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CompletedNCT02780102ADHDUpdated Feb 3, 2021

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

An interventional study of Cognitive-Motor Rehabilitation and Ritalin in Attention Deficit Hyperactivity Disorder, sponsored by Allameh Tabatabai University. Completed at 1 site in Iran, Islamic Republic of. Open to male participants aged 9 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by Allameh Tabatabai University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
9 Years to 12 Years
Sex
Male
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Study 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.

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Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • ADHD
  • Cognitive-motor rehabilitation
  • Active Control Group
  • Stimulant Medication
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In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 48 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Allameh Tabatabai University is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Receiving ADHD diagnosis
  • aged between 9 and 12 years
  • Intelligence Quotient (IQ)>90

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Cognitive-Motor Rehabilitation

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

    Other: Cognitive-Motor Rehabilitation

  • Experimental
    Ritalin

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

    Drug: Ritalin

  • Active comparator
    Active Control

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

    Other: Active Control

Interventions

  • OtherCognitive-Motor Rehabilitation

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

  • DrugRitalin

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

    Also known as: drug therapy

  • OtherActive Control

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

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What researchers measure

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

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Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02780102
Lead sponsor
Allameh Tabatabai University
Responsible party
Saeed Azami (Mr., Allameh Tabatabai University) — Principal investigator
First posted
May 23, 2016
Start date
Sep 2015
Primary completion
Mar 2016
Completion
Aug 2017
Last update
Feb 3, 2021

Study contacts

Saeed Azami, PhD
study director · Semnan University
Zeynab AliMadadi, MD
principal investigator · Tehran University of medical Science

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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