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

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Counseling and guidence Center of the Department of education of region 9 of Tehran

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
Other: Cognitive-Motor Rehabilitation
Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises
EXPERIMENTAL: Ritalin
2 to 3 doses of 10 mg Ritalin tablets per day during 8 week.
Drug: Ritalin
2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.
Other Names:
  • drug therapy
ACTIVE_COMPARATOR: Active Control
Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises
Other: Active Control
Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises

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
12 months
Span board task from the Lumosity.com online brain training software
Time Frame: 12 months
12 months
Listening span task (L.SPAN)
Time Frame: 12 months
12 months
Stroop color-word test
Time Frame: 12 months
12 months
Tower of London test (TOL)
Time Frame: 12 months
12 months
Restricted academic situation scale (RASS)
Time Frame: 12 months
12 months
Arithmetic task from WISC-IV testing battery
Time Frame: 12 months
12 months
Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)
Time Frame: 12 months
12 months
Dictation and Spelling examination
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allameh Tabatabai University

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

Keywords

Additional Relevant MeSH Terms

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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