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Asperger's SyndromePhase 1/2NCT00919906

My Scrivener® - Measuring Effectiveness and Dose Response in Children

A Phase 1/2 study testing My Scrivener(R) in people with Asperger's Syndrome and Dyslexia, run by Obslap Research LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 19 years
Conditions the study is for
Asperger's Syndrome, Dyslexia, Cerebral Palsy
What is being tested?
My Scrivener(R)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteUnited States
Study dates
Apr 2009to Sep 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

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 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Meet the following base prerequisites for writing: orientation to written language; eye-hand coordination, single handed utensil or tool manipulation (BAMF score >= 6), recognize all letters of the alphabet (unless the child has dyslexia).
  • Children have illegible printing for their grade, or legible printing but a speed less than the norms for their grade and sex.
  • Be able to grasp a pen.
  • Be able to speak and understand English.
  • Be able to follow instructions.
  • Be able to devote at least 20 minutes to the assigned tasks (short breaks will be allowed).
  • Be enrolled in school at grade K or above.
  • A score lower than 80% on the Print Tool™ or the Cursive Tool.

Who cannot join

  • Unable to pass the informed assent screener.
  • Unwilling to sign or mark the informed assent documents.
  • Uncontrolled spasticity.
  • A BAMF score lower than 6 (includes severe paralysis of the upper extremity).
  • Cerebral palsy other than hemiplegia cerebral palsy
  • Severe autism or intellectual disabilities that prevent productive interactions with the investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Susan Palsbo

    Eugene, Oregon, 97405

Other trials in United States

About this study

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.

Read the 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.

Being tested
My Scrivener(R)
Keywords
haptic, rehabilitation, fine-motor skill, handwriting
Medical subject headings
Asperger Syndrome, Dyslexia, Cerebral Palsy, Attention Deficit Disorder with Hyperactivity, Brain Injuries, Traumatic, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • My Scrivener(R)Device

    Also called My Scrivener, Falcon, by Novint Technologies, Handwriting Without Tears

    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.

Study groups in NCT00919906
Study groupRoleWhat they receive
Handwriting without TearsNo interventionStandard practice
Haptic guidanceExperimentalNot described
Receives: Device: My Scrivener(R)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beery Motor Coordination Subtest

    Measured: after 20 interventions

  2. Print Tool and Cursive Tool

    Measured: after 20 interventions

  3. Deviations from desired 3-D writing path

    Measured: after 5, 10, 15, 20 interventions

Secondary outcomes (1)

  1. Brief Assessment of Fine Motor Skills

    Measured: after 20 interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00919906
Sponsor's protocol ID
002
Other IDs
#H133S070082
Status last verified
Oct 2010
First submitted
10 Jun 2009
Last updated
28 Oct 2010
Results posted
No
Data monitoring committee
No

Publications

  • Bluteau J, Coquillart S, Payan Y, Gentaz E. Haptic guidance improves the visuo-manual tracking of trajectories. PLoS One. 2008 Mar 12;3(3):e1775. doi: 10.1371/journal.pone.0001775.

    PubMed 18335049

  • O'Malley MK, Ro T, Levin HS. Assessing and inducing neuroplasticity with transcranial magnetic stimulation and robotics for motor function. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S59-66. doi: 10.1016/j.apmr.2006.08.332.

    PubMed 17140881

  • Volman MJ, van Schendel BM, Jongmans MJ. Handwriting difficulties in primary school children: a search for underlying mechanisms. Am J Occup Ther. 2006 Jul-Aug;60(4):451-60. doi: 10.5014/ajot.60.4.451.

    PubMed 16915876

  • Denton PL, Cope S, Moser C. The effects of sensorimotor-based intervention versus therapeutic practice on improving handwriting performance in 6- to 11-year-old children. Am J Occup Ther. 2006 Jan-Feb;60(1):16-27. doi: 10.5014/ajot.60.1.16.

    PubMed 16541981

  • Palluel-Germain R, Bara F, Hillairet de Boisferon A, Hennion B, Gouagout P, Gentaz E. 2007. A visuo-haptic device - Telemaque - increases kindergarten children's handwriting acquisition. In proceedings of IEEE World Haptics 2007, pp72-77.

  • Marr D, Dimeo SB. Outcomes associated with a summer handwriting course for elementary students. Am J Occup Ther. 2006 Jan-Feb;60(1):10-5. doi: 10.5014/ajot.60.1.10.

    PubMed 16541980

  • Palsbo SE, Hood-Szivek P. Effect of robotic-assisted three-dimensional repetitive motion to improve hand motor function and control in children with handwriting deficits: a nonrandomized phase 2 device trial. Am J Occup Ther. 2012 Nov-Dec;66(6):682-90. doi: 10.5014/ajot.2012.004556.

    PubMed 23106988

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing My Scrivener(R) in people with Asperger's Syndrome and Dyslexia, run by Obslap Research LLC 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 8 inclusion and 6 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 28 Oct 2010. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Beery Motor Coordination Subtest (time frame: after 20 interventions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00919906, which also lists 7 linked publications.

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 28 Oct 2010.

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