Back to resultsThe Effect of Fine Motor Skills Training Through Telerehabilitation in Children With Diplegic Cerebral Palsy
Primary Purpose
Diplegia, Spastic
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation Program
Written Home Program
Sponsored by
About this trial
This is an interventional other trial for Diplegia, Spastic focused on measuring cerebral palsy, handwriting, occupational therapy
Eligibility Criteria
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.
Sites / Locations
- Hacettepe UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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, & Yıldız, 2018).
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05169294
Brief Title
The Effect of Fine Motor Skills Training Through Telerehabilitation in Children With Diplegic Cerebral Palsy
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ekin Akpınar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diplegia, Spastic
Keywords
cerebral palsy, handwriting, occupational therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Telerehabilitation Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Written Home Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Children's Hand Skills (ACHS)
Description
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.
Time Frame
8 weeks
Title
Minnesota Handwriting Assessment
Description
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.
Time Frame
8 weeks
Title
Shriners Hospital Upper Extremity Evaluation (SHUEE)
Description
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).
Time Frame
8 weeks
Title
Bruininks-Oseretsky Test of Motor Proficency 2- Short Form (BOT-2 SF)
Description
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.
Time Frame
8 weeks
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ekin Akpınar, BSc
Phone
0905436176551
Email
ekinakpinar@hacettepe.edu.tr
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06430
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekin Akpınar, BSc
Phone
0905436176551
Email
ekinakpinar@hacettepe.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Fine Motor Skills Training Through Telerehabilitation in Children With Diplegic Cerebral Palsy
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