The Effect of Fine Motor Skills Training Through Telerehabilitation in Children With Diplegic Cerebral Palsy

Sponsor
Ekin Akpınar (Other)
Overall Status
Recruiting
CT.gov ID
NCT05169294
Collaborator
(none)
60
1
2
22
2.7

Study Details

Study Description

Brief Summary

The aim of this study is to compare the effect of occupational therapy intervention through two-way video call, versus occupational therapy home program in written form; on handwriting skills, occupational performance, fine motor and hand skills in children with diplegic cerebral palsy.

Condition or Disease Intervention/Treatment Phase
  • Other: Telerehabilitation Program
  • Other: Written Home Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Children to be included in the study will be divided into intervention (n: 30) and control (n: 30) groups by randomization. Block randomization will be done using randomizer.org. Children in both groups will be given an occupational therapy home program for intervention goals. Children in the intervention group will be given telerehabilitation and fine motor skills training for a total of 8 weeks, 45 minutes a day, 3 days a week.Children to be included in the study will be divided into intervention (n: 30) and control (n: 30) groups by randomization. Block randomization will be done using randomizer.org. Children in both groups will be given an occupational therapy home program for intervention goals. Children in the intervention group will be given telerehabilitation and fine motor skills training for a total of 8 weeks, 45 minutes a day, 3 days a week.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of Fine Motor Skills Training Through Telerehabilitation on Handwriting, Occupational Performance, Fine Motor Skills and Hand Skills in Children With Diplegic Cerebral Palsy
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Other: Telerehabilitation Program
Telerehabilitation program: Intervention will be applied by video interview for eight weeks, 3 days a week, 45 minutes a day through the Zoom application. The application is free and can be installed on desktop or laptop computers, tablets and smartphones. The content of the activities to be done for that session by phone call to the parent before the interventions; Information will be given about the preparations such as keeping the materials on the table, suitable environment for that week's session and camera angle. Instructions and tips for parent support during the intervention will be given before and during the session. Intervention will be focused on fine motor skills, handwriting skills and activities of daily life of the individuals.

Other: Written Home Program
Home program: After the evaluations, the activities towards the determined goals will be communicated to the parents as a home program in written and electronic format. Instructions and key points for the correct implementation of the activities will be presented to the parent, both in writing and verbally; The parent will be able to send questions and receive feedback to the therapists over the phone at any stage of the eight-week home program intervention process. No intervention will be applied to the child through direct video calls.

Active Comparator: Control

Other: Written Home Program
Home program: After the evaluations, the activities towards the determined goals will be communicated to the parents as a home program in written and electronic format. Instructions and key points for the correct implementation of the activities will be presented to the parent, both in writing and verbally; The parent will be able to send questions and receive feedback to the therapists over the phone at any stage of the eight-week home program intervention process. No intervention will be applied to the child through direct video calls.

Outcome Measures

Primary Outcome Measures

  1. Assessment of Children's Hand Skills (ACHS) [8 weeks]

    ACHS is an observational assessment that measures the effectiveness of manual dexterity in children aged 2-12 years when participating in meaningful activities. Scoring items are categorized as: manual gestures, body-related dexterity, arm-hand use, adaptive dexterity hand use, general quality, and bimanual skills. A six-level Likert scale is used to score all skill items (Chien, Brown, & McDonald, 2010; Chien et al, 2011; Chien & Brown, 2012). The application of this test takes about 10 minutes.

  2. Minnesota Handwriting Assessment [8 weeks]

    The Minnesota Handwriting Assessment is a writing quality assessment that includes copying seven words containing all the letters of the alphabet (Guzman Pasculli, Hiraga, & Pellegrini, 2017). Evaluation scores six components of the text: speed, legibility, form, alignment, size and spacing (Alhussaini. Meram & Buragada, 2016). The Turkish adaptation, validity and reliability of the Minnesota Handwriting Assessment was performed by Kavak and Bumin (Kavak & Bumin, 2006). This assessment takes less than 5 minutes to apply.

  3. Shriners Hospital Upper Extremity Evaluation (SHUEE) [8 weeks]

    SHUEE is an assessment developed to measure upper extremity function in children with hemiplegic cerebral palsy. SHUEE is a video-based assessment administered by an occupational therapist using standardized objects and tasks. The evaluation takes about 15 minutes and is then scored by the occupational therapist (Davids, Piece, Wagner et al, 2006). Turkish validity and reliability of SHUEE was done by Bumin et al. (Bumin, Özsezen, & Yıldız, 2018).

  4. Bruininks-Oseretsky Test of Motor Proficency 2- Short Form (BOT-2 SF) [8 weeks]

    BOT-2 is a tool that is frequently used in the evaluation of psychomotor characteristics in individuals aged 4-21 years (Jirovec, Musalek, & Mess, 2019). It is available in two versions, full form and short form. Four areas of psychomotor characteristics can be measured with BOT-2: (1) fine manual control, (2) accuracy and integrity, (3) manual coordination, and (4) physical coordination (Jirovec et al, 2019). In our study: Item 2 of the bilateral coordination subtest, Item 3, 4, 5 and 8 of the visual motor control subtest Item 7 of the upper extremity speed and motion accuracy subtest, will be applied and scored. The application of these substances takes approximately 5 minutes. Since BOT-2 is a motor assessment test, there is no need for a Turkish validity and reliability study to be performed.

  5. Canadian Occupational Performance Measure [8 weeks]

    COPM is a client-centered assessment tool used in occupational therapy (Carswell, McColl, Baptiste et al, 2004; Harris & Eng, 2004; Parker & Sykes, 2006; Enemark Larsen, Jessen Winge, & Christensen, 2019) The COPM assessment helps individuals to identify, prioritize and evaluate their occupational performance difficulties (Law, Baptiste, Carswell et al, 2015; Enemark Larsen et al, 2019). The Turkish adaptation, validity and reliability of the COPM were made by Torpil et al. (Torpil, Ekici, & Bumin, 2017). This assessment will take approximately 20 minutes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Being diagnosed with diplegic cerebral palsy

  • Being between the ages of 7-12

  • Being able to read and write

  • To be at level I-III in the Manual Ability Classification System (MACS)

  • To have the necessary devices (phone, tablet or computer) for video calling

  • Not being able to come to the faculty to conduct the first evaluation face to face

  • Not receiving occupational therapy in any special education center

Exclusion Criteria:
  • Presence of another neurological and/or psychiatric disease

  • Not giving consent to the study Individuals included in the study will be randomly assigned to the intervention and control groups. It is planned to keep the number of individuals in the intervention and control groups equal.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Turkey 06430

Sponsors and Collaborators

  • Ekin Akpınar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ekin Akpınar, Occupational Therapist, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05169294
Other Study ID Numbers:
  • KA20090
First Posted:
Dec 23, 2021
Last Update Posted:
Dec 23, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ekin Akpınar, Occupational Therapist, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 23, 2021