NCT01378455

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 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

March 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 5, 2016

Status Verified

May 1, 2011

Enrollment Period

2 years

First QC Date

June 21, 2011

Last Update Submit

October 3, 2016

Conditions

Keywords

handwritingcerebral palsyvisual perceptionsensory functionmotor functioncomputerized handwriting programs

Outcome Measures

Primary Outcomes (1)

  • Body function and structure

    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 Outcomes (3)

  • Activities and participation

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

  • Quality of life

    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

Study Arms (2)

ICHTP group

EXPERIMENTAL

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

Other: interactive computerized handwriting training program

THTP group

ACTIVE COMPARATOR

The THTP (traditional handwriting training program)group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills

Other: traditional handwriting training program

Interventions

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.

Also known as: computerized handwriting training program
ICHTP group

The THTP group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills

THTP group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Chia-Ling Chen, MD,PhD

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 22, 2011

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

February 1, 2015

Last Updated

October 5, 2016

Record last verified: 2011-05

Locations