Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Telerehabilitation on Handwriting Performance in Children With ADHD: RCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04697771
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Busra Kaplan, Hacettepe University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Handwriting Telerehabilitation Fine Motor Skills Other: Fine Motor Skills Training Not Applicable

Detailed Description:

It is planned that 40 children between the ages of 7-12 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.

The first and last data in the study group will be analyzed with the Wilcoxon Paired Test.Study and control group data will be compared by Mann-Whitney U or Independent T Test.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be randomly divided into two groups. The same intervention will be applied to the second group after the first group has received intervention for 8 weeks.
Masking: Single (Outcomes Assessor)
Masking Description: The person making the first and last outcome assessor does not know which group the participants are from.
Primary Purpose: Treatment
Official Title: The Effect of Telerahabilitation on Fine Motor Skills and Writing Performance in Children With Attention Deficit and Hyperactivity Disorder: A Randomized Controlled Study
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Study Group
First Evaluation - Fine Motor Skills Training - 8 week - 3 session per week - 40 minute per session - Second Evaluation
 Other: Fine Motor Skills Training
Fine Motor Skills Training The sessions will be held by considering the fine motor skills training and the criteria of fidelity of the fine motor interventions suggested by Pfeiffer et al. Each goal was enriched with activities and games that improve fine motor skills and handwriting performance.
Kontrol Group
First Evaluation - 8 week waiting period - Second Evaluation - 8 week Fine Motor Skills Training
 Other: Fine Motor Skills Training
Fine Motor Skills Training The sessions will be held by considering the fine motor skills training and the criteria of fidelity of the fine motor interventions suggested by Pfeiffer et al. Each goal was enriched with activities and games that improve fine motor skills and handwriting performance.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Minnesota Handwriting Test [ Time Frame: 5 minute ]
    It evaluates six categories, including legibility, shape, alignment, size, spacing, and handwriting speed


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To be in the age range of 7-12,
  • Diagnosed with Attention Deficit Hyperactivity Disorder,
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697771


Contacts
Layout table for location contacts
Contact: Büşra Kaplan, MSc +905543303227 ergoterapistki@gmail.com
Contact: Gonca Bumin, Prof +903123052560 gbumin@hacettepe.edu.tr

Locations
Layout table for location information
Turkey
Hacettepe University Recruiting
Ankara, Ankara - Altındağ, Turkey, 06
Contact: Gonca Bumin, Prof    +03123052560    gbumin@hacettepe.edu.tr   
Sponsors and Collaborators
Hacettepe University
Investigators
Layout table for investigator information
Study Director: Gonca Bumin, Prof Hacettepe University
Study Director: Hakan Öğütlü, Msc Ankara City Hospital Bilkent
  Study Documents (Full-Text)

Documents provided by Busra Kaplan, Hacettepe University:
Study Protocol and Statistical Analysis Plan  [PDF] September 2, 2020
Informed Consent Form  [PDF] September 2, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Busra Kaplan, Occupational Therapist, MSc, Hacettepe University
ClinicalTrials.gov Identifier: NCT04697771    
Other Study ID Numbers: E1-20-1038
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Busra Kaplan, Hacettepe University:
ADHD
Handwriting
Occupational Therapy
Telerehabilitation