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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG056255 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| University of Minnesota | OTHER |
| Georgia Institute of Technology | OTHER |
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Pressure-related injuries in individuals with SCI and persons who use wheelchairs are one of the most dangerous secondary health problems encountered throughout the lifespan. With recurrence rates as high as 79% and mortality rates as high as 48% when sepsis is present, there exists a critical clinical need to target prevention of pressure injuries.
This study will examine the effects of two novel seat mapping technologies ("AW-Shift" and "Sensoria") on increasing in-seat movement in persons who may be at risk for pressure injuries due to altered sensation on their sitting surface. AW-Shift provides a visual display about pressure distribution directly between the body and the seat cushion to a wheelchair user outside of a clinical setting. Sensoria represents a novel technology to promote tissue health by providing users with information about their daily in-seat movement and providing weight shift reminders that are based on time since previous weight shift activities. Changes in the frequency of in-seat movement behaviors will be compared between baseline and each intervention period.
For almost 50 years, clinicians and researchers have been interested in devices to monitor pressure and weight shift frequency, send alerts, provide cues, or track movement patterns in wheelchair users.
Despite the prevention efforts implemented over the years, pressure injuries continue to occur at a high rate of incidence. Without sensation to guide the need for changes in position to alleviate pressure, individuals with decreased sensation move significantly less than individuals with normal sensory systems. Thus, movement is a potentially robust protective factor to target. When focusing on movement as a modifiable risk factor, there is evidence that more in-seat movement is protective in wheelchair users. Behaviors, such as weight shifting to relieve pressure, decay over time, which could be attributed to lack of sensation to provide a natural cue to move. More work is needed to understand the types of movement that are most beneficial, and how to empower wheelchair users to move more often.
Our hypotheses are that A) Individuals will complete more frequent and more consistent weight shifts with access to the feedback systems compared to baseline and B) Self-efficacy beliefs for completing weight shifts will increase with use of the feedback systems.
This study will examine the effects of two novel seat mapping technologies ("AW-Shift" and "WiSAT") on increasing in-seat movement in persons who may be at risk for pressure injuries due to altered sensation on their sitting surface. AW-Shift provides a rich visual display about pressure distribution directly between the body and the seat cushion to a wheelchair user outside of a clinical setting. WiSAT represents a novel technology to promote tissue health by providing users with information about their daily in-seat movement and providing weight shift reminders that are based on time since previous weight shift activities. Changes in the frequency of in-seat movement behaviors will be compared between baseline and each intervention period.
The successful completion of this project will make large advancements in optimizing feedback about pressure and movement that will help wheelchair users become more effective in managing pressure distribution on an ongoing, daily basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensoria first intervention | Active Comparator | Group 1 participants will receive the Sensoria intervention during the first intervention phase for 4 weeks, and then the AW-Shift intervention during the second intervention phase for 4 weeks. |
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| AW-Shift first intervention | Active Comparator | Group 2 participants will receive the AW-Shift intervention during the first intervention phase for 4 weeks, and then the Sensoria intervention during the second intervention phase for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensoria | Behavioral | The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Normalized Weight Shift Frequency (Weight Shifts/Hour) | The normalized average weight shift frequency per hour of wheelchair occupancy for each intervention phase. For each day of the intervention phases, a total number of weight shifts are measured per day in each phase. The total number of weight shifts are normalized by dividing by the number of hours of wheelchair occupancy for each day. Then finally, for each phase, the normalized average weight shift frequency is calculated by averaging across the daily normalized weight shift frequency for each phase. | The outcome measure was assessed at week 4 (the end) of each intervention period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Hallbeck, PhD | Mayo Clinic | Principal Investigator |
| Tamara Vos-Draper, PhD, OT | University of Minnesota | Principal Investigator |
| Sharon Sonenblum, PhD | Georgia Institute of Technology | Principal Investigator |
| Melissa Morrow, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Institute of Technology | Atlanta | Georgia | 30332 | United States | ||
| University of Minnesota |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensoria First Intervention | Group 1 participants will receive the Sensoria intervention during the first intervention phase for 4 weeks, and then the AW-Shift intervention during the second intervention phase for 4 weeks. Sensoria: The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes. AW-Shift: The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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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 | Sep 19, 2022 |
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| AW-Shift | Behavioral | The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts. |
|
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| FG001 | AW-Shift First Intervention | Group 2 participants will receive the AW-Shift intervention during the first intervention phase for 4 weeks, and then the Sensoria intervention during the second intervention phase for 4 weeks. Sensoria: The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes. AW-Shift: The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts. |
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| Completed Baseline and Both Interventions | Includes participants who completed at least baseline and 2 intervention periods. This milestone should occur time-wise after the "Completed" milestone, but for analysis purposes it has been added as clarifying information per the comments. Participants who completed baseline and at least 1 intervention period are included as "Completed" and were analyzed. |
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| COMPLETED | Includes participants who completed at least baseline and 1 intervention period. |
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| NOT COMPLETED |
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Includes participants who completed baseline collection and at least 1 intervention who had usable data to analyze. Some participants were not appropriate for both interventions and may have only completed 1 intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensoria First Intervention | Group 1 participants will receive the Sensoria intervention during the first intervention phase for 4 weeks, and then the AW-Shift intervention during the second intervention phase for 4 weeks. Sensoria: The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes. AW-Shift: The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts. |
| BG001 | AW-Shift First Intervention | Group 2 participants will receive the AW-Shift intervention during the first intervention phase for 4 weeks, and then the Sensoria intervention during the second intervention phase for 4 weeks. Sensoria: The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes. AW-Shift: The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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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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| 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 | Normalized Weight Shift Frequency (Weight Shifts/Hour) | The normalized average weight shift frequency per hour of wheelchair occupancy for each intervention phase. For each day of the intervention phases, a total number of weight shifts are measured per day in each phase. The total number of weight shifts are normalized by dividing by the number of hours of wheelchair occupancy for each day. Then finally, for each phase, the normalized average weight shift frequency is calculated by averaging across the daily normalized weight shift frequency for each phase. | Analysis population for each arm includes participants who had usable data who completed that intervention, regardless of which was completed first. Some participants completed both interventions and will be included in both "arms". Some participants were not appropriate for both interventions and only completed 1, but were still included in analysis because they had usable data and completed at least 1 intervention period. | Posted | Mean | Standard Deviation | normalized weight shifts per hour | The outcome measure was assessed at week 4 (the end) of each intervention period. |
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Adverse events were collected before and after each intervention phase at approximately 2, 6, and 12 weeks after the start of the baseline phase of the study.
Participants at Risk for AE reporting cannot be provided for each intervention separately. Pts are allocated to each arm based on which intervention they completed first. However, some pts did not complete both interventions due to shortened timelines, drop out, or due to one of the interventions not being appropriate for the pt. We have analyzed all pts who completed baseline and 1 intervention who had usable data. Some of these participants completed both interventions, and some only 1.
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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 | Sensoria First Intervention | Group 1 participants will receive the Sensoria intervention during the first intervention phase for 4 weeks, and then the AW-Shift intervention during the second intervention phase for 4 weeks. Sensoria: The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes. AW-Shift: The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | AW-Shift First Intervention | Group 2 participants will receive the AW-Shift intervention during the first intervention phase for 4 weeks, and then the Sensoria intervention during the second intervention phase for 4 weeks. Sensoria: The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes. AW-Shift: The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts. | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Morrow | University of Texas Medical Branch | 409-266-0344 | memorrow@utmb.edu |
| Nov 3, 2023 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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