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Completed

NCT Number: NCT02780102

Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

9 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Counseling and guidence Center of the Department of education of region 9 of Tehran

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Motor Rehabilitation

Other

Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises

Ritalin

Drug

2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.

Other names: drug therapy

Active Control

Other

Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises

Primary outcomes

  1. Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)

    Time frame: 12 months

  2. Span board task from the Lumosity.com online brain training software

    Time frame: 12 months

  3. Listening span task (L.SPAN)

    Time frame: 12 months

  4. Stroop color-word test

    Time frame: 12 months

  5. Tower of London test (TOL)

    Time frame: 12 months

  6. Restricted academic situation scale (RASS)

    Time frame: 12 months

  7. Arithmetic task from WISC-IV testing battery

    Time frame: 12 months

  8. Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)

    Time frame: 12 months

  9. Dictation and Spelling examination

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Allameh Tabatabai University

Other

Registry information

Official study title

Comparison of the Effects of Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control on Executive Functions and Clinical Symptoms of Attention Deficit/ Hyperactivity Disorder

Acronym: ADHD

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 23, 2016
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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