-ordination issues.
Time Frame
Aproximately 6 months.
Other Pre-specified Outcome Measures:
Title
Motor co-ordination will be measured using the Movement Assessment Battery for Children
Description
Improvement or regression of motor/co-ordination symptoms, will be tested by the therapist/primary investigator, using the Movement Assessment Battery for Children. 8 age-appropriate motor tests will be administered and scored.A total Motor Impairment score (TOMI) of under 10,5 indicates that the child is fine, scores from 10,5 to 14 indicate that the child is borderline and scores of 14,5 and above indicate definite motor/co-ordination problems.
Time Frame
Aproximately 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela M Dawson, M.Physio
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escombe Primary School
City
Durban
State/Province
Kzn
ZIP/Postal Code
4600
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
I plan to share my protocol, study design, intervention, statistical analysis and results. Pretty much the entire study, once comlpeted.
IPD Sharing Time Frame
Probably in 2019 and can remain available for as long as is allowed and necessary.
IPD Sharing Access Criteria
Clinical trial site.
Citations:
Citation
Nelson et al. (2015) DCD. Medscape: Drugs, diseases and Procedures.
Results Reference
background

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Co Morbid Attention Deficit and Hyperactivity Disorder(ADHD) and Developmental Co Ordination Disorder (DCD)

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