Custom Clinical Testing Knee Brace Device
From conception to clinical implementation.
I designed, fabricated and validated a custom Biodex knee brace attachment for spasticity testing from conception to clinical implementation. The Biodex chair uses various attachments to move different joints in the body. While troubleshooting spasticity testing, we realized that the knee joint needed to remain constant while the hip joint was in motion- no current Biodex attachments allowed for this. I was tasked with the development of a compatible device that achieved constant knee angle while allowing for motion of the hip under a tight one month timeline in order to meet clinical trial deadlines. I created a detailed project timeline and milestones in order to complete the project on time.
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Firstly, multiple design iterations were developed and metrics of success were established as per engineering design. Prototypes were fabricated of the selected design, tested with the Biodex experimental setup and assessed against defined metrics. After modifications of the design, a CAD model was created.
Figure 1: Completed Design
Fabrication involved acrylic laser cutting, metal soldering, 3D printing, foam cutting and upholstering for comfort. Costs were proposed to the principal investigator and approved.
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The fabricated design was then tested against metrics outlined in Figure 5 with the Biodex machine, passing all metrics. Measurements of the Biodex were taken to ensure compatibility.
Figure 3: Acrylic and Soldered Base
Figure 2: Biodex Chair
Figure 3: Design in testing (minimal knee joint movement)
Figure 4: Original insufficient setup (knee unsupported)
The device successfully maintained the knee angle and was compatible with the Biodex chair. Furthermore, the design visually matched the standard Biodex attachment (Figure 4).
Figure 5: Objectives and Metrics of Design
Finally, the design was approved by a senior clinical-scientist (MD and BEng). The high quality of the design is evidenced through the senior clinical-scientists thinking it was professionally designed by the Biodex company before we informed the individual that it was a custom design. The device is now implemented in clinical testing and was completed before the one month deadline. Below is the device being used in clinical testing.
Figure 6: Clinical device setup
Figure 7: Clinical Testing (I am recording and monitoring blood pressure)
