Attention Deficit Hyperactivity DisorderADHDNCT02780102
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
A study testing Cognitive-Motor Rehabilitation and Ritalin in people with Attention Deficit Hyperactivity Disorder, run by Allameh Tabatabai University at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 9 to 12 years, men only
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Cognitive-Motor Rehabilitation and Ritalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- Sep 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Receiving ADHD diagnosis
- aged between 9 and 12 years
- Intelligence Quotient (IQ)>90
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Counseling and guidence Center of the Department of education of region 9 of Tehran
Tehran
About this study
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
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Cognitive-Motor Rehabilitation, Ritalin, Active Control
- Keywords
- ADHD, Cognitive-motor rehabilitation, Active Control Group, Stimulant Medication
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Motor RehabilitationOther
Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises
RitalinDrug
Also called drug therapy
2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.
Active ControlOther
Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Motor Rehabilitation | Experimental | Cognitive-Motor Rehabilitation (CMR): 20 sixty-minute sessions of cognitive-motor rehabilitation Receives: Other: Cognitive-Motor Rehabilitation |
| Ritalin | Experimental | 2 to 3 doses of 10 mg Ritalin tablets per day during 8 week. Receives: Drug: Ritalin |
| Active Control | Active comparator | Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)
Measured: 12 months
Span board task from the Lumosity.com online brain training software
Measured: 12 months
Listening span task (L.SPAN)
Measured: 12 months
Stroop color-word test
Measured: 12 months
Tower of London test (TOL)
Measured: 12 months
Restricted academic situation scale (RASS)
Measured: 12 months
Arithmetic task from WISC-IV testing battery
Measured: 12 months
Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)
Measured: 12 months
Dictation and Spelling examination
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allameh Tabatabai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeed Azami, Allameh Tabatabai University
- Investigators
- Saeed Azami, PhD, Study director, Semnan UniversityZeynab AliMadadi, MD, Principal investigator, Tehran University of medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780102
- Sponsor's protocol ID
- 328/94/16090
- Acronym
- ADHD
- Status last verified
- Feb 2021
- First submitted
- 19 May 2016
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02780102
- Acronym / sponsor ID
- ADHD / 328/94/16090
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Cognitive-motor rehabilitation, Active Control Group, Stimulant Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Allameh Tabatabai UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Motor Rehabilitation | Experimental | Other: Cognitive-Motor RehabilitationCognitive-Motor Rehabilitation (CMR): 20 sixty-minute sessions of cognitive-motor rehabilitation |
| Ritalin | Experimental | Drug: Ritalin2 to 3 doses of 10 mg Ritalin tablets per day during 8 week. |
| Active Control | Active comparator | Other: Active ControlActive Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Receiving ADHD diagnosis
- aged between 9 and 12 years
- Intelligence Quotient (IQ)>90
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Motor RehabilitationCognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises | Other | Cognitive-Motor Rehabilitation |
| RitalinAlso: drug therapy2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week. | Drug | Ritalin |
| Active ControlActive Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises | Other | Active Control |
Primary outcome
Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)
Time frame: 12 months
Span board task from the Lumosity.com online brain training software
Time frame: 12 months
Listening span task (L.SPAN)
Time frame: 12 months
Stroop color-word test
Time frame: 12 months
Tower of London test (TOL)
Time frame: 12 months
Restricted academic situation scale (RASS)
Time frame: 12 months
Arithmetic task from WISC-IV testing battery
Time frame: 12 months
Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)
Time frame: 12 months
Dictation and Spelling examination
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saeed Azami, PhD study director
Semnan University
Zeynab AliMadadi, MD principal investigator
Tehran University of medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Motor Rehabilitation and Ritalin in people with Attention Deficit Hyperactivity Disorder, run by Allameh Tabatabai University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV) (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.