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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cognitive-Motor Rehabilitation
Ritalin
Active Control
Sponsored by
Allameh Tabatabai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Cognitive-motor rehabilitation, Active Control Group, Stimulant Medication

Eligibility Criteria

9 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Cognitive-Motor Rehabilitation

Ritalin

Active Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)
Span board task from the Lumosity.com online brain training software
Listening span task (L.SPAN)
Stroop color-word test
Tower of London test (TOL)
Restricted academic situation scale (RASS)
Arithmetic task from WISC-IV testing battery
Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)
Dictation and Spelling examination

Secondary Outcome Measures

Full Information

First Posted
May 19, 2016
Last Updated
February 2, 2021
Sponsor
Allameh Tabatabai University
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1. Study Identification

Unique Protocol Identification Number
NCT02780102
Brief Title
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
Acronym
ADHD
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allameh Tabatabai University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Cognitive-motor rehabilitation, Active Control Group, Stimulant Medication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Motor Rehabilitation
Arm Type
Experimental
Arm Description
Cognitive-Motor Rehabilitation (CMR): 20 sixty-minute sessions of cognitive-motor rehabilitation
Arm Title
Ritalin
Arm Type
Experimental
Arm Description
2 to 3 doses of 10 mg Ritalin tablets per day during 8 week.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises
Intervention Type
Other
Intervention Name(s)
Cognitive-Motor Rehabilitation
Intervention Description
Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises
Intervention Type
Drug
Intervention Name(s)
Ritalin
Other Intervention Name(s)
drug therapy
Intervention Description
2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.
Intervention Type
Other
Intervention Name(s)
Active Control
Intervention Description
Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises
Primary Outcome Measure Information:
Title
Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)
Time Frame
12 months
Title
Span board task from the Lumosity.com online brain training software
Time Frame
12 months
Title
Listening span task (L.SPAN)
Time Frame
12 months
Title
Stroop color-word test
Time Frame
12 months
Title
Tower of London test (TOL)
Time Frame
12 months
Title
Restricted academic situation scale (RASS)
Time Frame
12 months
Title
Arithmetic task from WISC-IV testing battery
Time Frame
12 months
Title
Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)
Time Frame
12 months
Title
Dictation and Spelling examination
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeed Azami, PhD
Organizational Affiliation
Semnan University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zeynab AliMadadi, MD
Organizational Affiliation
Tehran University of medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Counseling and guidence Center of the Department of education of region 9 of Tehran
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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