NCT05208255

Brief Summary

The study was prospectively planned and conducted as per protocol. However, registration was completed retrospectively due to administrative oversight. No changes were made to the protocol after study initiation. Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. About one-third of children with ADHD have difficulties with fine and gross motor skills. Motor problems during dynamic balance tasks are more pronounced in these children compared to their typically developing peers. These issues may result from dysfunction in brain regions, possibly linked to delayed cerebellar development. Motor imagery-the mental simulation of movement without actual execution-has been studied as a cause of motor impairments in ADHD and Developmental Coordination Disorder (DCD). While motor imagery deficits are clear in DCD, evidence in ADHD remains unclear. Studies show that motor imagery training, alone or combined with physical exercise, can improve postural control. In children with DCD, motor imagery training improved movement skills. ADHD treatment is multidimensional, including pharmacological and psychosocial interventions. Medications are effective in reducing symptoms and associated behaviors. Physical exercise also helps reduce ADHD symptoms, improving medication response and cognitive functions. This study aims to examine the effects of telerehabilitation-based exercise and motor imagery training on ADHD symptoms and balance in children. Telerehabilitation has become popular due to pandemic-related restrictions, yet no exercise program combining telerehabilitation and motor imagery exists for children with ADHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2024

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

December 29, 2021

Last Update Submit

June 3, 2025

Conditions

Keywords

ADHDTelerehabilitationMotor ImageryBalancePhysiotherapy

Outcome Measures

Primary Outcomes (10)

  • Conners Parent Rating Scale-Revised Short

    It determines the severity of ADHD symptoms. The scale consists of three sub-scales (Oppositional Defiant, Cognitive Problems-Inattention, Hyperactivity) and an auxiliary scale (ADHD Index). The questions are answered by the parents on a four-point Likert scale as "Never", "rarely", "often", and "always" which are scored as "0", "1", "2", and "3", respectively.

    pre-intervention

  • Conners Parent Rating Scale-Revised Short

    It determines the severity of ADHD symptoms. The scale consists of three sub-scales (Oppositional Defiant, Cognitive Problems-Inattention, Hyperactivity) and an auxiliary scale (ADHD Index). The questions are answered by the parents on a four-point Likert scale as "Never", "rarely", "often", and "always" which are scored as "0", "1", "2", and "3", respectively.

    within the first week post-intervention

  • Stroop Test

    The Stroop Test is a task assessing executive function involving processing speed, concentration, and selective attention. Stroop Test was applied in five sections. These sections and related cards are as follows in their application order: (1) The card with the color names printed in black (1st card); (2) the card with the color names printed in different colors (2nd card); (3) the card with the colored printed circles (3rd card); (4) in the card with neutral words without the color name (4th Card); (5) the section where the colors of the words in the 2nd Card are spelt, with the names of colors printed in different colors.

    pre-intervention

  • Stroop Test

    The Stroop Test is a task assessing executive function involving processing speed, concentration, and selective attention. Stroop Test was applied in five sections. These sections and related cards are as follows in their application order: (1) The card with the color names printed in black (1st card); (2) the card with the color names printed in different colors (2nd card); (3) the card with the colored printed circles (3rd card); (4) in the card with neutral words without the color name (4th Card); (5) the section where the colors of the words in the 2nd Card are spelt, with the names of colors printed in different colors.

    within the first week post-intervention

  • d2 Test of Attention

    The d2 Test measures processing speed, rule compliance, and quality of performance, allowing for a neuropsychological estimation of individual attention and concentration performance.

    pre-intervention

  • d2 Test of Attention

    The d2 Test measures processing speed, rule compliance, and quality of performance, allowing for a neuropsychological estimation of individual attention and concentration performance.

    within the first week post-intervention

  • Y Balance Test

    Y-Balance Test is used to evaluate the dynamic balance. YBT is performed in three directions (anterior, posteromedial, and posterolateral).

    pre-intervention

  • Y Balance Test

    Y-Balance Test is used to evaluate the dynamic balance. YBT is performed in three directions (anterior, posteromedial, and posterolateral).

    within the first week post-intervention

  • Timed Up and Go Test

    The Timed Up and Go Test, which is found an excellent level of validity and reproducibility by Nicolini and Donadio, is performed as the standard test protocol applied in children to evaluate dynamic balance and functionality.

    pre-intervention

  • Timed Up and Go Test

    The Timed Up and Go Test, which is found an excellent level of validity and reproducibility by Nicolini and Donadio, is performed as the standard test protocol applied in children to evaluate dynamic balance and functionality.

    within the first week post-intervention

Secondary Outcomes (8)

  • Movement Imagery Questionnaire-Revised Second Edition

    pre-intervention

  • Movement Imagery Questionnaire-Revised Second Edition

    within the first week post-intervention

  • Kinesthetic and Visual Imagery Ouestionnaire

    pre-intervention

  • Kinesthetic and Visual Imagery Ouestionnaire

    within the first week post-intervention

  • Timed Up and Go-Mental Chronometer

    pre-intervention

  • +3 more secondary outcomes

Study Arms (3)

Exercise Group1

EXPERIMENTAL

The telerehabilitation-based neurocognitive exercise group 6 weeks, 2 sessions per week Session duration: 60 minutes

Other: Exercise

Exercise Group2

EXPERIMENTAL

The telerehabilitation-based neurocognitive exercise+motor imagery training group 6 weeks, 2 sessions per week Session duration: 60 minutes (45 minutes-neurocognitive exercise; 15 minutes-motor imagery training)

Other: Exercise

Control Group

ACTIVE COMPARATOR

The medication group - Participants who voluntarily participated in the study but did not want to participate in exercise groups. 6 weeks of medication use

Other: Exercise

Interventions

NEP is a multimodal exercise program including different motor coordination exercises and cognitive tasks. Exercises are progressed from simple to complex tasks. Varied equipment (such as different sized balls, rackets, tulles, exercises balls, eye bands, ropes etc.) is used during different exercises containing cross-limb movements, throwing, jumping, walking, and cognitive tasks. Although the stages of the NEP and exercise selection are the same for each participant, the use of materials or cognitive tasks selection may differ according to the age and skill of the participant. The cognitive tasks were performed by using different visual (colored cards, numbered cards etc.) or auditory cues. Motor Imagery Program: Motor imagery (MI) is a dynamic mental state during which the representation of a given motor movement is rehearsed in working memory without overt motor output. MI training will be performed in the form of imagined NEP exercises in the last 15 minutes of the session.

Also known as: Neurocognitive Exercise Program (NEP)
Control GroupExercise Group1Exercise Group2

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of ADHD
  • Between the ages of 7-12
  • Volunteer
  • Not using psychostimulant drugs for at least two months

You may not qualify if:

  • Having a systemic disease that affects physical assessments
  • Having severe visual impairment (color blindness, strabismus, etc.)
  • Having a neurological disease
  • Having a musculoskeletal disease
  • Having any neuropsychiatric disorder other than Oppositional Defiant Disorder, anxiety disorders, and mood disorders
  • Having Developmental Coordination Disorder
  • Have previously participated in a motor imaging or motor imaging-like study/practice
  • Having an IQ score of 80 and below
  • Being a licensed athlete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research asisstant

Study Record Dates

First Submitted

December 29, 2021

First Posted

January 26, 2022

Study Start

August 15, 2022

Primary Completion

June 15, 2023

Study Completion

February 27, 2024

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations