Mobility Limitation
Conditions
Keywords
Pressure ulcers, wheelchairs, wheelchair functional capacity, custom-fitted wheelchair
Brief summary
The proposed clinical trial is aimed at demonstrating the important role wheelchairs play in preventing pressure ulcers (bed sores). Although most pressure ulcers can be prevented, they are common in nursing home settings because their causes are difficult to identify. This clinical trial will guide practitioners toward improving preventive care practices by demonstrating how to effectively apply wheelchair and seat cushion technology.
Detailed description
Pressure ulcers are a significant healthcare problem for the growing number of nursing home residents in the United States and around the world. Pressure ulcers diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs. Costs for the management of pressure ulcers in the US likely exceeds $6.4 billion annually, with a prevalence of approximately 12% in the high risk LTC population. A previous clinical trial at the University of Pittsburgh studied the effects of seat cushions on pressure ulcer incidence and found that when a skin protection seat cushion is used with a properly fitted wheelchair there is a significant reduction in incidence. The data led the investigators to question whether having a properly fitted wheelchair also has a significant effect on pressure ulcer incidence. This clinical trial investigate this question by randomizing subjects into a control group that receives a skin protection cushion and wheelchair training for use in their facility supplied wheelchair, or a treatment group that receives a skin protection cushion, wheelchair training and a new custom-fitted wheelchair. We expect that the treatment group will have a lower incidence of pressure ulcers.
Interventions
DEVICELightweight wheelchair
Seating and wheeled mobility assessment and fitting of a lightweight wheelchair
DEVICESkin Protection Cushion
Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female nursing home resident 60 years of age and older 2. A Braden score of less than or equal to 18 3. A combined Braden Activity and Mobility Subscale score less than or equal to 5 4. Absence of ischial and sacral area pressure ulcers (see definition of pressure ulcer) 5. A tolerance for total daily wheelchair sitting time of greater than or equal to 6 hours (not continuous) 6. Ability to accommodate seating and positioning needs with the wheelchair selected for use in this study (Breezy Ultra 4) 7. Informed written consent
Exclusion criteria
1. Body weight exceeding 250 lbs. 2. Hip width exceeding 20 in. 3. Wheelchair seating requirements for additional head support, seat depth \> 20 inches, elevated leg rests or severe orthopedic deformities of the pelvis, lower extremities or back that exceed the accommodating capability of the Breezy Ultra 4 wheelchair. 4. Current use of any cushioning material(s) other than a standard cushion, a folded pad, or a pillow (standard cushion as defined by HCPCS code for Standard Cushions, i.e., non-skin protection cushion) 5. Current use of a HCPCS code K0004 wheelchair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of a Sitting-induced Pressure Ulcer | 182 days | Skin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 127 |
| 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 | 131 |
| Total | 258 |
Baseline characteristics
| Characteristic | Custom-Fitted Lightweight Wheelchair & Cushion | Cushion Only | Total |
|---|---|---|---|
| Age, Continuous | 89.0 years STANDARD_DEVIATION 8.7 | 89.1 years STANDARD_DEVIATION 9.2 | 89.0 years STANDARD_DEVIATION 8.9 |
| Ambulation Distance 0 ft | 63 Participants | 77 Participants | 140 Participants |
| Ambulation Distance <= 10 ft | 28 Participants | 22 Participants | 50 Participants |
| Ambulation Distance >10 ft | 36 Participants | 31 Participants | 67 Participants |
| Ambulation Distance Unknown | 0 Participants | 1 Participants | 1 Participants |
| Body Mass Index (BMI) | 26.0 kg/m^2 STANDARD_DEVIATION 5.2 | 26.9 kg/m^2 STANDARD_DEVIATION 5.8 | 26.5 kg/m^2 STANDARD_DEVIATION 5.5 |
