Measuring Satisfaction With Upper Limb Prostheses: Orthotics and Prosthetics User Survey Revision That Includes Issues of Concern to Women.

OBJECTIVE: To (1) modify the Orthotics and Prosthetics User Survey (OPUS) Client Satisfaction with Device (CSD) instrument to incorporate issues of concern to women and (2) evaluate measure's structural and concurrent validity and reliability in persons with upper limb amputation (ULA). DESIGN: Cross-sectional survey study with retest after 2 weeks. Exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and Rasch analyses were used to select items and examine differential item functioning, range of coverage, and person and item reliability. Test-retest reliability was evaluated with intraclass correlation coefficients. Pearson correlations were used to estimate associations with other prosthesis satisfaction measures. SETTING: Telephone administered survey. PARTICIPANTS: Convenience sample of 468 participants in the US (N=468; 19.9% women) with ULA, including a 50-person retest subsample (4% female). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Modified OPUS CSD. RESULTS: EFA suggested 3 subscales: Comfort, Appearance, and Utility. CFA found acceptable model fit. After dropping items with poor fit and high pairwise correlations in Rasch partial credit models, CFA model fit indices were acceptable (comparative fit index=0.959, Tucker-Lewis Index=0.954, root mean square error of approximation=0.082). Rasch person reliability was 0.62 (Utility), 0.77 (Appearance), and 0.82 (Comfort). Cronbach α was 0.81, 87, and 0.71 for Comfort and Appearance, and Utility subscales, respectively. Correlations between the modified CSD, the original CSD, and the Trinity Amputation and Prosthesis Experience Satisfaction Scale were 0.54-0.94. CONCLUSIONS: We identified 3 subscales: Comfort (6 items), Appearance (8 items), and Utility (4 items) with 7 new items identified as important to women. The subscales demonstrate evidence of sound concurrent structural and test-retest reliability and concurrent validity. The Appearance and Comfort subscales have good reliability for group-level use in clinical and research applications, whereas the Utility subscale had poor to fair person reliability but excellent item reliability.

Can an Emergency Department-Initiated Intervention Prevent Subsequent Falls and Health Care Use in Older Adults? A Randomized Controlled Trial.

STUDY OBJECTIVE: We determine whether an emergency department (ED)-initiated fall-prevention intervention can reduce subsequent fall-related and all-cause ED visits and hospitalizations in older adults. METHODS: The Geriatric Acute and Post-acute Fall Prevention intervention was a randomized controlled trial conducted from January 2018 to October 2019. Participants at 2 urban academic EDs were randomly assigned (1:1) to an intervention or usual care arm. Intervention participants received a brief, tailored, structured, pharmacy and physical therapy consultation in the ED, with automated communication of the recommendations to their primary care physicians. RESULTS: Of 284 study-eligible participants, 110 noninstitutionalized older adults (≥65 years) with a recent fall consented to participate; median age was 81 years, 67% were women, 94% were white, and 16.3% had cognitive impairment. Compared with usual care participants (n=55), intervention participants (n=55) were half as likely to experience a subsequent ED visit (adjusted incidence rate ratio 0.47 [95% CI 0.29 to 0.74]) and one third as likely to have fall-related ED visits (adjusted incidence rate ratio 0.34 [95% CI 0.15 to 0.76]) within 6 months. Intervention participants experienced half the rate of all hospitalizations (adjusted incidence rate ratio 0.57 [95% CI 0.31 to 1.04]), but confidence intervals were wide. There was no difference in fall-related hospitalizations between groups (adjusted incidence rate ratio 0.99 [95% CI 0.31 to 3.27]). Self-reported adherence to pharmacy and physical therapy recommendations was moderate; 73% of pharmacy recommendations were adhered to and 68% of physical therapy recommendations were followed. CONCLUSION: Geriatric Acute and Post-acute Fall Prevention, a postfall, in-ED, multidisciplinary intervention with pharmacists and physical therapists, reduced 6-month ED encounters in 2 urban EDs. The intervention could provide a model of care to other health care systems aiming to reduce costly and burdensome fall-related events in older adults.

