Diplegia, SpasticNCT05169294
The Effect of Fine Motor Skills Training Through Telerehabilitation in Children With Diplegic Cerebral Palsy
A study testing Telerehabilitation Program and Written Home Program in people with Diplegia, Spastic, run by Ekin Akpınar at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Diplegia, Spastic
- What is being tested?
- Telerehabilitation Program and Written Home Program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Diplegia, Spastic
- Being tested
- Telerehabilitation Program, Written Home Program
- Keywords
- cerebral palsy, handwriting, occupational therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation ProgramOther
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 ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Telerehabilitation Program; Other: Written Home Program |
| Control | Active comparator | Not described Receives: Other: Written Home Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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).
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Nov 2020
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegia, SpasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ekin Akpınar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ekin Akpınar, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169294
- Sponsor's protocol ID
- KA20090
- Status last verified
- Jul 2024
- First submitted
- 13 Dec 2021
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05169294
- Acronym / sponsor ID
- KA20090
- Conditions
- Diplegia, Spastic
- Keywords
- cerebral palsy, handwriting, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ekin AkpınarUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Telerehabilitation Program, Other: Written Home Program |
| Control | Active comparator | Other: Written Home Program |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation ProgramTelerehabilitation 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 | Intervention |
| Written Home ProgramHome 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. | Other | Control, Intervention |
Primary outcome
Assessment of Children's Hand Skills (ACHS)
Time frame: 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.
Minnesota Handwriting Assessment
Time frame: 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.
Shriners Hospital Upper Extremity Evaluation (SHUEE)
Time frame: 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).
Bruininks-Oseretsky Test of Motor Proficency 2- Short Form (BOT-2 SF)
Time frame: 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.
Canadian Occupational Performance Measure
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Program and Written Home Program in people with Diplegia, Spastic, run by Ekin Akpınar at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Children's Hand Skills (ACHS) (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.