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PI decided to end the study
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This study is designed to pilot an intervention technique to reduce the self-stimulating behaviors seen in individuals with autism spectrum disorders using intervention with ProFoveate pellets. Self-stimulating behaviors like hand flapping, eye blinking, and rocking, can interfere with the individual's ability to interact with their peers. Participants will wear the pellets for four week and measures with taken again. Another group of participants will not get the pellets. Both groups will be tested at the beginning and end of the study. Any variations in self-stimulating behaviors will be documented through parent report, Observational data. The investigators hypothesize that they will see changes in self- stimulating behaviors as a result of the strategic placement of the ProFoveate™ pellets on the ears of one group of the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Profoveate | Experimental | 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. |
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| NonProFoveate | No Intervention | Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProFoveate | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of Self-stimulating Behaviors | Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment. | Baseline to 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Atcherson | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas at Little Rock Speech and Hearing Clinic | Little Rock | Arkansas | 72204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Profoveate | The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Profoveate | The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numbers of Self-stimulating Behaviors | Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment. | Students were given a Social Skills Improvement System (SSiS). Only 4 participants completed enrollment. Only 3 participants completed study. Study was terminated due to low enrollment. | Posted | Mean | Standard Deviation | behaviors | Baseline to 4 Weeks |
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adverse event data was collected for 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Profoveate | The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Betholyn Gentry | University of Arkansas for Medical Sciences | (501) 603-1010 | bfgenry@uams.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 8, 2014 | May 6, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
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