My Scrivener® - Measuring Effectiveness and Dose Response in Children

Completed

Phase 1/2 Results N/A

Trial Description

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 Toolâ„¢ 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.

Conditions

Interventions

  • My Scrivener(R) Device
    Other Names: My Scrivener; Falcon, by Novint Technologies; Handwriting Without Tears
    Intervention Desc: Twenty 20-minute sessions of the Handwriting Without Tears(R) instructional handwriting program, with substitution of hand-over-hand or self-generated repetitive motion writing by computer guided repetitive motion.
    ARM 1: Kind: Experimental
    Label: Haptic guidance

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Beery Motor Coordination Subtest after 20 interventions No
Primary Print Tool and Cursive Tool after 20 interventions No
Primary Deviations from desired 3-D writing path after 5, 10, 15, 20 interventions No
Secondary Brief Assessment of Fine Motor Skills after 20 interventions No

Sponsors