Identifying Patient-Centered Outcomes to Guide Use of Robotic Exoskeletons after

Spinal Cord Injury

Manon Maitland Schladen, MSE PhD

TQR 10th Annual Conference, NSU, Davie, FL January 17, 2019

Presentation “Pieces”

• Introduction, Framing of Research– 8 minutes

• Preliminary Findings– 8 minutes

• Formative Review (Audience has the floor!)– 4 minutes

Image - http://www.indego.com/indego/en/Indego-Personal

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Exoskeleton (XO) Study

Introduction

• Study context– Funded through the psychosocial

research (PSR) portfolio of the Craig H. Neilsen (CHN) Foundation

– CHN dedicated to supporting programs and scientific research to improve the quality of life for those affected by and living with spinal cord injury (SCI)

– Me: NSU alum. This study is the research component of my PSR fellowship from CHN (2018-2020).

https://www.youtube.com/watch?v=ZgbkSaiygmk

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Background & Problem• What an XO is/does

– a robotic technology that makes it possible for people with SCI to stand upright and walk.

• Face value of XO– to help people with SCI be

more mobile, and potentially get more satisfaction from life.

• Current state of XO research – Focused mostly on “Do XO

actually work?” versus “How can people with SCI best use this new technology?”

– Little is known about how to best use XO, which kinds, for which persons with SCI, and for what purposes.

ReWalker Community, Facebook

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Study Goal & Aims• Research Goal

– To better understand:• The experiences that people with SCI, their family members/

caregivers, and their clinicians have had with XO and• Their priorities for XO use

• Study Aims– SA1. Use iterative, semi-structured interviews to explore the

actual experience of persons with SCI and their clinicians with XO to generate subjective, user-defined themes.

• H1a: Persons with SCI and clinicians with experience using XO will identify some overlapping and some distinct areas of interest and importance.

– SA2. Apply degrees of freedom analysis (DoFA) to the user-defined themes from all users in SA1, to identify valid and reliable instruments (or gaps in such instruments) for assessing change in those themes.

• H2a: At least some themes identified in SA1 will correspond directly to at least one valid and reliable assessment instrument among the QUEST 2.0, ATDPA, PIADS, and the PYTHEIA (given validated English Language version).

• H2b: Gaps will be identified where new instruments are needed in order to capture salient features of the user experience (patient & clinician) with WREs. The themes to be obtained in SA1, after assessment through SA2, will support evidence-based decision-making around XO for people with SCI, and the development of a user-centered assessment instrument for XO inclusive of the psychosocial realm of experience.

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Methods• SA1

– Semi-structured interviews• Iterative, initial 1-hour and 2, 30-minute follow-ups• 30 people experienced with XO: 20 persons with SCI and

10 clinicians• Interview guide developed from exoskeleton usability

framework (Bryce, Dijkers, & Kozlowski, 2015)

– Interpretative Phenomenological Analysis (Smith, Flowers, & Larkin, 2009 )

• Key point, consider each case on its own, only then find cross-linkages

• SA2– Degrees of Freedom (DoFA) Analysis

• Campbell (1975) quantitative framework (matrix) to understand qualitative data

• Matches patterns between theoretical propositions and observations in a set of data (Wilson & Woodside, 1999)

• Theoretical propositions, here, are assistive technology assessment instruments: PIADS, PYTHEIA, QUEST 2.0, ATD PA

– Focus on the PIADS and PYTHEIA

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Why Assistive Technology Assessment Instruments?

Direct vs. Indirect Assistive Technology in the ICF Framework (Cowan et al., 2012)

7ICF = International Classification of Function

Why PIADS & PYTHEIA?PIADS (Psychosocial Impact of Assistive Devices Scale)• An assistive device should make

its user feel competent, confident, and inclined (or motivated) to exploit life’s possibilities.

• These 3 key dimensions have been determined empirically to underlie how users perceive the psychosocial impact of an AT.

• PIADS valid and widely used.• 26 items, 3 subscales:

competence, adaptability, self-esteem. – 7-point Likert scale

PYTHEIA (Greek acronym for?)

• QUEST 2.0 and ATD PA valid, but not specifically tuned to robotic devices.

• PYTHEIA builds on the QUEST 2.0 and ATDPA extending ability to assess at component level, assess rehab tech and specifically robotic tech. Validated in Greek version.

• PIADS only emphasizes the psychosocial impact of assistive devices, without targeting the evaluation of the actual experience of interacting with a robotic device.

• PYTHEIA – 2 general subscales: Fit to use (9 items) and ease of use (6 items). 5-item scale repeatable for individual functionalities.

– 6-point Likert scale

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Progress to Date

• 8 months into 2-year study• 12/20 consumer and 2/10 clinician

interviews completed• Currently, exploratory analysis of

selected patient/consumer case, Gabe Davis (pseudonym), underway

• Taming the devil in the methodological details

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Exploratory Analysis:

Gabe Davis

• How well did the PIADS and the PYTHEIA account for the themes generated by Gabe Davis’ XO experience?

• Consumer Profile– Male– Injury: T4 Complete

• This means he won’t get any additional function from therapy and insurance won’t pay for it

– Age at injury: 24– Duration of injury: 6 years– Device(s) used: Indego– Level of experience: > 8 weeks

• The rehab center’s “guinea pig” –Gabe’s term. He’s up for whatever they want to try!

