Trial Outcomes & Findings for Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users (NCT NCT04934137)

Last Updated: 2024-02-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

The outcome measure was assessed at week 4 (the end) of each intervention period.

Results posted on

2024-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	23	23
Overall Study Completed Baseline and Both Interventions	15	14
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Development of Technologies to Increase In-Seat Movement to Prevent Sitting-Acquired Pressure Injuries in Wheelchair Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sensoria First Intervention n=18 Participants 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.	AW-Shift First Intervention n=12 Participants 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.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	48.83 years STANDARD_DEVIATION 14.21 • n=5 Participants	42.92 years STANDARD_DEVIATION 12.00 • n=7 Participants	46.47 years STANDARD_DEVIATION 13.48 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	12 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: The outcome measure was assessed at week 4 (the end) of each intervention period.

Population: 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.

Outcome measures

Outcome measures
Measure	Participants Who Completed Sensoria Intervention n=27 Participants Group 1 participants will receive the Sensoria intervention during 4 weeks of the study. This includes all participants who used Sensoria regardless of which intervention they used first. 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.	Participants Who Completed AW-Shift Intervention n=18 Participants Group 2 participants will receive the AW-Shift intervention during 4 weeks of the study. This includes all participants who used AW-Shift regardless of which intervention they used first. 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.
Normalized Weight Shift Frequency (Weight Shifts/Hour)	2.41 normalized weight shifts per hour Standard Deviation 1.93	2.38 normalized weight shifts per hour Standard Deviation 2.03

Adverse Events

Sensoria First Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AW-Shift First Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Melissa Morrow

University of Texas Medical Branch

Phone: 409-266-0344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place