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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05902338
Other study ID # ETK2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date January 15, 2024

Study information

Verified date January 2024
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date January 15, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

Intervention

Other:
Music
"L400 Over Ear Music Headset Glowing Cat Ear Headphones 7" branded headphones will be used for musical measurements (70-80 bpm music).

Locations

Country Name City State
Cyprus Private clinics Nicosia

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. change from baseline to after 30-minute from the first measurement
Secondary 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. change from baseline to after 30-minute from the first measurement
Secondary 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. change from baseline to after 30-minute from the first measurement
Secondary 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. change from baseline to after 30-minute from the first measurement
Secondary 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. change from baseline to after 30-minute from the first measurement
Secondary 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. change from baseline to after 30-minute from the first measurement
Secondary 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.
change from baseline to after 30-minute from the first measurement
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