- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697771
Effect of Telerehabilitation on Handwriting Performance in Children With ADHD: RCT
The Effect of Telerahabilitation on Fine Motor Skills and Writing Performance in Children With Attention Deficit and Hyperactivity Disorder: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara - Altındağ
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Ankara, Ankara - Altındağ, Turkey, 06
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
First Evaluation - Fine Motor Skills Training - 8 week - 3 session per week - 40 minute per session - Second Evaluation
|
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.
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No Intervention: Control Group
First Evaluation - 8 week waiting period - Second Evaluation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minnesota Handwriting Test
Time Frame: 5 minute
|
It evaluates six categories, including legibility, form, alignment, size, spacing, and rate
|
5 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2)
Time Frame: 15 minute
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hakan Öğütlü, Msc, Ankara City Hospital Bilkent
- Study Director: Gonca Bumin, Prof, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E1-20-1038
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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