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The Effect of Non-pharmacological Novel Cognitive Interventions on Motor-Cognitive Function in Children With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Virtual Reality training
Computerized Cognitive Remediation
Standard of care
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children diagnosed with ADHD by a pediatrician, child neurologist or child psychiatrist, according to the ADHD criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition.
  • Attending regular education frameworks
  • Have access to a personal computer at home

Exclusion Criteria:

  • Children on active medication for ADHD during the study period
  • Are taking any other medication that could affect attention, balance or motor function
  • Have a serious medical condition that could affect attention, gait or balance
  • Have any known genetic syndromes, autism, neurological conditions or psychiatric disorders or any medical illness requiring immediate treatment
  • Are participating in a competing exercise program designed to improve gait or balance

Sites / Locations

  • Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Virtual Reality training

Computerized Cognitive Remediation

Control group

Arm Description

Subjects will be asked to walk on a treadmill while negotiating virtual obstacles. The VR system includes a camera based motion capture and a computer generated simulation. The camera is used to capture the movement of the participant's feet. These images are then transferred to the computer simulation and projected to the patient on a screen. The speed, orientation, size, frequency of appearance and shape of the targets are manipulated to increase task difficulty. The Virtual environment imposes a cognitive load requiring attention and response selection as well as processing of rich visual stimuli involving several perceptual processes. The system provides visual and auditory feedback of task performance to enhance motor learning.

The "AttenGo" program will be used for neuro-cognitive remediation aimed at enhancing attention, concentration, working memory, and executive function. The program has shown to be effective in improving attention and executive function in children with ADHD. The training is composed of cognitive exercises that challenge subjects with problem solving, information processing, response inhibition and dividing attention. The users receive immediate feedback from the system when losing focus. The program is adaptive and progresses according to the subjects abilities.

Subjects in this group will be assessed based on the study protocol but will receive no treatment other than their standard of care which could include pharmacological or/ and non-pharmacological treatment.

Outcomes

Primary Outcome Measures

Immediate change in gait function
Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
Immediate change in cognitive function
A computerized neuropsychological test battery will be used to assess different cognitive domains including memory, attention, executive function, visual spatial processing and a global cognitive composite score. These measures will be compared to baseline performance.

Secondary Outcome Measures

Retention of change in gait function
Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared performance at baseline and at one week post intervention.
Retention of change in cognitive function
A computerized neuropsychological test battery will be used to assess different cognitive domains including memory, attention, executive function, visual spatial processing and a global cognitive composite score. These measures will be compared performance at baseline and at one week post intervention.

