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Effects of Music on Motor Skills of Children With Attention Deficit and Hyperactivity Disorder

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Music
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Having been diagnosed with ADHD combined type by a child psychiatrist Having adequate cognitive skills to understand the commands of the physiotherapist Exclusion Criteria: 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

Sites / Locations

  • Private clinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group with music

Group without music

Arm Description

"L400 Over Ear Music Headset Glowing Cat Ear Headphones 7" branded headphones will be used for music intervention.

Music will not be used while performing motor skills.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 25, 2023
Last Updated
June 12, 2023
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT05902338
Brief Title
Effects of Music on Motor Skills of Children With Attention Deficit and Hyperactivity Disorder
Official Title
Motor Skills in Children With Attention Deficit and Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group with music
Arm Type
Experimental
Arm Description
"L400 Over Ear Music Headset Glowing Cat Ear Headphones 7" branded headphones will be used for music intervention.
Arm Title
Group without music
Arm Type
No Intervention
Arm Description
Music will not be used while performing motor skills.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
"L400 Over Ear Music Headset Glowing Cat Ear Headphones 7" branded headphones will be used for musical measurements (70-80 bpm music).
Primary Outcome Measure Information:
Title
Static balance
Description
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.
Time Frame
change from baseline to after 30-minute from the first measurement
Secondary Outcome Measure Information:
Title
Dynamic balance
Description
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.
Time Frame
change from baseline to after 30-minute from the first measurement
Title
Nine hole peg test
Description
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.
Time Frame
change from baseline to after 30-minute from the first measurement
Title
Blocking with jenga game
Description
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.
Time Frame
change from baseline to after 30-minute from the first measurement
Title
Puzzle game
Description
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.
Time Frame
change from baseline to after 30-minute from the first measurement
Title
Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF)
Description
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.
Time Frame
change from baseline to after 30-minute from the first measurement
Title
Dual task skill
Description
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.
Time Frame
change from baseline to after 30-minute from the first measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having been diagnosed with ADHD combined type by a child psychiatrist Having adequate cognitive skills to understand the commands of the physiotherapist Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZEHRA G TOPCU
Phone
+903926303067
Ext
2496
Email
zehra.guchan@emu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
GÜVEN ÖZALP, PT
Email
guoz0325@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZEHRA G TOPCU
Organizational Affiliation
PT. Assoc. Prof.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private clinics
City
Nicosia
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZEHRA G TOPCU, Assoc.Prof

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Music on Motor Skills of Children With Attention Deficit and Hyperactivity Disorder

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