The Effects of ProFoveate on Reducing Self-Stimulating Behaviors
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|ClinicalTrials.gov Identifier: NCT02088047|
Recruitment Status : Terminated (PI decided to end the study)
First Posted : March 14, 2014
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders Normal Hearing Normal Intelligence Exhibit Self- Stimulating or Ritualistic Behaviors||Device: ProFoveate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effects of ProFoveate on Reducing Self-Stimulating Behaviors in Children Diagnosed With Autism Spectrum Disorders|
|Actual Study Start Date :||August 30, 2014|
|Actual Primary Completion Date :||October 4, 2018|
|Actual Study Completion Date :||October 4, 2018|
The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment. Steel pellets (1.2 mm) will be placed strategically on ears following instructions on how to use the ProFoveate™ pellets. Parents will be provided with a Patient Diary Sheet and will be instructed to perform and document daily checks for placement of the pellets. Parents will be given a one month supply of stainless steel pellets at the initial study visit. Child participants will wear the stainless steel ProFoveate™ pellets for four weeks.
ProFoveate™ intervention for nystagmus is a management approach comprised of non-magnetic, 1.2 mm spheres that can be made from either stainless steel, gold plated stainless steel or titanium, placed strategically about the face and ears and a set of exercises designed to support improved vision for patients with nystagmus.The spheres (i.e., stimulating press balls or pellets) are supplied in packages of 20 with each sphere supplied on a transparent hypoallergenic adhesive tape approximately 7.6 mm in diameter. Within each package, all spheres are individually contained on a single paper backing measuring approximately 8.5 cm by 1.7 cm. Individual pellets (with adhesive tape) are removed from the backing as needed according to the prescribed treatment regimen.
No Intervention: NonProFoveate
Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.
- Numbers of Self-stimulating Behaviors [ Time Frame: Baseline to 4 Weeks ]Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088047
|United States, Arkansas|
|University of Arkansas at Little Rock Speech and Hearing Clinic|
|Little Rock, Arkansas, United States, 72204|
|Principal Investigator:||Samuel Atcherson||University of Arkansas|