Effectiveness of Handwriting Training Program on Handwriting Performance in Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
interactive computerized handwriting training program
traditional handwriting training program
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring handwriting, cerebral palsy, visual perception, sensory function, motor function, computerized handwriting programs
Eligibility Criteria
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).
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ICHTP group
THTP group
Arm Description
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
The THTP (traditional handwriting training program)group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Activities and participation
pre-treatment, post-treatment, 3 months, 6 months, 12 months
Activities and participation: SFA,CAPE, PAC, etc.
Quality of life
pre-treatment, post-treatment, 3 months, 6 months, 12 months HRQOL: CPQOL, etc.
Computer Analysis for Chinese Handwriting(CACH)
pre-treatment, post-treatment, 3 months, 6 months, 12 months
Computer Analysis for Chinese Handwriting(CACH)
Full Information
NCT ID
NCT01378455
First Posted
June 21, 2011
Last Updated
October 3, 2016
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01378455
Brief Title
Effectiveness of Handwriting Training Program on Handwriting Performance in Cerebral Palsy
Official Title
Effectiveness of Interactive Computerized Handwriting Training Program on Handwriting Performance in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
handwriting, cerebral palsy, visual perception, sensory function, motor function, computerized handwriting programs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICHTP group
Arm Type
Experimental
Arm Description
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
Arm Title
THTP group
Arm Type
Active Comparator
Arm Description
The THTP (traditional handwriting training program)group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills
Intervention Type
Other
Intervention Name(s)
interactive computerized handwriting training program
Other Intervention Name(s)
computerized handwriting training program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional handwriting training program
Intervention Description
The THTP group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills
Primary Outcome Measure Information:
Title
Body function and structure
Description
pre-treatment, post-treatment, 3 months, 6 months, 12 months Body function and structure: TVPS, Reading and handwriting tests, SP, etc.
Time Frame
pre-treatment, post-treatment, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Activities and participation
Description
pre-treatment, post-treatment, 3 months, 6 months, 12 months
Activities and participation: SFA,CAPE, PAC, etc.
Time Frame
pre-treatment, post-treatment, 3 months, 6 months, 12 months
Title
Quality of life
Description
pre-treatment, post-treatment, 3 months, 6 months, 12 months HRQOL: CPQOL, etc.
Time Frame
pre-treatment, post-treatment, 3 months, 6 months, 12 months
Title
Computer Analysis for Chinese Handwriting(CACH)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Ling Chen, MD,PhD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
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Effectiveness of Handwriting Training Program on Handwriting Performance in Cerebral Palsy
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