Examining the Effectiveness of My Scrivener on Handwriting Legibility

• Sponsor: Shenandoah University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00693303
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief 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. Training on the My Scrivener stylus provided additional feedback to the children which is hypothesized to produce significant improvement.

Condition or Disease	Intervention/Treatment	Phase
Healthy Children	Behavioral: Handwriting Training using My Scrivener	N/A

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:

1. 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.

2. 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.

3. 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

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Examining the Effectiveness of My Scrivener on Handwriting Legibility
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Handwriting Training using My Scrivener Subjects received 20 minutes of training per week which included writing letters and words with the My Scivener device.	Behavioral: Handwriting Training using My Scrivener; Subjects received 20 minutes of training per week which included writing letters and words with the My Scivener device.

Outcome Measures

Primary Outcome Measures

1. Evaluation Tool of Children's Handwriting [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boys and Girls Club of the Northern Shenandoah Valley	Winchester	Virginia	United States	22601

Sponsors and Collaborators

• Shenandoah University

Investigators

• Principal Investigator: Deborah Marr, ScD, Shenandoah University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deborah Marr, Assistant Professor, Shenandoah University
• ClinicalTrials.gov Identifier: NCT00693303
• Other Study ID Numbers: 08-1125; #H133S070082
• First Posted: Jun 9, 2008
• Last Update Posted: Dec 15, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Deborah Marr, Assistant Professor, Shenandoah University: single subject; quantitative

Study Results

Participant Flow

Arm/Group Title	My Scrivener Training
Arm/Group Description	Subjects practiced writing letters and words for 20 minutes two times per week using the My Scrivenor device.
Period Title: Overall Study
STARTED	21
COMPLETED	21
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	My Scrivener Training
Arm/Group Description	Children received My Scrivenor training
Overall Participants	21
Age (Count of Participants)
<=18 years	21 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9 (1.5)
Sex: Female, Male (Count of Participants)
Female	12 57.1%
Male	9 42.9%
Region of Enrollment (participants) [Number]
United States	21 100%
Evaluation Tool of Children's Handwriting (Mean percent of legible letters, & words) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Mean percent of legible letters, & words]	95 (9.9)

Outcome Measures

1. Primary Outcome

Title	Evaluation Tool of Children's Handwriting
Description	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.
Time Frame	8 weeks from start of training

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	My Scrivener Training
Arm/Group Description	Children received My Scrivenor training
Measure Participants	21
Mean (Standard Deviation) [percent of legible letters]	96 (6.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	My Scrivener Training
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.27
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	My Scrivener Training
Arm/Group Description	Children received My Scrivenor training
All Cause Mortality
	My Scrivener Training
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	My Scrivener Training
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Other (Not Including Serious) Adverse Events
	My Scrivener Training
	Affected / at Risk (%)	# Events
Total	0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.