Healthy ChildrenNCT00693303
Examining the Effectiveness of My Scrivener on Handwriting Legibility
A study testing Handwriting Training using My Scrivener in people with Healthy Children, run by Shenandoah University at 1 site in United States.
Trial summary
The purpose of this study was to examine the changes in handwriting performance in elementary aged children who received handwriting training which included use of the My Scrivener stylus. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- Handwriting Training using My Scrivener
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The subjects were any child enrolled in the summer program at the Boys and Girls Club of the Northern Shenandoah Valley entering grades 1 to 6 in Fall 2008 whose parents give consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Boys and Girls Club of the Northern Shenandoah Valley
Winchester, Virginia, 22601
About this study
The purpose of this study was to examine the changes in handwriting performance in elementary aged children who received handwriting training which included use of the My Scrivener stylus. Training on the My Scrivener stylus provided additional feedback to the children which is hypothesized to produce significant improvement.
Read the detailed description
Once parental consent was given, students met individually with the PI or a trained occupational therapy graduate student in a private space at the Boys and Girls Club of the Northern Shenandoah Valley for a pre-test evaluation session. The evaluation consisted of the following:
- Evaluation Tool of Children's Handwriting (ETCH; Amundson, 1995). This is a criterion-referenced tool measuring a child's legibility and speed in grades one through six. This measure is able to evaluate both manuscript and cursive handwriting; however, only the manuscript portion will be used as that will be the focus of the club's training. The ETCH asks the child to write letters and words in lower-case and upper-case, write numerals, perform near point and far point copying, write to dictation, and compose original sentences. Total time for the evaluation is 15-20 minutes.
- Brief Assessment of Motor Function (BAMF: Parks, Cintas, Chaffin, \& Gerber, 2007). This is a criterion referenced tool that can identify gross, fine, and oral motor performance in as little as 10 minutes. For this particular study, only the Fine Motor Scale of the BAMF will be used. Data from this tool will be used to categorize subjects for between group comparisons.
- The Developmental Test of Visual Motor Integration (VMI: Beery, 1998). This gold-standard tool measures a child's visual motor performance by asking them to copy geometric shapes ranging from the very simple to the very complex. Data from this tool will be used to categorize subjects for between group comparisons.
Once all children were evaluated, twice weekly Handwriting Camp sessions were held. During these small group sessions lasting approximately 30 minutes each, 4 children at a time received instruction from the Handwriting Without Tears Curriculum from either the PI or trained OT graduate students and 20 minutes of supervised practice time on the My Scrivener equipment to reinforce the letter writing instruction for that day.
The Handwriting Camp sessions lasted for approximately 8 weeks.
At the conclusion of the camp, the pre-tests were re-administered as well as an open-ended question interview was conducted on how well the child enjoyed using the device.
- Conditions
- Healthy Children
- Being tested
- Handwriting Training using My Scrivener
- Keywords
- single subject, quantitative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handwriting Training using My ScrivenerBehavioural
Subjects received 20 minutes of training per week which included writing letters and words with the My Scivener device.
| Study group | Role | What they receive |
|---|---|---|
| Handwriting Training using My Scrivener | Experimental | Subjects received 20 minutes of training per week which included writing letters and words with the My Scivener device. Receives: Behavioral: Handwriting Training using My Scrivener |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation Tool of Children's Handwriting
This criterion-referenced tool measures a child's legibility and speed in grades one through six. The child writes letters and words, numerals, performs near point and far point copying, writes to dictation, and composes a sentence.
Measured: 8 weeks from start of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenandoah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Marr, Shenandoah University
- Investigators
- Deborah Marr, ScD, Principal investigator, Shenandoah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693303
- Sponsor's protocol ID
- 08-1125
- Other IDs
- #H133S070082
- Status last verified
- Jun 2017
- First submitted
- 5 Jun 2008
- Last updated
- 15 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of My Scrivener on Handwriting Legibility
- ClinicalTrials.gov ID
- NCT00693303
- Acronym / sponsor ID
- 08-1125
- Conditions
- Healthy Children
- Keywords
- single subject, quantitative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Shenandoah UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Posted 25 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to examine the changes in handwriting performance in elementary aged children who received handwriting training which included use of the My Scrivener stylus. Training on the My Scrivener stylus provided additional feedback to the children which is hypothesized to produce significant improvement.
Detailed description
Once parental consent was given, students met individually with the PI or a trained occupational therapy graduate student in a private space at the Boys and Girls Club of the Northern Shenandoah Valley for a pre-test evaluation session. The evaluation consisted of the following:
- Evaluation Tool of Children's Handwriting (ETCH; Amundson, 1995). This is a criterion-referenced tool measuring a child's legibility and speed in grades one through six. This measure is able to evaluate both manuscript and cursive handwriting; however, only the manuscript portion will be used as that will be the focus of the club's training. The ETCH asks the child to write letters and words in lower-case and upper-case, write numerals, perform near point and far point copying, write to dictation, and compose original sentences. Total time for the evaluation is 15-20 minutes.
- Brief Assessment of Motor Function (BAMF: Parks, Cintas, Chaffin, \& Gerber, 2007). This is a criterion referenced tool that can identify gross, fine, and oral motor performance in as little as 10 minutes. For this particular study, only the Fine Motor Scale of the BAMF will be used. Data from this tool will be used to categorize subjects for between group comparisons.
- The Developmental Test of Visual Motor Integration (VMI: Beery, 1998). This gold-standard tool measures a child's visual motor performance by asking them to copy geometric shapes ranging from the very simple to the very complex. Data from this tool will be used to categorize subjects for between group comparisons.
Once all children were evaluated, twice weekly Handwriting Camp sessions were held. During these small group sessions lasting approximately 30 minutes each, 4 children at a time received instruction from the Handwriting Without Tears Curriculum from either the PI or trained OT graduate students and 20 minutes of supervised practice time on the My Scrivener equipment to reinforce the letter writing instruction for that day.
The Handwriting Camp sessions lasted for approximately 8 weeks.
At the conclusion of the camp, the pre-tests were re-administered as well as an open-ended question interview was conducted on how well the child enjoyed using the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Handwriting Training using My Scrivener | Experimental | Behavioral: Handwriting Training using My ScrivenerSubjects received 20 minutes of training per week which included writing letters and words with the My Scivener device. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The subjects were any child enrolled in the summer program at the Boys and Girls Club of the Northern Shenandoah Valley entering grades 1 to 6 in Fall 2008 whose parents give consent.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Handwriting Training using My ScrivenerSubjects received 20 minutes of training per week which included writing letters and words with the My Scivener device. | Behavioural | Handwriting Training using My Scrivener |
Primary outcome
Evaluation Tool of Children's Handwriting
Time frame: 8 weeks from start of training
This criterion-referenced tool measures a child's legibility and speed in grades one through six. The child writes letters and words, numerals, performs near point and far point copying, writes to dictation, and composes a sentence.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Deborah Marr, ScD principal investigator
Shenandoah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handwriting Training using My Scrivener in people with Healthy Children, run by Shenandoah University at 1 site in United States.
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 1 inclusion and 1 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 15 Dec 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation Tool of Children's Handwriting (time frame: 8 weeks from start of training). 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 15 Dec 2017.