Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT00919906
Status:
COMPLETED
Last Update Posted:
2010-10-28
First Post:
2009-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
My Scrivener® - Measuring Effectiveness and Dose Response in Children
Sponsor:
Obslap Research LLC
Organization:
Study Overview
Official Title:
My Scrivener® - Measuring Effectiveness and Dose Response in Children
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.
Detailed Description:
This study builds on a large body of neurological research that uses robot-guided repetitive motion training to induce neuroplasticity and improvements in upper extremity motor skills in adults and children. This research study is looking at handwriting, a fine-motor task that is used daily.
In our study, we want to see if 3-dimensional robotic-assisted repetitive motion training can be a safe and effective intervention for school-age children with fine motor deficits arising from several different impairment origins. Our research construct is: Legible handwriting = function of (tactile feedback, visual feedback, duration, and fine-motor control).
Independent variables:
* Tactile feedback is a continuous variable of force-feedback measured in pounds of force.
* Duration is a continuous variable measured in seconds and number of repetitions.
* Visual feedback is the letter scribed on the paper.
Dependent variable:
* Legible handwriting will be measured by scoring on the Test of Handwriting Skills and the Print Tool™ evaluation.
* Fine motor deficit/control will be measured directly and objectively by quantifying the error between the desired scribing task and the actual scribing task.
The robotic device is an affordable (\<$200) computer haptic (the Falcon(R)) that currently is approved by the FCC for home and office. It is \*not\* approved for medical use. This is an investigational, nonsignificant risk device.
In our study, we want to see if 3-dimensional robotic-assisted repetitive motion training can be a safe and effective intervention for school-age children with fine motor deficits arising from several different impairment origins. Our research construct is: Legible handwriting = function of (tactile feedback, visual feedback, duration, and fine-motor control).
Independent variables:
* Tactile feedback is a continuous variable of force-feedback measured in pounds of force.
* Duration is a continuous variable measured in seconds and number of repetitions.
* Visual feedback is the letter scribed on the paper.
Dependent variable:
* Legible handwriting will be measured by scoring on the Test of Handwriting Skills and the Print Tool™ evaluation.
* Fine motor deficit/control will be measured directly and objectively by quantifying the error between the desired scribing task and the actual scribing task.
The robotic device is an affordable (\<$200) computer haptic (the Falcon(R)) that currently is approved by the FCC for home and office. It is \*not\* approved for medical use. This is an investigational, nonsignificant risk device.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| #H133S070082 | None | None | View |