Psychometric Properties of Functional, Ambulatory, and Quality of Life Instruments in Lower Limb Amputees: A Systematic Review.

OBJECTIVE: Summarize the psychometric properties of functional, ambulatory, and quality of life instruments among adult lower limb amputees, highlighting evidence deemed generalizable to the United States Medicare population. DATA SOURCES: Six databases and existing systematic reviews through October 30, 2017. Searches included terms for lower limb amputation or prostheses and outcome measures in humans, without language restriction. STUDY SELECTION: We included peer-reviewed studies of at least 20 adults (≥18 years) with lower limb amputation. Eligible studies reported on psychometric properties of functional, ambulatory, or quality of life instruments. Fifty-three of 425 retrieved articles (12%) met criteria. DATA EXTRACTION: Study characteristics and psychometric property data (validity, reliability, responsiveness, minimum detectable change, minimal important difference, or floor or ceiling effect) were extracted into a customized form based on standardized criteria. All extracted data were confirmed by 2 experts in systematic review and rehabilitation outcome measurement. Instruments were categorized regarding having been validated and found reliable. Other reported psychometric properties were recorded. Studies were also assessed for applicability to the Medicare population based on age and amputation etiology (dysvascular). DATA SYNTHESIS: Fifty-six studies (in 53 articles) reported psychometric properties of 50 instruments. There is evidence for both validity and reliability for 30 instruments, 17 of which have evidence that was deemed generalizable to the Medicare population. Most of the remaining instruments have evidence of either validity or reliability, but not both. Twelve instruments have been assessed specifically among lower limb amputees prior to prosthesis prescription. Thirteen instruments have been assessed regarding their predictive properties for future outcomes. CONCLUSIONS: Numerous instruments assessing ambulation, function, quality of life, and other patient-centered outcomes have evidence of validity and reliability for adults with lower limb amputations. Researchers and clinicians should use validated, reliable instruments when feasible. Many existing and new instruments require validation for use with lower limb amputees.

Out-of-pocket costs and affordability of upper limb prostheses.

BACKGROUND: Given the funding policies in the Department of Veterans Affairs, the affordability of prostheses may be less of a concern among Veterans as compared to civilians. OBJECTIVES: Compare rates of out-of-pocket prosthesis-related payments for Veterans and non-Veterans with upper limb amputation (ULA), develop and validate a measure of prosthesis affordability, and evaluate the impact of affordability on prosthesis nonuse. STUDY DESIGN: Telephone survey of 727 persons with ULA; 76% Veterans and 24% non-Veterans. METHODS: Odds of paying out-of-pocket costs for Veterans compared with non-Veterans were computed using logistic regression. Cognitive and pilot testing resulted in a new scale, evaluated using confirmatory factor and Rasch analysis. Proportions of respondents who cited affordability as a reason for never using or abandoning a prosthesis were calculated. RESULTS: Twenty percent of those who ever used a prosthesis paid out-of-pocket costs. Veterans had 0.20 odds (95% confidence interval, 0.14-0.30) of paying out-of-pocket costs compared with non-Veterans. Confirmatory factor analysis supported unidimensionality of the 4-item Prosthesis Affordability scale. Rasch person reliability was 0.78. Cronbach alpha was 0.87. Overall, 14% of prosthesis never-users said affordability was a reason for nonuse; 9.6% and 16.5% of former prosthesis users said affordability of repairs or replacement, respectively, was a reason for abandonment. CONCLUSIONS: Out-of-pocket prosthesis costs were paid by 20% of those sample, with Veterans less likely to incur costs. The Prosthesis Affordability scale developed in this study was reliable and valid for persons with ULA. Prosthesis affordability was a common reason for never using or abandoning prostheses.

