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临床试验/NCT03595826
NCT03595826已完成不适用

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 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2018年5月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
151
试验地点
1
主要终点
Inattention, impulsivity and hyperactivity will be rated, using Conners rating scale.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

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

入排标准

年龄范围
8 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: 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.

干预措施: Neurostimulant pharmaceutical drugs (Drug)

3. Neurostimulants + Exercise intervention

Experimental

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

干预措施: 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.

干预措施: Neurostimulant pharmaceutical drugs (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

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

研究者

发起方
University of KwaZulu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pam Dawson

Principal Investigator

University of KwaZulu

研究点 (1)

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