- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02780102
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD (ADHD)
February 2, 2021 updated by: Saeed Azami, Allameh Tabatabai University
Comparison of the Effects of Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control on Executive Functions and Clinical Symptoms of Attention Deficit/ Hyperactivity Disorder
The investigators administered a randomized controlled trial (RCT) through random assignment of children with ADHD into three different groups to compare the effects of cognitive-motor rehabilitation, immediate release methylphenidate, and an active control on the executive functioning, learning, and behavioral symptoms of children with ADHD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tehran, Iran, Islamic Republic of
- Counseling and guidence Center of the Department of education of region 9 of Tehran
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 12 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Receiving ADHD diagnosis
- aged between 9 and 12 years
- Intelligence Quotient (IQ)>90
Exclusion Criteria:
- Severe co-morbid disorders, such as depression, op-positional defiant disorder and conduct disorder
- A history of seizures during past 2 years
- Disability or handicap preventing the child from participating cognitive-motor exercises
- Sever medical conditions requiring immediate medical treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cognitive-Motor Rehabilitation
Cognitive-Motor Rehabilitation (CMR): 20 sixty-minute sessions of cognitive-motor rehabilitation
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Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises
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EXPERIMENTAL: Ritalin
2 to 3 doses of 10 mg Ritalin tablets per day during 8 week.
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2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.
Other Names:
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ACTIVE_COMPARATOR: Active Control
Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises
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Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)
Time Frame: 12 months
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12 months
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Span board task from the Lumosity.com online brain training software
Time Frame: 12 months
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12 months
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Listening span task (L.SPAN)
Time Frame: 12 months
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12 months
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Stroop color-word test
Time Frame: 12 months
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12 months
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Tower of London test (TOL)
Time Frame: 12 months
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12 months
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Restricted academic situation scale (RASS)
Time Frame: 12 months
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12 months
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Arithmetic task from WISC-IV testing battery
Time Frame: 12 months
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12 months
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Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)
Time Frame: 12 months
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12 months
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Dictation and Spelling examination
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Saeed Azami, PhD, Semnan University
- Principal Investigator: Zeynab AliMadadi, MD, tehran university of medical science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
August 1, 2017
Study Registration Dates
First Submitted
May 19, 2016
First Submitted That Met QC Criteria
May 20, 2016
First Posted (ESTIMATE)
May 23, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 3, 2021
Last Update Submitted That Met QC Criteria
February 2, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- 328/94/16090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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