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

NCT ID: NCT02780102

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive-Motor Rehabilitation

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

Group Type EXPERIMENTAL

Cognitive-Motor Rehabilitation

Intervention Type OTHER

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

Ritalin

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

Group Type EXPERIMENTAL

Ritalin

Intervention Type DRUG

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

Active Control

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

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type OTHER

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

Interventions

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Cognitive-Motor Rehabilitation

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

Intervention Type OTHER

Ritalin

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

Intervention Type DRUG

Active Control

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

Intervention Type OTHER

Other Intervention Names

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drug therapy

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Allameh Tabatabai University

OTHER

Sponsor Role lead

Responsible Party

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Saeed Azami

Mr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saeed Azami, PhD

Role: STUDY_DIRECTOR

Semnan University

Zeynab AliMadadi, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran University of medical Science

Locations

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

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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328/94/16090

Identifier Type: -

Identifier Source: org_study_id

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