By Eric Bubar
When I learned that e-NABLE devices are considered “Class 1 Exempt,” I started looking into how a number of outcome measures can apply to commercially available prosthetics and how these methods can/should be applied to e-NABLE. The International Classification of Functioning Disability and Health (ICF) offers 4 categories of assessments applicable to e-NABLE’s purposes: body function and structure, activities and participation, environmental factors, and personal factors.
CATEGORY 1: Body Function and Structure – Assessing outcomes in this category typically means applying engineering tests to devices. This is where we can evaluate areas like grip strength, fingertip friction, and strength to actuate. Customarily, device designers and fabricators would concentrate on this category.
CATEGORY 2: Activities and Participation – These outcomes relate to the activities of daily living (ADL’s) that can be accomplished with a prosthetic device. What kinds of tasks are recipients using devices for, and what kinds of tasks could they be adapted to perform? Here, we must assess whether people actually use their devices. Prosthetic rejection can be relatively high. It is important to learn why so that e-NABLE designs can avoid some problems known to exist with prosthetics. This information would typically be obtained through collaboration between the device provider, medical professionals, and device users.
CATEGORY 3 and 4: Environmental Factors and Personal Factors – Environmental and personal factors are highly recipient-focused. Validated surveys are the typical method for measuring outcomes in these categories.
This process requires a bit of care in protecting the interests of the recipients. It must be done with proper oversight to comply with federal regulations regarding research with vulnerable populations. To measure (and learn!) from these outcomes, researchers need approval from entities known as Institutional Review Boards (IRBs). There is a subset within e-NABLE that has done great work towards obtaining these IRB approvals.
There are standardized, validated tests that apply to each of these categories. To prove these devices’ transformative and useful power, we first need to apply these standards to their assessment. If they pass, great. If not, then this systematic collection of data can help designers improve functionality until e-NABLE devices are desirable for their customization options and their proven functionality!
What are these tests? How can volunteers apply them? How can you help assess devices? Reach out to firstname.lastname@example.org or through the various e-NABLE Facebook resources to discuss ideas and start new collaborations!