- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05169294
The Effect of Fine Motor Skills Training Through Telerehabilitation in Children With Diplegic Cerebral Palsy
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06430
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
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.
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
|
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).
|
8 weeks
|
|
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:
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
|
|
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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA20090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diplegia, Spastic
-
Cairo UniversityUnknownSpastic Diplegia Cerebral PalsyEgypt
-
National Institute of Neurological Disorders and...Completed
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
Cairo UniversityNot yet recruiting
-
Amira saad mohamedActive, not recruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Columbia UniversityRecruitingCerebral Palsy | Spastic Diplegia | Spastic Hemiplegia | Spastic QuadriplegiaUnited States
-
Lamis Neyazy ElrakhawyCompletedSpastic Diplegia Cerebral PalsyEgypt
-
Wroclaw University of Health and Sport SciencesNot yet recruitingSpastic Diplegia Cerebral Palsy | Spastic HemiplegiaPoland
-
Cairo UniversityRecruitingCerebral Palsy (CP) | Spastic DiplegiaEgypt
Clinical Trials on Telerehabilitation Program
-
Inonu UniversityFirat UniversityRecruitingTelerehabilitation | Anklyosing SpondylitisTurkey (Türkiye)
-
Istituto Auxologico ItalianoPolitecnico di MilanoCompleted
-
Campus docent Sant Joan de Déu-Universitat de BarcelonaCompletedCOVID-19 Acute Respiratory Distress SyndromeSpain
-
Centre de Recherche de l'Institut Universitaire...Unknown
-
Saglik Bilimleri UniversitesiCompletedTelerehabilitation | Fibrosing Interstitial Lung DiseaseTurkey
-
Aysan YaghoubiCompletedRotator Cuff TearsTurkey (Türkiye)
-
Saglik Bilimleri UniversitesiCompleted
-
Cairo UniversityRecruiting
-
Istanbul Medipol University HospitalRecruiting
-
Adelaida María Castro-SánchezAndaluz Health ServiceActive, not recruiting