NCT06798337

Brief Summary

This interventional study aimed to aimed to evaluate the effects of rewards on cognitive function, motor skills, and motivation in 8- to 10-year-old children with ADHD following 3- and 6-week interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

January 15, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

attentionmotor skillsmotivationreward-based therapy

Outcome Measures

Primary Outcomes (6)

  • Static balance

    was assessed with The Abili Balance Analyzer platform. The software associated with the platform provided an overall stability index based on the tests conducted: Very Good: 0.8; Good: 0.8 to 1.8; Poor: \>1.8.

    At baseline and after 6 weeks

  • Attention task with spatial numbers

    Number of mistakes and Speed coefficient was recorded.

    At baseline and after 6 weeks

  • Attention task with spatial figures

    Number of mistakes and Speed coefficient was recorded.

    At baseline and after 6 weeks

  • Easy figural memory task

    Number of mistakes and Speed coefficient was recorded.

    At baseline and after 6 weeks

  • Hard figural memory task

    Number of mistakes and Speed coefficient was recorded.

    At baseline and after 6 weeks

  • Visuo-Constructional Ability task

    Number of successful attempts and duration (in seconds) was recorded

    At baseline and after 6 weeks

Secondary Outcomes (1)

  • Pediatric motivation Scale (PMot)

    At baseline and after 6 weeks

Study Arms (2)

Conventional outpatient PT group (n=30).

EXPERIMENTAL

Conventional outpatient PT group received typical physical exercises with duration of 6 weeks

Other: Conventional Physiotherapy group

Reward-based PT group

EXPERIMENTAL

This group received reward based virtual reality exercises with duration of 6 weeks. Reward was extra exercises using virtual reality

Other: Reward based physiotherapy group

Interventions

Participants in the regular physical therapy group performed balance and coordination exercises three times a week without the use of rewards. These subjects completed only physical exercises, without engaging in game-like interactive tasks using virtual reality (VR) glasses. Each session was conducted at the same time for each subject, with a potential variation of ±1 hour.

Conventional outpatient PT group (n=30).

Subjects in the reward group performed balance and coordination exercises three times a week, with the inclusion of rewards. At the end of each exercise session, participants engaged in game-like interactive tasks using virtual reality (VR) glasses. Exercise sessions were conducted at the same time for each subject, with a permissible variation of ±1 hour.

Reward-based PT group

Eligibility Criteria

Age8 Years - 10 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBoys were invited to participate in the study.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of ADHD confirmed by a neurologist;
  • male gender;
  • age between 8 and 10 years.
  • ability to read and write;
  • patient's willingness to attend physiotherapy sessions;

You may not qualify if:

  • claustrophobia;
  • neurological disorders (e.g., autism spectrum disorder, depression, obsessive-compulsive disorder, Tourette's syndrome);
  • chronic medical conditions (e.g., cancer, diabetes, cardiovascular diseases);
  • previous treatment for ADHD (e.g., pharmacological therapy, cognitive behavioral therapy) within the last six months;
  • Medication use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of health promotion and rehabilitation

Kaunas, 44221, Lithuania

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Vilma VD Dudoniene, PhD

    Lithuanian Sports University

    PRINCIPAL INVESTIGATOR
  • Vilma Dudoniene, PhD

    Lithuanian Sports University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Reword group did not know about conventional PT group and vice versa.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Qualitative research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof. dr.

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 29, 2025

Study Start

January 15, 2023

Primary Completion

January 15, 2024

Study Completion

May 15, 2024

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The consent form of the informed person states that the individual data of the subjects will not be disclosed, but can only be used to summarized.

Locations