Maximum load testing was conducted on an iteration of the device prior to phasing out the hinge design. The device was able to support a load of 145 lbs before sustaining significant fracture and failure of both of the PETG hinges. As engineers with minimal resources, we got creative with testing - shown here is Ian at the RecWell with our experimental loading set up. Weights were incrementally stacked on top of the device with the hinges in the fully extended (vertical) position. Slight damage to the toe area of the foot plate was also sustained during the test, but only as a result of the testing weights falling and crushing it when the hinges collapsed.
With the hinges as the limiting factor for device strength and stability, it was determined that phasing this component out of the design was a prudent step to take in the iterations of our device. As seen in this selection of photos, the hinges cracked, sheared, and snapped in a variety of places when 145 pounds was reached.
To ensure proper slip resistance of the foot plate, the coefficient of static friction was measured on a variety of flooring surface types. Generally, a coefficient of friction around 0.4-0.5 or higher is regarded as good traction for shoe soles. Our device performed with a coefficient of 0.5 or greater on all tested surfaces.
Ultimate strength and cyclic fatigue testing were performed on the telescoping poles of our second prototype iteration. Since the hinges were removed in this new iteration, the maximum load testing was repeated without the hinges as the limiting factor for strength. Both testing methods were measured using a INSTRON universal testing machine. For maximum load testing, a telescoping pole was secured in a vertical position on the bed of the INSTRON, and the load cell was lowered on to the pole at a rate of 5 mm/min to test the pole's maximum compressive load. The poles were able to withstand a compressive force of 5kN (1124 lbs.) without failure, reaching the maximum capacity of the load cell. The only sign of deformation was a slight compression of the pins that adjust the height of the telescoping poles. This component of the device far surpassed our intended weight maximum of 250 pounds, resulting in a safety factor of ~4.5.
Cyclic testing was performed on the other, identical set of telescoping poles at a rate of 30 cycles per minute with a load of 125 pounds. While the ideal amount of testing cycles was determined to be 500,000 based on estimated patient usage, the machine was only available to perform 7650 cycles. At the maximum machine rate, completing 500,000 cycles would've taken 11.5 days to complete, which was not feasible for the team or the lab which offered us the use of their machine. Only slight elongation of the pin was observed over the cycles performed, but the device was still functional and safe. Thank you to Dr. Arin Ellingson and the Minnesota Rehabilitation Biomechanics Lab for the use of their testing machine.
Testing was performed on subjects using the device while wearing an accelerometer strapped to the outside of their knee. Acceleration data was collected as the patient walked 5 steps wearing the device (right figure below) and compared with data collected from the patient as they walked 5 steps with a natural gate (left figure). A least-squares-regression was then used to compare the two sets of data and determine relative stability.
The x-axis (user's sagittal plane) acceleration data was analyzed from the accelerometer because it lends the most information about the subject’s gait. The R-squared value between the two x-axis acceleration sets of data is 0.0018. This result indicates that gait with the device is significantly different from normal.
This data confirms the need of a traditional assist device, such as a cane, to be used in conjunction with the current iteration of our device to improve the patient's stability.
To test the device's functionality, each member donned the device and attempted to walk down a hallway with a tile floor at full weight bearing capacity. Every team member was able to lift and walk with the device without falling, indicating our prototype was both lightweight and stable.
In regards to comfort, every team member expressed dissatisfaction with the seat design. While the seat was made out of foam to provide a comfortable surface to sit on, the foam chosen was not dense enough to resist compression from the weight of each user, so users were in nearly direct contact with the metal bar embedded in the seat. To address this issue, the team constructed the final prototype's seat out of a denser foam to improve comfort.
Another issue is that the device can only be donned and doffed when the patient was standing up. Additionally, attempting to don and doff the device without placing load on the injured leg was very difficult for all team members and required assistance to be done effectively. In future device iterations, the seat mount and upper frame may need to be changed to allow donning and doffing while sitting down (preferred), or the method of attachment may need to be altered so patients can effectively and safely don and doff while standing up.
In order to validate our product design, the team produced surveys to send to potential customers and clinicians for constructive feedback. Each survey was written to appeal to the target demographic’s working knowledge and potential interaction with the final product. This was achieved in the customer survey by providing a general overview of the device and asking questions on how the patient would feel using the device, while the clinical survey dives more in depth into the design and asks clinicians to indicate situations in which the device would be most beneficial.
Each survey provided the participant with a series of qualitative and quantitative questions. The qualitative questions allowed participants to express their views on the device and offer any critiques, praises, or potential improvements, while the quantitative questions allowed the team to measure our device’s perceived quality on a numerical scale. The results from the quantitative sections of the survey are shown in the two displayed tables. While the clinicians were overall more critical of the device design compared to the customers, the lowest scoring categories for both surveys were the ease of use, comfortability, and safety questions, revealing that both groups seem to have similar concerns with the current device design.
In the qualitative section of the survey, customers identified hands free usage, side stabilization with the footplate and seat mount, and the overall structural stability as the prototype's best features. Common responses for prototype concerns included the seat’s comfortability, the fact that the user could not sit down in a chair with the device on, and the possibility that the size of the device may make it difficult to walk naturally. Clinicians indicated the seat support, adjustable height, and support around the thigh as the best features of the device, while the seat’s comfort level, perceived functionality, set up difficulty, and the absence of a knee joint as areas of concern.