Attention Deficit Hyperactivity DisorderNCT05902338
Effects of Music on Motor Skills of Children With Attention Deficit and Hyperactivity Disorder
A study testing Music in people with Attention Deficit Hyperactivity Disorder, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Physiotherapists have positive effects on motor skills, executive functions and symptoms of children with attention deficit and hyperactivity disorder. However, progression takes time due to the symptoms of the disease. Physiotherapists need strategies to manage the symptoms of ADHD. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jun 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having been diagnosed with ADHD combined type by a child psychiatrist
- Having adequate cognitive skills to understand the commands of the physiotherapist
Who cannot join
- Having hearing and/or vision problems
- Having any neurological and/or orthopedic problems that would prevent him from performing the tests
- Having a psychiatric disorder other than ADHD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Skills in Children With Attention Deficit and Hyperactivity Disorder
Physiotherapists have positive effects on motor skills, executive functions and symptoms of children with attention deficit and hyperactivity disorder. However, progression takes time due to the symptoms of the disease. Physiotherapists need strategies to manage the symptoms of ADHD. Music can be used as a strategy because music is known to reduce the symptoms of children in this group. There is no study in the literature on how motor skills will be affected with musical accompaniment. The aim of this study is to compare motor skills performed with and without music in children with ADHD. When we evaluate motor skills like in a treatment session, the usability of music as an environmental factor will be investigated according to the positive, negative or ineffective results of the music effect.
Read the detailed description
The American Psychiatric Association defines attention deficit and hyperactivity disorder (ADHD) as one of the most common mental disorders affecting children and adults. The etiology of ADHD is not fully known. Attention deficit, hyperactivity and/or impulsivity are seen as the main symptoms of ADHD. ADHD is grouped into three subtypes according to these symptoms. These three subtypes consist of attention-deficit-dominant type, hyperactivity-dominant type, and combined type with both hyperactivity and inattention symptoms. Researchers reported that 45-70% of children with ADHD have problems in fine and gross motor skills. It is known that problems in motor skills are associated with main symptoms. Balance, gait and postural control are affected in terms of gross motor skills. It has been observed that they perform more slowly in activities that require fine motor skills such as cutting, doing crafts or drawing, and in consecutive finger movements. In addition, handwriting disorders such as dysgraphia are seen in 70% of children with ADHD. During the dual tasks, the sources of attention are divided. Due to this division, the secondary task affects postural performance.
Music is one of the therapy options in some conditions and known as music therapy. It is used in many diseases and conditions such as dementia-alzamer, autism, cerebral palsy, cancer, prematurity, depression and ADHD. Now that music is known to reduce the symptoms of children with ADHD, physical therapists may use music as a strategy. Thus, the purpose of this study is to compare motor skills of children with ADHD with and without music conditions.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Music
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
"L400 Over Ear Music Headset Glowing Cat Ear Headphones 7" branded headphones will be used for musical measurements (70-80 bpm music).
| Study group | Role | What they receive |
|---|---|---|
| Group with music | Experimental | "L400 Over Ear Music Headset Glowing Cat Ear Headphones 7" branded headphones will be used for music intervention. Receives: Other: Music |
| Group without music | No intervention | Music will not be used while performing motor skills. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance
Stork static balance test will be used. Children will be asked to stand comfortably on both feet with their hands on their hips. They will then be asked to raise their non-dominant legs. This test will be repeated 3 times. The test will be measured in time (seconds) with a stopwatch and the best result from three attempts will be recorded.
Measured: change from baseline to after 30-minute from the first measurement
Secondary outcomes (6)
Dynamic balance
Timed up and go (TUG) test will be used. The TUG test is administered using 2 standard chairs and children are asked to walk in a self preferred speed. Time is recorded in seconds.
Measured: change from baseline to after 30-minute from the first measurement
Nine hole peg test
The test consists of a square board with 9 holes. First, the child will be asked to insert the nails into the holes as quickly as possible using the dominant hand, and to quickly remove all the nails from the holes as soon as they are all inserted. Insertion, removal and total time of nails will be recorded in seconds via stopwatch.
Measured: change from baseline to after 30-minute from the first measurement
Blocking with jenga game
Jenga game involves attention and hand eye coordination. The children will be asked to make a standard shape made using six of the game's blocks and the completion time will be recorded in seconds.
Measured: change from baseline to after 30-minute from the first measurement
Puzzle game
A standard wood puzzle will be used to test fine motor skills. The time to complete the puzzle will be recoded in seconds with a stopwatch.
Measured: change from baseline to after 30-minute from the first measurement
Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF)
It consists of composite scores of fine motor control, manual coordination, body coordination, strength and agility motor domain. Scoring is done for each subheading. The maximum score that can be obtained from the entire test is 88.
