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Clinical Trials/NCT02780102
NCT02780102
Completed
Not Applicable

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

Allameh Tabatabai University1 site in 1 country48 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Cognitive-Motor Rehabilitation
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Allameh Tabatabai University
Enrollment
48
Locations
1
Primary Endpoint
Arithmetic task from WISC-IV testing battery
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
August 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Allameh Tabatabai University
Responsible Party
Principal Investigator
Principal Investigator

Saeed Azami

Mr.

Allameh Tabatabai University

Eligibility Criteria

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

Arms & Interventions

Cognitive-Motor Rehabilitation

Cognitive-Motor Rehabilitation (CMR): 20 sixty-minute sessions of cognitive-motor rehabilitation

Intervention: Cognitive-Motor Rehabilitation

Ritalin

2 to 3 doses of 10 mg Ritalin tablets per day during 8 week.

Intervention: Ritalin

Active Control

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

Intervention: Active Control

Outcomes

Primary Outcomes

Arithmetic task from WISC-IV testing battery

Time Frame: 12 months

Dictation and Spelling examination

Time Frame: 12 months

Stroop color-word test

Time Frame: 12 months

Tower of London test (TOL)

Time Frame: 12 months

Restricted academic situation scale (RASS)

Time Frame: 12 months

Listening span task (L.SPAN)

Time Frame: 12 months

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

Time Frame: 12 months

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

Time Frame: 12 months

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

Time Frame: 12 months

Study Sites (1)

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