NCT05902338

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

May 25, 2023

Last Update Submit

January 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Dynamic balance

    change from baseline to after 30-minute from the first measurement

  • Nine hole peg test

    change from baseline to after 30-minute from the first measurement

  • Blocking with jenga game

    change from baseline to after 30-minute from the first measurement

  • Puzzle game

    change from baseline to after 30-minute from the first measurement

  • Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF)

    change from baseline to after 30-minute from the first measurement

  • +1 more secondary outcomes

Study Arms (2)

Group with music

EXPERIMENTAL

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

Other: Music

Group without music

NO INTERVENTION

Music will not be used while performing motor skills.

Interventions

MusicOTHER

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

Group with music

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private clinics

Nicosia, Cyprus

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • ZEHRA G TOPCU

    PT. Assoc. Prof.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT Assoc Prof

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 15, 2023

Study Start

June 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 15, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations