Cerebral PalsyNCT01378455
Effectiveness of Handwriting Training Program on Handwriting Performance in Cerebral Palsy
A study testing interactive computerized handwriting training program and traditional handwriting training program in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- interactive computerized handwriting training program and traditional handwriting training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2010to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- interactive computerized handwriting training program, traditional handwriting training program
- Keywords
- handwriting, cerebral palsy, visual perception, sensory function, motor function, computerized handwriting programs
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive computerized handwriting training programOther
Also called 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.
traditional handwriting training programOther
The THTP group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: traditional handwriting training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Activities and participation: SFA,CAPE, PAC, etc.
Measured: pre-treatment, post-treatment, 3 months, 6 months, 12 months
Quality of life
pre-treatment, post-treatment, 3 months, 6 months, 12 months HRQOL: CPQOL, etc.
Measured: 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
Computer Analysis for Chinese Handwriting(CACH)
Measured: pre-treatment, post-treatment, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD,PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378455
- Sponsor's protocol ID
- 98-3193B
- Status last verified
- May 2011
- First submitted
- 21 Jun 2011
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interactive Computerized Handwriting Training Program on Handwriting Performance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01378455
- Acronym / sponsor ID
- 98-3193B
- Conditions
- Cerebral Palsy
- Keywords
- handwriting, cerebral palsy, visual perception, sensory function, motor function, computerized handwriting programs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICHTP group | Experimental | Other: interactive computerized handwriting training programIn 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 |
| THTP group | Active comparator | Other: traditional handwriting training programThe THTP (traditional handwriting training program)group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interactive computerized handwriting training programAlso: computerized handwriting training programIn 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 | ICHTP group |
| traditional handwriting training programThe THTP group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills | Other | THTP group |
Primary outcome
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.
3 secondary outcomes
Activities and participation
Time frame: 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
Computer Analysis for Chinese Handwriting(CACH)
Time frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, MD,PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interactive computerized handwriting training program and traditional handwriting training program in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body function and structure (time frame: pre-treatment, post-treatment, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.