| Incontinent | 102 Participants | 95 Participants | 197 Participants |
| Kyphosis Fixed deformity | 32 Participants | 29 Participants | 61 Participants |
| Kyphosis Flex deformity | 65 Participants | 64 Participants | 129 Participants |
| Kyphosis Neutral | 26 Participants | 26 Participants | 52 Participants |
| Kyphosis Unknown | 4 Participants | 12 Participants | 16 Participants |
| Lordosis Neutral | 123 Participants | 119 Participants | 242 Participants |
| Lordosis Unknown | 4 Participants | 12 Participants | 16 Participants |
| Patient alert and oriented | 114 Participants | 116 Participants | 230 Participants |
| Pelvic Obliquity fixed deformity | 3 Participants | 5 Participants | 8 Participants |
| Pelvic Obliquity Flex deformity | 18 Participants | 21 Participants | 39 Participants |
| Pelvic Obliquity Neutral | 102 Participants | 93 Participants | 195 Participants |
| Pelvic Obliquity Unknown | 4 Participants | 12 Participants | 16 Participants |
| Pelvic Rotation Fixed deformity | 2 Participants | 4 Participants | 6 Participants |
| Pelvic Rotation Flex deformity | 24 Participants | 28 Participants | 52 Participants |
| Pelvic Rotation Neutral | 97 Participants | 87 Participants | 184 Participants |
| Pelvic Rotation Unknown | 4 Participants | 12 Participants | 16 Participants |
| Pelvic tilt Fixed deformity | 27 Participants | 22 Participants | 49 Participants |
| Pelvic tilt Flex deformity | 64 Participants | 62 Participants | 126 Participants |
| Pelvic tilt Neutral | 32 Participants | 35 Participants | 67 Participants |
| Pelvic tilt Unknown | 4 Participants | 12 Participants | 16 Participants |
| Previous history of pressure injury | 27 Participants | 17 Participants | 44 Participants |
| Scoliosis Fixed deformity | 11 Participants | 13 Participants | 24 Participants |
| Scoliosis Flex deformity | 23 Participants | 23 Participants | 46 Participants |
| Scoliosis Neutral | 89 Participants | 83 Participants | 172 Participants |
| Scoliosis Unknown | 4 Participants | 12 Participants | 16 Participants |
| Sensation Absent | 1 Participants | 0 Participants | 1 Participants |
| Sensation Diminished/Questionable | 26 Participants | 31 Participants | 57 Participants |
| Sensation Normal | 96 Participants | 88 Participants | 184 Participants |
| Sensation Unknown | 4 Participants | 12 Participants | 16 Participants |
| Sex: Female, Male Female | 97 Participants | 105 Participants | 202 Participants |
| Sex: Female, Male Male | 30 Participants | 26 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 127 | 5 / 131 |
| other Total, other adverse events | 0 / 127 | 0 / 131 |
| serious Total, serious adverse events | 0 / 127 | 0 / 131 |
Outcome results
Primary
Incidence of a Sitting-induced Pressure Ulcer
Skin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days
Time frame: 182 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Custom-Fitted Lightweight Wheelchair & Cushion | Incidence of a Sitting-induced Pressure Ulcer | Death | 8 Participants |
| Custom-Fitted Lightweight Wheelchair & Cushion | Incidence of a Sitting-induced Pressure Ulcer | Seating surface pressure injury | 19 Participants |
| Custom-Fitted Lightweight Wheelchair & Cushion | Incidence of a Sitting-induced Pressure Ulcer | 26 weeks since initiation of seating intervention | 75 Participants |
| Cushion Only | Incidence of a Sitting-induced Pressure Ulcer | Seating surface pressure injury | 15 Participants |
| Cushion Only | Incidence of a Sitting-induced Pressure Ulcer | 26 weeks since initiation of seating intervention | 69 Participants |
| Cushion Only | Incidence of a Sitting-induced Pressure Ulcer | Death | 5 Participants |
Comparison: Null hypothesis: At-risk nursing home residents provided with an individually-configured manual lightweight wheelchair and skin protection cushion have the same incidence of pressure injury development compared to individuals using a facility-provided manual wheelchair modified with a skin protection cushion and related adjustments.p-value: 0.77Chi-squared, Corrected