Shoe Donning Assist Device
Senior Capstone Project
Project Overview
Goal: Create a medical device as a solution to an identified unmet clinical need. Work on a multidisciplinary team of 8 members.
Phases of development:
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Ethnography
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Prototyping
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IRB approval
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Verification testing (future)
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Validation testing (future)
Individual contributions:
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Use case documents
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Risk summary
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Design expo poster
Device Overview
Unmet clinical need: Patients who have suffered a stroke commonly experience limited mobility and foot drop, requiring an ankle foot orthosis (AFO) brace. Patient independence is limited regarding donning shoes over the brace.
Intended use: To assist in donning of shoes and tying shoelaces to improve ease-of-use of donning and shoe-tying for patients with impaired mobility and/or dexterity.
Indications for use: For patients
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With muscular degenerative diseases such as congenital muscular dystrophy (CMD)
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With neurological degenerative diseases such as a stroke or Parkinson’s diseases
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With neuromuscular degenerative diseases such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS).
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Who use an AFO (Ankle-Foot Orthosis) brace, regardless of the reasoning
Ethnography
Met with Occupational Therapists from UPMC, to identify an unmet clinical need for the basis of our project. Also spoke with occupational therapy students from Pitt SHRS for further advice and ideas.
Learned about an issue of regaining independence for patients who suffer strokes and suffer from limited mobility and foot drop condition. Foot drop requires the use of an ankle foot orthosis (AFO) brace which makes shoe donning challenging.
Prototype Development
Low resolution prototype- developed from foamboard, velcro straps, and close pins. Cut and assembled foamboard.
Medium resolution protype- developed from laser cut hardboard and CNC cut plywood. Assisted in developing new parts and assembly.
High resolution prototype- replaced certain components with metal materials for better structural integrity. Sewed strap to hold shoe to platform.
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Final design components
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adjustable platform
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velcro straps
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clip to hold shoe tongue back
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Documentation
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Use cases (individually completed), user needs
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Regulatory strategy (based on FDA requirements)
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Hazard and risk analysis
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FTA
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FMEA
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Risk summary (individually completed)
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Verification and validation test protocols and reports
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eQMS & traceability matrix
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Poster to present at engineering design expo (completed with one other team member)
Verification Testing
Several verification tests were performed to ensure that the finalized design successfully met all of the chosen design specifications. The following tests were performed by following written test protocols and test reports were generated afterward: physical size and mass requirements, total weight, physical size measurement, angle measurement, clip range, device slip, foot slip, absorbance, cleanability, and shoe constraint. I was individually responsible for completing the physical size measurement and clip range tests as described below.
Physical Size Measurement
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Using several measurements I verified that the the length, width, height, and protrusions of the device met the following acceptance criteria:
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Length between 12-14 inches
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Width between 6-7 inches
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Height between 3-4 inches
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Protrusions less than 3 inches
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The acceptance criteria was met
Clip Range
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The length of the clip attachments were measured to determine that each reached at least halfway to each long end of the platform from the middle point
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The acceptance criteria was met
Validation Testing
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Usability Testing with Occupational Therapists
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We tested 4 OTs in patient training of the device
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Validated the user needs specific to OTs
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Patient Usability Testing
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We tested 3 stroke patients using the device after they were trained on instructions for use by the OTs
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Most acceptance criteria was met
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Validated the user needs specific to patients
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Our validation testing lead developed the test plan, protocols and reports
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I was responsible for 1 of the 3 patient usability testing sessions which occurred at an outpatient rehabilitation center (no photos were taken at this per patient privacy)
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