- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06798337
Reward Effects on Cognition, Motor Skills, and Motivation in Children (ADHD)
The Effect of Reward on Cognitive Functioning, Motor Skills, and Motivation in 8- to 10-Year-Old Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Overview
Status
Intervention / Treatment
Detailed Description
Research problem: children with Attention-Deficit/Hyperactivity Disorder (ADHD) are inattentive and distractible, which often makes it difficult for physiotherapists to keep them interested, as prolonged activity often causes boredom.
The aim of this study was to determine the effects of reward on cognitive function, motor skills and motivation in 8-10 year old children with ADHD after 3 and 6 week interventions.
Objectives of the study:
1. To compare the cognitive function of children receiving conventional physiotherapy with that of children receiving reward therapy. 2. To compare the motor skills of the children receiving conventional physiotherapy with those of the children receiving the reward. 3. To compare the motivation of children receiving conventional physiotherapy with that of children receiving rewards.
The hypothesis of the study is that exercise with rewards improves cognitive function, motor skills and motivation better than conventional physiotherapy in children aged 8 to 10 years with attention deficit disorder.
Research methods: the study included 60 boys diagnosed with ADHD. Age: 8-10 years. Subjects were randomly divided into reward and conventional physiotherapy groups. In both groups, subjects performed exercises for balance and coordination for 3 times per week for 45 min, but in one group subjects received a reward using virtual reality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaunas, Lithuania, 44221
- Department of health promotion and rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Conventional outpatient PT group (n=30).
Conventional outpatient PT group received typical physical exercises with duration of 6 weeks
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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.
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Experimental: Reward-based PT group
This group received reward based virtual reality exercises with duration of 6 weeks.
Reward was extra exercises using virtual reality
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static balance
Time Frame: At baseline and after 6 weeks
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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.
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At baseline and after 6 weeks
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Attention task with spatial numbers
Time Frame: At baseline and after 6 weeks
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Number of mistakes and Speed coefficient was recorded.
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At baseline and after 6 weeks
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Attention task with spatial figures
Time Frame: At baseline and after 6 weeks
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Number of mistakes and Speed coefficient was recorded.
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At baseline and after 6 weeks
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Easy figural memory task
Time Frame: At baseline and after 6 weeks
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Number of mistakes and Speed coefficient was recorded.
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At baseline and after 6 weeks
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Hard figural memory task
Time Frame: At baseline and after 6 weeks
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Number of mistakes and Speed coefficient was recorded.
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At baseline and after 6 weeks
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Visuo-Constructional Ability task
Time Frame: At baseline and after 6 weeks
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Number of successful attempts and duration (in seconds) was recorded
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At baseline and after 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric motivation Scale (PMot)
Time Frame: At baseline and after 6 weeks
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Participants were instructed to respond to the questions by selecting a visual image that best represented their emotional state.
Each visual image was assigned a numerical value, ranging from 1 (very poor) to 6 (excellent), for statistical data analysis and outcome evaluation (numeric value).
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At baseline and after 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vilma VD Dudoniene, PhD, Lithuanian Sports University
- Study Chair: Vilma Dudoniene, PhD, Lithuanian Sports University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lithuanian Sports University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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