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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04697771
Other study ID # E1-20-1038
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 28, 2022

Study information

Verified date February 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized controlled study examining the effect of telerehabilitation on fine motor performance and handwriting difficulties experienced by children with attention deficit hyperactivity disorder.


Description:

It is planned that 40 children between the ages of 6-8 diagnosed with attention deficit and hyperactivity disorder and their families will participate voluntarily. An informed consent form, BOT-2 and Minnesota Handwriting Test will be sent to volunteer participants via e-mail. An evaluation session on Zoom application will be held for each participant with the participation of the occupational therapist, child and family. After the evaluation, the participants will be randomized and allocated to study and control groups. Fine motor skills training will be given to the study group 3 sessions a week. The training will be given on the Zoom application and the duration is 8 weeks. At the end of 8 weeks, the evaluation will be done again with BOT-2 and Minnesota Handwriting Test. The control group will be evaluated with BOT-2 and Minnesota Handwriting Test for the second time after waiting 8 weeks and will receive fine motor skills training.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 28, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility Inclusion Criteria: - To be in the age range of 6-8, - Diagnosed with Attention Deficit Hyperactivity Disorder-Predominantly Inattentive subtype according to DSM-5 and ADHD Rating Scale-5, - Continuing individual education, - After being informed about the study have agreed to participate in the study. Exclusion Criteria: - Children with an additional physical and neurological problem to accompany

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fine Motor Skills Training
The fine motor skills training program was planned for the areas of difficulty that children with ADHD experience in the fine motor area as stated in the literature (Lavasani & Stagnitti, 2011). The fine motor goals were organized for 8 weeks, each week including a different fine motor area and practicing handwriting. For each fine motor goal, 3 different activities were identified that did not require materials or could be practiced with materials that could be easily found in each child's home. For example, for the fine motor strengthening goal, three different activities were planned for the same purpose with tools such as play dough, nails, and staples (Case-Smith & O'Brien, 2013). The activities determined each week were repeated three days a week in the same way and applied to all children. Within the 40-minute session, each activity was performed for 10 minutes under the guidance of an expert occupational therapist.

Locations

Country Name City State
Turkey Hacettepe University Ankara Ankara - Altindag

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minnesota Handwriting Test It evaluates six categories, including legibility, form, alignment, size, spacing, and rate 5 minute
Secondary Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2) The test has been produced as a motor function assessment tool that can be applied to children in a short time.
Fine motor accuracy, fine motor integration, dexterity, bilateral coordination and upper extremity coordination sub-parameters of the test will be applied.
15 minute
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