Effectiveness of Handwriting Training Program on Handwriting Performance in Cerebral Palsy

October 3, 2016 updated by: Chang Gung Memorial Hospital

Effectiveness of Interactive Computerized Handwriting Training Program on Handwriting Performance in Children With Cerebral Palsy

Visual perception impairment and upper limb disability will affect the handwriting performance. Children with cerebral palsy (CP) who have good function on upper extremity may associated with visual perception impairment, which will impact the handwriting performance. However, there were few studies to investigate the handwriting problems in children with CP who have good upper limb functions. To date, there are no studies to investigate the effectiveness of computerized handwriting training programs on handwriting performance in children with CP. The aims of this study were to establish the relationships of visual perception, visual motor integration, and motor coordination of handwriting performance in children with typical development (TD) in Taiwan, to establish the norms of handwriting performance in children with TD in Taiwan, to compare handwriting performance in children with CP and children with TD, to clarify the relationship of visual perception function and handwriting performance in children with CP, and to examine the effectiveness of interactive computerized handwriting training program (ICHTP) on handwriting performance in children with CP.

The investigators will collect 90 children with TD and 48 children with CP in the 1st phase. All children will receive clinical and Chinese handwriting assessment tool (CHAT) assessments. The CHAT and ICHTP will be modified as Taiwan-version handwriting assessment tool and training programs for children in Taiwan, respectively. Clinical assessments include the visual perception, visual motor integration, fine motor skill, and handwriting performance. The CHAT assessed the handwriting legibility, accuracy, pen pressure and writing speed. In the 2nd phase, the investigators will collect 48 children with CP, who were randomly classified into ICHTP group and Traditional Handwriting Training Program (THTP). All children with CP will receive clinical and CHAT assessments before and after interventions.

The expected results of this study are the visual perception function is related to handwriting performance in children with CP, and the improvements in the handwriting legibility, accuracy, pen pressure and writing speed of ICHTP training group are greater than THTP training group.

Study Overview

Detailed Description

This study were to establish the relationships of visual perception, visual motor integration, and motor coordination of handwriting performance in children with TD in Taiwan, to establish the norms of handwriting performance in children with TD in Taiwan, to compare handwriting performance in children with CP and children with TD, to clarify the relationship of visual perception function and handwriting performance in children with CP in the first phase, and to examine the effectiveness of interactive computerized handwriting training program (ICHTP) via a randomized controlled study in children with CP in the second phase.The subjects are ninety children with typical development aged between 6-12 years from elementary school and forty-eight children with CP aged between 6-12 years from Chang Gung Memorial Hospital (Taipei branch, Linkou branch, Taoyuan branch, Kaohsiung branch), Far Eastern Memorial Hospital, Taipei Veterans General Hospital and Buddhist Tzu Chi General Hospital (Taipei branch)etc.Experimental design In first phase, we establish the relationships of visual perception, visual motor integration, and motor coordination of handwriting performance in children with TD in Taiwan, to establish the norms of handwriting performance in children with TD among different age groups in Taiwan, a comparison designed study to compare the handwriting performance among 2 CP groups and TD groups. All children were assigned into diplegia group, hemiplegia group, and typical development (TD) group. Then we will assessment the fine motor skill, visual perception and handwriting performance by occupational therapist.

Experimental procedures:

All children were assessed with clinical assessments and the Chinese handwriting assessment tool (CHAT). Clinical assessments included Manual Ability Classification System (MACS), Bruininks-Oseretsky Test of Motor Proficiency-second edition (BOT-II), the Test of Visual-Perceptual Skills Revised (TVPS-R), Beery-Buktenica Developmental Test of Visual-Motor Integration (Berry VMI) and comprehensive test of basic reading and writing. Evaluations were performed in about 1.5-2 hours in a silent and restful room, eliminating factors such as fatigue and distraction of attention and concentration, which could have an impact on the results. All the tests used in the study were individually administered to all children. The performance of all children was videotaped for later scoring.

In second phase, all CP children were randomized assigned into ICHTP group or THTP group. All participations will received clinical and CHAT assessments before and after intervention. Clinical assessments included Manual Ability Classification System (MACS), Bruininks-Oseretsky Test of Motor Proficiency-second edition (BOT-II), the Test of Visual-Perceptual Skills Revised (TVPS-R), Beery-Buktenica Developmental Test of Visual-Motor Integration (Berry VMI) and comprehensive test of basic reading and writing. Evaluations were performed in about 2 hours in a silent and restful room, eliminating factors such as fatigue and distraction of attention and concentration, which could have an impact on the results. All the tests used in the study were individually administered to all children. The performance of all children was videotaped for later scoring. The intervention consisted of ICHTP and THTP training programs, which is 45 min/once, three times/one week, and sustain four weeks.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taoyuan, Taiwan, 333
        • Chang Gung memorial hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ability to follow instructions and complete the assessment
  • agreement to join this study.
  • CP with hemiplegia and diplegia
  • Manual Ability Classification System (MACS) of dominant hand: levels 1-2

Exclusion Criteria:

  • psychosocial, behavioral and emotional problems, such as ADHD, and autism.
  • physical dysfunction, such as neuromuscular disorders.
  • significant hearing or visual impairment
  • significant sensory impairment.
  • Learning disability
  • Test of Nonverbal Intelligence( TONI-2) less than two standard deviation,
  • unstable medical situation (ex: seizure).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICHTP group
In ICHTP (interactive computerized handwriting training program) group, they received the training of visual-perception .visual-motor integration skill of children and modulate muscle strength of grasp through ICHTP software
In ICHTP group, they received the training of visual-perception .visual-motor integration skill of children and modulate muscle strength of grasp through ICHTP software. The training program costs 45 min/once, three times/one week, and sustains four weeks.In traditional group, they received the training of paper-pencil activities with visual-perception and visual-motor integration skills. The training duration is as long as ICHTP group.
Other Names:
  • computerized handwriting training program
Active Comparator: THTP group
The THTP (traditional handwriting training program)group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills
The THTP group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body function and structure
Time Frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months
pre-treatment, post-treatment, 3 months, 6 months, 12 months Body function and structure: TVPS, Reading and handwriting tests, SP, etc.
pre-treatment, post-treatment, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities and participation
Time Frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months

pre-treatment, post-treatment, 3 months, 6 months, 12 months

Activities and participation: SFA,CAPE, PAC, etc.

pre-treatment, post-treatment, 3 months, 6 months, 12 months
Quality of life
Time Frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months
pre-treatment, post-treatment, 3 months, 6 months, 12 months HRQOL: CPQOL, etc.
pre-treatment, post-treatment, 3 months, 6 months, 12 months
Computer Analysis for Chinese Handwriting(CACH)
Time Frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months

pre-treatment, post-treatment, 3 months, 6 months, 12 months

Computer Analysis for Chinese Handwriting(CACH)

pre-treatment, post-treatment, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Chia-Ling Chen, MD,PhD, Chang Gung memorial hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 22, 2011

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

May 1, 2011

More Information

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.

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