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

Attention Deficit Hyperactivity Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780102
• Other study ID #: 328/94/16090
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: August 2017

Study information

• Verified date: February 2021
• Source: Allameh Tabatabai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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

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

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Counseling and guidence Center of the Department of education of region 9 of Tehran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Allameh Tabatabai University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)		12 months
Primary	Span board task from the Lumosity.com online brain training software		12 months
Primary	Listening span task (L.SPAN)		12 months
Primary	Stroop color-word test		12 months
Primary	Tower of London test (TOL)		12 months
Primary	Restricted academic situation scale (RASS)		12 months
Primary	Arithmetic task from WISC-IV testing battery		12 months
Primary	Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)		12 months
Primary	Dictation and Spelling examination		12 months