Our project involves designing an assistive device to support and brace our patient as he watches TV and may fall asleep on the edge of the bed. To begin, we first researched the key information provided by our project partner Walter Guminiak (and co-therapist Velarie Pech), physical therapists at the Shirley Ryan AbilityLab. As detailed in the project description, the user has weakness in both of his legs as well as his left arm due to his cerebral palsy and will often sleep while watching TV from the edge of his bed. Usually, he falls backwards into the safety of his bed, but at times will slip forwards and fall out of bed. To better understand the needs and parameters of design for our user, we investigated (1) cerebral palsy, (2) current supportive methods, (3) the hazards and ethical concerns for existing safety measures, (4) and our objective design features for a satisfactory solution.
Figure 1: Stages of musculoskeletal development in children with spastic cerebral palsy [9]
Cerebral Palsy
Cerebral palsy is a selection of disorders that occur as a result of damage to the brain during developmental stages, most often during the prenatal period. These disorders come with a plethora of effects most commonly associated with movement, muscle tone, and posture [2]. Mobility is usually restricted as a child, and the bone torsion coupled with soft tissue results in underdevelopment of the skeletal structure as seen in [9, Fig. 1]. While the onset of cerebral palsy occur at an early age, common symptoms of cerebral palsy within adults include:
Osteoporosis (low bone density occurs in 80-90% of individuals with cerebral palsy)
Spasticity (occurs in 80% of individuals with cerebral palsy)
Skeletal or muscular pain (occurs in 75% of individuals with cerebral palsy)
Intellectual disability (occurs in 50% of individuals with cerebral palsy)
Hip displacement and an inability to walk (occurs in 33% of individuals with cerebral palsy) [1]
Cerebral palsy occurs in around two or three of every 1,000 childbirths, which currently results in a million individuals with cerebral palsy in the United States alone. Globally, this is magnified to a total of 17 million people with cerebral palsy [8]. With this condition being prevalent on such a large scale, many of these individuals receive physical therapy to rebuild stability in their bodies.
Current Supportive Methods
Adjustable Bed Back Support
An adjustable back support, a brace that works as a makeshift chair, keeps the user stabilized in an upright position. The pegs on the bottom of the apparatus allow the user to adjust the height and angle as preferred, allowing for maximum comfortability [5, Fig. 2]. However, since the support is being placed on a presumably soft home bed, the support will move around unless it is properly braced. Therefore, the bed back support is not necessarily practical as it will not effectively prevent the user from sliding out of bed when falling asleep [project description].
Figure 2: Patent of an adjustable back support issued in 1969 [5]
Foam Bed Wedge
The foam bed wedge is originally designed to be a “guard rail” oriented laterally (longways), supporting the user when they are lying prone [6]. To apply this device specifically to the scope of this problem, we would set the wedge under the user’s knees while seated to remove any forward motion. Similar to the back support, the wedge is too soft and when not stabilized, provides no realistic bracing for the user as shown in [3, Fig. 3]. Additionally, without a support system on the user’s back, the user has to be in constant knee flexion and lower back tension to remain upright, which would only serve to exacerbate his existing pain [10].
Figure 3: Users use the wedge to support their bodies when asleep [3]
Folding Bed Rail
To prevent the user from sliding off the bed and acting as handrail for additional mobility, the folding bed rail can be utilized as indicated in [7, Fig. 4]. The user can stabilize himself and grab the rail in the case that they slip forward when falling asleep. While this does eliminate one parameter of the problem, adult bed rails can be extremely hazardous. They are not designed to be a restraint and instead should be purely assistive to ensure that the user does not come into hazardous contact with the rail [11].
Figure 4: Patent of a collapsible bed rail issued in 1961 [7]
Folding Bed Rail
To prevent the user from sliding off the bed and acting as handrail for additional mobility, the folding bed rail can be utilized as indicated in [7, Fig. 4]. The user can stabilize himself and grab the rail in the case that they slip forward when falling asleep. While this does eliminate one parameter of the problem, adult bed rails can be extremely hazardous. They are not designed to be a restraint and instead should be purely assistive to ensure that the user does not come into hazardous contact with the rail [11].
Figure 5: An example of a buckled anti-fall belt [4]
Hazards and Ethical Concerns for Existing Safety Measures
Bed Rails
As described above, bed rails are stiff metal bars that prevent the potential extraneous movement from the user to stop the user from falling off the bed. However, these bars can pose an extreme risk when using them as bed restraints, particularly to users with intellectual or physical limitations. According to the U.S. Consumer Product Safety Commission, over the course of nine years, 155 deaths linked to adult bed rails were reported. From these 155 deaths, 129 of them were from an older age group, likely denoting limited mobility, and over half of the deaths were individuals with diagnosed medical conditions. Additionally, 94 of these deaths occurred at home, where caretakers or other staff cannot attend to the use [11]. This applies directly to the primary user entailed within the project description, so it is necessary for our solution to absolutely guarantee the safety of the user.
Bed Restraints
Restraints can be a simple fabric belt or nylon ankle straps that anchor the user in a fixed position on the bed. While they do have ample upside when focusing strictly on keeping the user from sliding off the bed, the physical hazards and ethical issues are important to consider. Studies regarding restraints indicate that restraints neither decrease the number of falls nor remove the risk from injury. While using restraints, 20 deaths were reported to the Joint Commission on Accreditation of Healthcare Organizations over a two year period, most of which were due to asphyxiation [12]. If not as extreme as death, restraints have acute negative physical consequences including tissue injury, immobility, and pressure ulcers. Users of restraints have also shown frequent cases of negative psychological effects such as agitation, disorientation, trauma, delusional memories, and even post-traumatic stress disorder from perpetual anxiety [13].
Objective
Through our secondary research, we have investigated the necessary parameters for our solution and have narrowed down several preliminary requirements to create a suitable edge of bed support for our primary user. The essential qualities that we have determined include that the device is ideally independent, efficiently operated with minimal mobility, and ensures the user’s physical and mental safety when preventing him from sliding off of the bed. The overarching goal is to create an assistive device that meets all the requirements and sufficiently prevents the user from falling forward off of the bed. Moving forward, by interviewing and meeting with both the client and the user, we will be able to identify which requirements apply specifically to our primary user and therefore narrow down the scope of this secondary research.