Measured: change from baseline to after 30-minute from the first measurement
Dual task skill
Dual task is based on distraction while doing two tasks at the same time. Performance decreases in dual tasks due to sharing of attention. For the dual task, the child will carry a water filled bottle (500 ml) in his dominant hand while performing the 10-meter walking test. The dual duty will be calculated with the dual duty cost formula. This formula is as follows;
Dual Task Cost = ((Dual Task Performance - Single Task Performance) X 100/Single Task Performance) The number from calculation will be recorded.
Measured: change from baseline to after 30-minute from the first measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Güçhan, Eastern Mediterranean University
- Investigators
- ZEHRA G TOPCU, Principal investigator, PT. Assoc. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902338
- Sponsor's protocol ID
- ETK2023
- Status last verified
- Jan 2024
- First submitted
- 25 May 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Skills in Children With Attention Deficit and Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05902338
- Acronym / sponsor ID
- ETK2023
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physiotherapists have positive effects on motor skills, executive functions and symptoms of children with attention deficit and hyperactivity disorder. However, progression takes time due to the symptoms of the disease. Physiotherapists need strategies to manage the symptoms of ADHD. Music can be used as a strategy because music is known to reduce the symptoms of children in this group. There is no study in the literature on how motor skills will be affected with musical accompaniment. The aim of this study is to compare motor skills performed with and without music in children with ADHD. When we evaluate motor skills like in a treatment session, the usability of music as an environmental factor will be investigated according to the positive, negative or ineffective results of the music effect.
Detailed description
The American Psychiatric Association defines attention deficit and hyperactivity disorder (ADHD) as one of the most common mental disorders affecting children and adults. The etiology of ADHD is not fully known. Attention deficit, hyperactivity and/or impulsivity are seen as the main symptoms of ADHD. ADHD is grouped into three subtypes according to these symptoms. These three subtypes consist of attention-deficit-dominant type, hyperactivity-dominant type, and combined type with both hyperactivity and inattention symptoms. Researchers reported that 45-70% of children with ADHD have problems in fine and gross motor skills. It is known that problems in motor skills are associated with main symptoms. Balance, gait and postural control are affected in terms of gross motor skills. It has been observed that they perform more slowly in activities that require fine motor skills such as cutting, doing crafts or drawing, and in consecutive finger movements. In addition, handwriting disorders such as dysgraphia are seen in 70% of children with ADHD. During the dual tasks, the sources of attention are divided. Due to this division, the secondary task affects postural performance.
Music is one of the therapy options in some conditions and known as music therapy. It is used in many diseases and conditions such as dementia-alzamer, autism, cerebral palsy, cancer, prematurity, depression and ADHD. Now that music is known to reduce the symptoms of children with ADHD, physical therapists may use music as a strategy. Thus, the purpose of this study is to compare motor skills of children with ADHD with and without music conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with music | Experimental | Other: Music"L400 Over Ear Music Headset Glowing Cat Ear Headphones 7" branded headphones will be used for music intervention. |
| Group without music | No intervention | –Music will not be used while performing motor skills. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Having been diagnosed with ADHD combined type by a child psychiatrist
- Having adequate cognitive skills to understand the commands of the physiotherapist
Key exclusion criteria (3 listed)
- Having hearing and/or vision problems
- Having any neurological and/or orthopedic problems that would prevent him from performing the tests
- Having a psychiatric disorder other than ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music"L400 Over Ear Music Headset Glowing Cat Ear Headphones 7" branded headphones will be used for musical measurements (70-80 bpm music). | Other | Group with music |
Primary outcome
Static balance
Time frame: change from baseline to after 30-minute from the first measurement
Stork static balance test will be used. Children will be asked to stand comfortably on both feet with their hands on their hips. They will then be asked to raise their non-dominant legs. This test will be repeated 3 times. The test will be measured in time (seconds) with a stopwatch and the best result from three attempts will be recorded.
6 secondary outcomes
Dynamic balance
Time frame: change from baseline to after 30-minute from the first measurement
Nine hole peg test
Time frame: change from baseline to after 30-minute from the first measurement
Blocking with jenga game
Time frame: change from baseline to after 30-minute from the first measurement
Puzzle game
Time frame: change from baseline to after 30-minute from the first measurement
Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF)
Time frame: change from baseline to after 30-minute from the first measurement
Dual task skill
Time frame: change from baseline to after 30-minute from the first measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Hyperactivity Disorder
RecruitingObservational study
National Pregnancy Registry for Psychiatric Medications
Pregnant Women, Psychotropic Drugs
Recruiting
Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
Attention Deficit Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZEHRA G TOPCU principal investigator
PT. Assoc. Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Attention Deficit Hyperactivity Disorder, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance (time frame: change from baseline to after 30-minute from the first measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.