Trial Outcomes & Findings for Wheeled Mobility for Preventing Pressure Ulcers (NCT NCT01275313)
NCT ID: NCT01275313
Last Updated: 2022-06-28
Results Overview
Skin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
258 participants
Primary outcome timeframe
182 days
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
Custom-Fitted Lightweight Wheelchair & Cushion
Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair
|
Cushion Only
Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair
Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
131
|
|
Overall Study
COMPLETED
|
102
|
79
|
|
Overall Study
NOT COMPLETED
|
25
|
52
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wheeled Mobility for Preventing Pressure Ulcers
Baseline characteristics by cohort
| Measure |
Custom-Fitted Lightweight Wheelchair & Cushion
n=127 Participants
Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair
|
Cushion Only
n=131 Participants
Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair
Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
89.0 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
89.1 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
89.0 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.0 kg/m^2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 5.8 • n=7 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Incontinent
|
102 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Previous history of pressure injury
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Patient alert and oriented
|
114 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Ambulation Distance
0 ft
|
63 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Ambulation Distance
<= 10 ft
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ambulation Distance
>10 ft
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ambulation Distance
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sensation
Normal
|
96 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Sensation
Diminished/Questionable
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sensation
Absent
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sensation
Unknown
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Scoliosis
Neutral
|
89 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Scoliosis
Flex deformity
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Scoliosis
Fixed deformity
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Scoliosis
Unknown
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Kyphosis
Neutral
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Kyphosis
Flex deformity
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Kyphosis
Fixed deformity
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Kyphosis
Unknown
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Lordosis
Neutral
|
123 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Lordosis
Unknown
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Pelvic tilt
Neutral
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Pelvic tilt
Flex deformity
|
64 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Pelvic tilt
Fixed deformity
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Pelvic tilt
Unknown
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Pelvic Rotation
Neutral
|
97 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Pelvic Rotation
Flex deformity
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Pelvic Rotation
Fixed deformity
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Pelvic Rotation
Unknown
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Pelvic Obliquity
Neutral
|
102 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Pelvic Obliquity
Flex deformity
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Pelvic Obliquity
fixed deformity
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Pelvic Obliquity
Unknown
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 182 daysSkin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days
Outcome measures
| Measure |
Custom-Fitted Lightweight Wheelchair & Cushion
n=102 Participants
Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair
|
Cushion Only
n=89 Participants
Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair
Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion
|
|---|---|---|
|
Incidence of a Sitting-induced Pressure Ulcer
Seating surface pressure injury
|
19 Participants
|
15 Participants
|
|
Incidence of a Sitting-induced Pressure Ulcer
26 weeks since initiation of seating intervention
|
75 Participants
|
69 Participants
|
|
Incidence of a Sitting-induced Pressure Ulcer
Death
|
8 Participants
|
5 Participants
|
Adverse Events
Custom-Fitted Lightweight Wheelchair & Cushion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Cushion Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place