NCT04697771

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

December 28, 2020

Last Update Submit

February 17, 2024

Conditions

Keywords

ADHDHandwritingOccupational TherapyTelerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Minnesota Handwriting Test

    It evaluates six categories, including legibility, form, alignment, size, spacing, and rate

    5 minute

Secondary Outcomes (1)

  • Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2)

    15 minute

Study Arms (2)

Intervention Group

EXPERIMENTAL

First Evaluation - Fine Motor Skills Training - 8 week - 3 session per week - 40 minute per session - Second Evaluation

Other: Fine Motor Skills Training

Control Group

NO INTERVENTION

First Evaluation - 8 week waiting period - Second Evaluation

Interventions

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.

Intervention Group

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with an additional physical and neurological problem to accompany

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Ankara - Altındağ, 06, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Gonca Bumin, Prof

    Hacettepe University

    STUDY DIRECTOR
  • Hakan Öğütlü, Msc

    Ankara City Hospital Bilkent

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person making the first and last outcome assessor does not know which group the participants are from.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist, MSc

Study Record Dates

First Submitted

December 28, 2020

First Posted

January 6, 2021

Study Start

December 1, 2020

Primary Completion

November 30, 2022

Study Completion

December 28, 2022

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations