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Effectiveness of Handwriting Training Program on Handwriting Performance in Cerebral Palsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01378455
First received: June 21, 2011
Last updated: June 10, 2013
Last verified: May 2011

June 21, 2011
June 10, 2013
March 2010
March 2012   (final data collection date for primary outcome measure)
Body function and structure [ Time Frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
pre-treatment, post-treatment, 3 months, 6 months, 12 months Body function and structure: TVPS, Reading and handwriting tests, SP, etc.
visual perception [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01378455 on ClinicalTrials.gov Archive Site
  • Activities and participation [ Time Frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

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

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

  • Quality of life [ Time Frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    pre-treatment, post-treatment, 3 months, 6 months, 12 months HRQOL: CPQOL, etc.
  • Computer Analysis for Chinese Handwriting(CACH) [ Time Frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

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

    Computer Analysis for Chinese Handwriting(CACH)

handwriting performance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effectiveness of Handwriting Training Program on Handwriting Performance in Cerebral Palsy
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cerebral Palsy
  • Other: interactive computerized handwriting training program
    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 Name: computerized handwriting training program
  • Other: traditional handwriting training program
    The THTP group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills
    Other Name: traditional handwriting training program
  • 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
    Intervention: Other: interactive 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
    Intervention: Other: traditional handwriting training program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
186
July 2015
March 2012   (final data collection date for primary outcome measure)

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).
Both
6 Years to 12 Years
Yes
Contact: Chia-Ling Chen, MD,PHD +886-3-3281200 ext 8147 clingchen@gmail.com
Taiwan
 
NCT01378455
98-3193B
Yes
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Study Director: Chia-Ling Chen, MD,PhD Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP