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To research the use of a novel set of intraoral tools called the Easy Stretch Toolkit for the therapeutic management of facial burns and other facial disorders.
In this initial pilot study, we plan to recruit 20 adult or pediatric patients who have sustained facial burns or who have sustained a facial injury resulting in scarring, tightness, limited range of motion of facial skin or musculature, or fibrosis to complete the 8 week treatment. Participants will need to be able to attend a weekly telehealth or in person session with the investigators and complete the entire 8 week prescriptive program. Participants will be outpatient. A facial injury can be any disorder that results in scarring, tightness, limited range of motion of facial skin or musculature or fibrosis. Facial burn injury or facial injury is defined as an injury to the midface or lower half of the face and may be unilateral or bilateral. Participants must be in the chronic phase of recovery. Chronic burns are defined as those burns that are not in the acute healing phase, ie., there are no concerns for injury to new or healing skin or wound dehiscence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Easy Stretch Toolkit | Experimental | All participants will be using one or more of devices for 60 minutes 2 times per day for the duration of the 8 week trial. Prescriptive instructions for specific intraoral placements will be given based on the participant's deficit areas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Easy Stretch Toolkit | Device | Study the use of novel intraoral tools for management of facial burns and other facial disorders |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Facial Range of Motion at Baseline and Week 8 | Facial measurements taken during select facial movements/expressions assessed by software program created at UTMB specifically for this project. The degree of change in facial movements will be assessed with 9 facial postures (face at rest, nose wrinkle, gentle smile, broad smile with lips closed, broad smile with teeth together, voice "eee", voice "ooo", pucker lips and open mouth wide), which will be photographed weekly. Two examples of the facial landmarks to be plotted and measured during each of the above expressions include right pupil to outside of right nare and length of philtrum, with the goal of measuring change over time with use of the Easy Stretch devices. Each of these measurements will produce a length in millimeters. Cumulative average of measurements will be reported per facial posture per participant. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Facial Disability Index Scores From Baseline to Week 8 | The Facial Disability Index (FDI) is a validated quality-of-life questionnaire consisting of 10 items, each scored on a 0-5 scale. Five items assess physical function and five items assess social well-being and function. Raw subscale scores are transformed according to standard FDI scoring procedures to yield physical function scores ranging from 0 to 100 and social function scores ranging from 0 to 100. The total Facial Disability Index score is calculated by summing the transformed physical and social subscale scores, resulting in a total score range of 0 to 200. Higher scores indicate better facial function and quality of life, while lower scores indicate greater facial disability. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Arguello | employee of University of Texas Medical Branch | Principal Investigator |
| Kathleen Kerr | employee of University of Texas Medical Branch | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26120089 | Background | Clayton NA, Ward EC, Maitz PK. Orofacial contracture management outcomes following partial thickness facial burns. Burns. 2015 Sep;41(6):1291-7. doi: 10.1016/j.burns.2015.02.015. Epub 2015 Jun 26. | |
| 27575671 | Background | Clayton NA, Ward EC, Maitz PK. Intensive swallowing and orofacial contracture rehabilitation after severe burn: A pilot study and literature review. Burns. 2017 Feb;43(1):e7-e17. doi: 10.1016/j.burns.2016.07.006. Epub 2016 Aug 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Easy Stretch Toolkit | All participants will be using one or more of devices for 60 minutes 2 times per day for the duration of the 8 week trial. Prescriptive instructions for specific intraoral placements will be given based on the participant's deficit areas. Easy Stretch Toolkit: Study the use of novel intraoral tools for management of facial burns and other facial disorders |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Easy Stretch Toolkit | All participants will be using one or more of devices for 60 minutes 2 times per day for the duration of the 8 week trial. Prescriptive instructions for specific intraoral placements will be given based on the participant's deficit areas. Easy Stretch Toolkit: Study the use of novel intraoral tools for management of facial burns and other facial disorders |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in the Facial Range of Motion at Baseline and Week 8 | Facial measurements taken during select facial movements/expressions assessed by software program created at UTMB specifically for this project. The degree of change in facial movements will be assessed with 9 facial postures (face at rest, nose wrinkle, gentle smile, broad smile with lips closed, broad smile with teeth together, voice "eee", voice "ooo", pucker lips and open mouth wide), which will be photographed weekly. Two examples of the facial landmarks to be plotted and measured during each of the above expressions include right pupil to outside of right nare and length of philtrum, with the goal of measuring change over time with use of the Easy Stretch devices. Each of these measurements will produce a length in millimeters. Cumulative average of measurements will be reported per facial posture per participant. | 8 enrolled, only 4 completed program | Posted | Median | Full Range | mm | 8 weeks |
|
8 weeks for each participant or the duration that they were enrolled in the study
reviewed with each participant at the start of each session to ensure no adverse events had occurred during the use of the tools
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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 | Easy Stretch Toolkit | All participants will be using one or more of devices for 60 minutes 2 times per day for the duration of the 8-week trial. Prescriptive instructions for specific intraoral placements will be given based on the participant's deficit areas. Easy Stretch Toolkit: Study the use of novel intraoral tools for management of facial burns and other facial disorders. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Kerr | University of Texas Medical Branch | 409-772-2711 | kmkerr@utmb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2020 | Dec 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005151 | Facial Injuries |
| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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| baseline and week 8 |
| 16413399 | Background | Macintyre L, Baird M. Pressure garments for use in the treatment of hypertrophic scars--a review of the problems associated with their use. Burns. 2006 Feb;32(1):10-5. doi: 10.1016/j.burns.2004.06.018. |
| 24799851 | Background | Atiyeh BS, El Khatib AM, Dibo SA. Pressure garment therapy (PGT) of burn scars: evidence-based efficacy. Ann Burns Fire Disasters. 2013 Dec 31;26(4):205-12. |
| 27359188 | Background | Clayton NA, Ellul G, Ward EC, Scott A, Maitz PK. Orofacial Contracture Management: Current Patterns of Clinical Practice in Australian and New Zealand Adult Burn Units. J Burn Care Res. 2017 Jan/Feb;38(1):e204-e211. doi: 10.1097/BCR.0000000000000351. |
| 23816994 | Background | Parry I, Sen S, Palmieri T, Greenhalgh D. Nonsurgical scar management of the face: does early versus late intervention affect outcome? J Burn Care Res. 2013 Sep-Oct;34(5):569-75. doi: 10.1097/BCR.0b013e318278906d. |
| 22508895 | Background | Hadlock TA, Urban LS. Toward a universal, automated facial measurement tool in facial reanimation. Arch Facial Plast Surg. 2012 Jul-Aug;14(4):277-82. doi: 10.1001/archfacial.2012.111. |
| 24314374 | Background | Marur T, Tuna Y, Demirci S. Facial anatomy. Clin Dermatol. 2014 Jan-Feb;32(1):14-23. doi: 10.1016/j.clindermatol.2013.05.022. |
| 22499369 | Background | Jorge JJ Jr, Pialarissi PR, Borges GC, Squella SA, de Gouveia Mde F, Saragiotto JC Jr, Goncalves VR. Objective computerized evaluation of normal patterns of facial muscles contraction. Braz J Otorhinolaryngol. 2012 Apr;78(2):41-51. doi: 10.1590/S1808-86942012000200008. |
| 29937780 | Background | Feng G, Zhuang Y, Gao Z. Measurement and analysis of associated mimic muscle movements. J Otol. 2015 Mar;10(1):39-45. doi: 10.1016/j.joto.2015.06.001. Epub 2015 Aug 1. |
| 10823477 | Background | Coulson SE, Croxson GR, Gilleard WL. Quantification of the three-dimensional displacement of normal facial movement. Ann Otol Rhinol Laryngol. 2000 May;109(5):478-83. doi: 10.1177/000348940010900507. |
| 8959998 | Background | VanSwearingen JM, Brach JS. The Facial Disability Index: reliability and validity of a disability assessment instrument for disorders of the facial neuromuscular system. Phys Ther. 1996 Dec;76(12):1288-98; discussion 1298-300. doi: 10.1093/ptj/76.12.1288. |
| 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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| Region of Enrollment | Number | participants |
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Facial measurement data were collected at week 1 and week 8 for each participant as distance between 2 facial landmarks as the participant completed requested facial expressions such as "open mouth wide" and "gentle smile". Data was collected for 13 measurements across 9 facial expressions. |
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| Secondary | Change in the Facial Disability Index Scores From Baseline to Week 8 | The Facial Disability Index (FDI) is a validated quality-of-life questionnaire consisting of 10 items, each scored on a 0-5 scale. Five items assess physical function and five items assess social well-being and function. Raw subscale scores are transformed according to standard FDI scoring procedures to yield physical function scores ranging from 0 to 100 and social function scores ranging from 0 to 100. The total Facial Disability Index score is calculated by summing the transformed physical and social subscale scores, resulting in a total score range of 0 to 200. Higher scores indicate better facial function and quality of life, while lower scores indicate greater facial disability. | Posted | Mean | Full Range | score on a scale | baseline and week 8 |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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