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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00693303
Other study ID # 08-1125
Secondary ID #H133S070082
Status Completed
Phase N/A
First received June 5, 2008
Last updated June 20, 2017
Start date June 2008
Est. completion date August 2008

Study information

Verified date June 2017
Source Shenandoah University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 13 Years
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Boys and Girls Club of the Northern Shenandoah Valley Winchester Virginia

Sponsors (1)

Lead Sponsor Collaborator
Shenandoah University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 weeks from start of training
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