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

Diplegia, Spastic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169294
• Other study ID #: KA20090
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: September 2022

Study information

• Verified date: December 2021
• Source: Hacettepe University
• Contact: Ekin Akpinar, BSc
• Phone: 0905436176551
• Email: ekinakpinar[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Diplegia, Spastic

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.
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ekin Akpinar

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Children's Hand Skills (ACHS)	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.	8 weeks
Primary	Minnesota Handwriting Assessment	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.	8 weeks
Primary	Shriners Hospital Upper Extremity Evaluation (SHUEE)	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, & Yildiz, 2018).	8 weeks
Primary	Bruininks-Oseretsky Test of Motor Proficency 2- Short Form (BOT-2 SF)	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.	8 weeks
Primary	Canadian Occupational Performance Measure	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.	8 weeks