NCT05169294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

2.3 years

First QC Date

December 13, 2021

Last Update Submit

July 24, 2024

Conditions

Keywords

cerebral palsyhandwritingoccupational therapy

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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).

    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.

    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.

    8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Telerehabilitation ProgramOther: Written Home Program

Control

ACTIVE COMPARATOR
Other: Written Home Program

Interventions

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

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.

ControlIntervention

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06430, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

December 13, 2021

First Posted

December 23, 2021

Study Start

November 1, 2020

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

July 26, 2024

Record last verified: 2024-07

Locations