Full Information

First Posted
February 15, 2014
Last Updated
February 23, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02071186
Brief Title
The Effect of Non-pharmacological Novel Cognitive Interventions on Motor-Cognitive Function in Children With ADHD
Official Title
The Effect of Non-pharmacological Novel Cognitive Interventions on Motor-Cognitive Function in Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test the hypothesis that cognitive remediation and virtual reality treatment approaches can enhance cognitive and motor function in children with ADHD.
Detailed Description
Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurobehavioral disorder affecting children. ADHD is currently treated with a combination of medication and behavioral therapy aimed at reducing the negative symptoms. Pharmacologic treatment methods, such as the use of Methylphenidate (MPH) have many drawbacks including high cost and side effects. Non-pharmacological treatment approaches teach strategies aimed at improving behavior and environmental management. Evidence on efficacy of these treatments is lacking and the literature only supports the 'parental education' approach. Motor aspects of the disorder tend to be undertreated. Studies have shown that persistent use of MPH has a positive effect on motor output timing and coordination in children with ADHD. Thus non-pharmacological interventions aimed at improving attention are likely to also improve other aspects of the disorder such as motor problems and thus should be further explored. Various computerized remediation programs have been developed as a non-pharmacological alternative for children with ADHD. The programs present exercises that require sustained attention and a response to set rules and are often graded in task complexity according to the user's abilities. Virtual Reality (VR) is a simulation of the real world using computer graphics that requires interaction, immersion and active participation by the user. VR applications have shown to be effective in improving attention in children and adolescents with behavioral problems, teaching them to focus on some tasks more than existing cognitive training programs. VR while walking has demonstrated improvements in both motor and cognitive function in older adults and patients with neurodegenerative diseases suggesting a beneficial effect on motor and cognitive function. However this treatment has not been tested yet in ADHD. The study will investigate the following aims: To compare the effect of computerized cognitive remediation and VR on attention and gait in children with ADHD. To examine the long term effects of computerized cognitive remediation and VR on attention and gait in children with ADHD. To compare, in an exploratory analysis, the effects of the non-pharmacological training paradigms to standard of care treatment on attention and gait in 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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality training
Arm Type
Experimental
Arm Description
Subjects will be asked to walk on a treadmill while negotiating virtual obstacles. The VR system includes a camera based motion capture and a computer generated simulation. The camera is used to capture the movement of the participant's feet. These images are then transferred to the computer simulation and projected to the patient on a screen. The speed, orientation, size, frequency of appearance and shape of the targets are manipulated to increase task difficulty. The Virtual environment imposes a cognitive load requiring attention and response selection as well as processing of rich visual stimuli involving several perceptual processes. The system provides visual and auditory feedback of task performance to enhance motor learning.
Arm Title
Computerized Cognitive Remediation
Arm Type
Experimental
Arm Description
The "AttenGo" program will be used for neuro-cognitive remediation aimed at enhancing attention, concentration, working memory, and executive function. The program has shown to be effective in improving attention and executive function in children with ADHD. The training is composed of cognitive exercises that challenge subjects with problem solving, information processing, response inhibition and dividing attention. The users receive immediate feedback from the system when losing focus. The program is adaptive and progresses according to the subjects abilities.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Subjects in this group will be assessed based on the study protocol but will receive no treatment other than their standard of care which could include pharmacological or/ and non-pharmacological treatment.
Intervention Type
Device
Intervention Name(s)
Virtual Reality training
Intervention Description
Subjects will train with the VR system at the Tel Aviv Sourasky Medical Center 3 times per week for 6 weeks with each session lasting approximately 30 minutes. To assure participants' safety and maintaining progress, training with the VR will be individual and provided by qualified physiotherapists, who use the system on a daily basis.
Intervention Type
Other
Intervention Name(s)
Computerized Cognitive Remediation
Intervention Description
Subjects in this study will train with the AttenGo program at home 3-5 times per week for 6 weeks with each session lasting approximately 30 minutes.
Intervention Type
Other
Intervention Name(s)
Standard of care
Primary Outcome Measure Information:
Title
Immediate change in gait function
Description
Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
Time Frame
One week post intervention
Title
Immediate change in cognitive function
Description
A computerized neuropsychological test battery will be used to assess different cognitive domains including memory, attention, executive function, visual spatial processing and a global cognitive composite score. These measures will be compared to baseline performance.
Time Frame
One week post intervention
Secondary Outcome Measure Information:
Title
Retention of change in gait function
Description
Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared performance at baseline and at one week post intervention.
Time Frame
One month post intervention
Title
Retention of change in cognitive function
Description
A computerized neuropsychological test battery will be used to assess different cognitive domains including memory, attention, executive function, visual spatial processing and a global cognitive composite score. These measures will be compared performance at baseline and at one week post intervention.
Time Frame
One month post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children diagnosed with ADHD by a pediatrician, child neurologist or child psychiatrist, according to the ADHD criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition. Attending regular education frameworks Have access to a personal computer at home Exclusion Criteria: Children on active medication for ADHD during the study period Are taking any other medication that could affect attention, balance or motor function Have a serious medical condition that could affect attention, gait or balance Have any known genetic syndromes, autism, neurological conditions or psychiatric disorders or any medical illness requiring immediate treatment Are participating in a competing exercise program designed to improve gait or balance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Leitner, MD
Email
leitnery@tlvmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Anat Mirelman, PhD
Email
anatmi@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Leitner, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anat Mirelman, PhD
Email
anatmi@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Yael Leitner, MD
First Name & Middle Initial & Last Name & Degree
Anat Mirelman, PhD

12. IPD Sharing Statement

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The Effect of Non-pharmacological Novel Cognitive Interventions on Motor-Cognitive Function in Children With ADHD

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