– Home/community use: No• Device is not FDA approved for

people with injuries at Gabe’s level.

– Employed, highly engaged adaptive athlete, positive attitude, videos on YouTube

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Qualitative and Quantitative Procedure

• “In vivo” coding of memoed, verbatim transcript to PIADS and PYTHEIA items (QDAS, NVivo 12)

• ~a priori code book• Liberal match of whole ideas to items

• Cross-tabs export from NVivo to spreadsheet (Excel)

• Examine convergence, divergence

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DoFA FindingsItem Count Theme InstrumentPC18 35 Performance PIADSYF09 18 Sufficiency of existing functions PYTHIAPC06 17 Efficiency PIADSSP02 16 Happiness PIADSPC16 15 Capability PIADSPA15 14 Well-being PIADSPC13 14 Expertise PIADSPC17 14 Quality of Life PIADSPC11 12 Usefulness PIADSYF02 12 Contribution to Improvement, everyday life PYTHEIA

Item Count Theme InstrumentYF01 2 Adaptability to everyday spaces PYTHEIAYF07 2 Dimensions of Device PYTHEIAYE14 2 Comfort level using at work PYTHEIAYE12 2 Need for help using the device PYTHEIAPC08 1 Productivity PIADSPS10 1 Frustration PIADSPS12 1 Self-confidence PIADSYI04 1 Reliability PYTHEIAYF06 1 Security of device itself PYTHEIAYF08 1 Weight of device PYTHEIA

10 Most Frequently Matched Themes

10 Least Frequently Matched Themes

HITSPIADS: 221PYTHEIA: 85TOTAL*: 306

Themes Not Matched At All• Confusion (PIADS)• Ease of learning Basic

functions (PYTHEIA)

*Fewer coded concepts than hits, i.e. one-to-many matching scheme

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PYTHEIA

Individual Functionalities

Ease of UseFit To Use

Interpretation of low hits in Ease of Use construct: Use of XO to enhance everyday function not considered by Gabe. His context of use is different.

Not picked up by PIADS

(negative sentiment)

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Psychosocial rationale – perhaps

surprising?

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PIADS

Adaptability Competence Self-esteem

• Gabe focused on what the XO enabled him to do: Stand and walk upright

• Walking for its own sake, not mobility, with simultaneously occurring psychosocial themes:

• Happiness• Social participation of a certain quality• Quality of life

• Focus on walking as another adaptive sport drove focus on Competence – also possibly my line of questioning

“I find all rehab kind of fun, it's like a game.”

Not picked up by

PYTHEIA

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Contribution to Improvement in Everyday Life –Predominantly Psychosocial

• Quotes from Gabe’s interview, but typical of many others (not all)

– I think it's very hard to put into words, and for whatever reason, every time you go from the sitting position to the standing position, it gets me every time. It's very surreal.

– I think my purpose (for wanting to use the XO) is that I can actually stand up and be eye-to-eye with everyone. I think actually it motivates me the most to use it.

– It is, like you can give a real hug to somebody. It sounds so trivial, and like, little, but like, it goes very long way.

– To be face-to-face like, with your parents, or if you have a girlfriend, or a sibling … when you talk to someone, it's like, almost like a handshake too.

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Questions Resulting From Patterns Surfaced

Through DoFA

• Is the model of XO as an example of indirect and direct AT supported by experience?

• Mobility doesn’t seem to be the objective of use.

• Activity endorsed is aspirational, not “functional” as is understood by the standard framing of AT and its evaluation factors

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Different Emerging “Use Cases”• XO in the home and

community– Extension of function in the

true sense of AT possible, but not observed (in GD or other 11 consumers interviewed)

• XO in rehab– Therapy, to regain function

• Insurance does not cover if no functional gains anticipated

• XO for fun (joy, exercise etc.)– Intersects the two other use

cases– Fuels motivation, supporting

the essential nature of the psychosocial to XO success

Home

Rehab

Joy

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Weaknesses/Limitations

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Matching done by a sole researcher (me)

XO “dosage” not equal: different levels of experience; contexts, community, rehab; different devices

Focus of participant’s discourse influenced by interacting with me

No actual scores from instruments under consideration

Only one case (GD) matched to instruments so far. His use case is not the only one, for instance, does not take community use into consideration at all

Thematic analysis independent of instruments not yet done, might have yielded different results if not focused by instrument items

PYTHEIA has not been validated in English

ReferencesBryce, T. N., Dijkers, M. P., & Kozlowski, A. J. (2015). Framework for Assessment of the Usability of Lower-Extremity Robotic Exoskeletal Orthoses. Am J Phys Med Rehabil, 94(11), 1000-1014. doi:10.1097/phm.0000000000000321Campbell, D. T. (1975). “Degrees of Freedom” and the case study. Comp Polit Stud, 8, 178-193. Cowan, R. E., Fregly, B. J., Boninger, M. L., Chan, L., Rodgers, M. M., & Reinkensmeyer, D. J. (2012). Recent trends in assistive technology for mobility. J Neuroeng Rehabil, 9, 20-20. doi:10.1186/1743-0003-9-20Smith, J. A., Flowers, P., & Larkin, M. (2009). Interpretative Phenomenological Analysis: Theory, Method, and Research. London: Sage.Wilson, E. J., & Woodside, A. G. (1999). Data in business marketing research. Industrial Marketing Management, 28, 215-229.

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Thoughts?

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