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

NCT02071186 | Unknown

• 1 other identifier: TASMC-13-YL-0544-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  One week post intervention

• 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.

  One week post intervention

Secondary Outcomes (2)

• Retention of change in gait function

  One month post intervention

• Retention of change in cognitive function

  One month post intervention

Study Arms (3)

Virtual Reality training

EXPERIMENTAL

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.

Device: Virtual Reality training

Computerized Cognitive Remediation

EXPERIMENTAL

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.

Other: Computerized Cognitive Remediation

Control group

ACTIVE COMPARATOR

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.

Other: Standard of care

Interventions

Virtual Reality training DEVICE

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.

Virtual Reality training

Computerized Cognitive Remediation OTHER

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.

Computerized Cognitive Remediation

Standard of care OTHER

Control group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yael Leitner, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Leitner, MD

CONTACT

leitnery@tlvmc.gov.il

Anat Mirelman, PhD

CONTACT

anatmi@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2014
• First Posted: February 25, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

IL (1)