Prosthesis usability experience is associated with extent of upper limb prosthesis adoption: A Structural Equation Modeling (SEM) analysis.

Factors associated with upper limb prosthesis adoption are not well understood. In this study, we explored how prosthesis usability experience relates to the extent of prosthesis adoption through the development of a structural equation model (SEM). First, items related to prosthesis usability were developed and refined using cognitive testing and pilot testing and employed in a survey of 402 prosthesis users (mean age 61.7 (sd 14.4), 77.1% Veterans). The SEM examined two unidimensional latent constructs: Prosthesis Usability Experience and Prosthesis Adoption-and each had multiple measured indicators. SEMs tested direct as well as moderating and mediating effects between the latent constructs and covariates related to demographics and prosthesis type. SEM found a significant positive association between Prosthesis Usability Experience and Extent of Prosthesis Adoption. Several covariates had direct effects on prosthesis adoption: 1) Extent of Prosthesis Adoption was lower for those with transhumeral and shoulder amputation, and higher for those with bilateral amputation, compared to the reference group with unilateral transradial amputation and 2) Myoelectric multiple degree of freedom (multi-DOF) prosthesis use was associated with lower Extent of Prosthesis Adoption, compared to body-powered prosthesis use. Myoelectric multi-DOF use also modified the effect of Prosthesis Usability Experience on Extent of Prosthesis Adoption. For those with bilateral ULA, the strength of the relationship between Prosthesis Usability Experience and Extent of Prosthesis Adoption was reduced. Findings suggest that in order to increase prosthesis adoption, prosthetics developers and rehabilitation providers should focus on implementing strategies to improve prosthesis usability experience. New Prosthesis Usability Experience measures could be used to identify persons at greater risk for poor prosthesis adoption and target interventions to increase prosthesis use.

Emergency Department-Based Physical Function Measures for Falls in Older Adults and Outcomes: A Secondary Analysis of GAPcare.

BACKGROUND AND PURPOSE: Falls are the leading reason for injury-related emergency department (ED) visits for older adults. The Geriatric Acute and Post-acute Fall Prevention Intervention (GAPcare), an in-ED intervention combining a medication therapy management session delivered by a pharmacist and a fall risk assessment and plan by a physical therapist, reduced ED revisits at 6 months among older adults presenting after a fall. Our objective was to evaluate the relationship between measures of function obtained in the ED and clinical outcomes. METHODS: This was a secondary analysis of data from GAPcare, a randomized controlled trial conducted from January 2018 to October 2019 at 2 urban academic EDs. Standardized measures of function (Timed Up and Go [TUG] test, Barthel Activity of Daily Living [ADL], Activity Measure for Post Acute Care [AM-PAC] 6 clicks) were collected at the ED index visit. We performed a descriptive analysis and hypothesis testing (chi square test and analysis of variance) to assess the relationship of functional measures with outcomes (ED disposition, ED revisits for falls, and place of residence at 6 months). Emergency department disposition status refers to discharge location immediately after the ED evaluation is complete (eg, hospital admission, original residence, skilled nursing facility). RESULTS AND DISCUSSION: Among 110 participants, 55 were randomized to the GAPcare intervention and 55 received usual care. Of those randomized to the intervention, 46 received physical therapy consultation. Median age was 81 years; participants were predominantly women (67%) and White (94%). Seventy-three (66%) were discharged to their original residence, 14 (13%) were discharged to a skilled nursing facility and 22 (20%) were admitted. There was no difference in ED disposition status by index visit Barthel ADLs (P = .371); however, TUG times were faster (P = .016), and AM-PAC 6 clicks score was higher among participants discharged to their original residence (P ≤ .001). Participants with slower TUG times at the index ED visit were more likely to reside in nursing homes by six months (P = .002), while Barthel ADL and AM-PAC 6 clicks did not differ between those residing at home and other settings. CONCLUSIONS: Measures of function collected at the index ED visit, such as the AM-PAC 6 clicks and TUG time, may be helpful at predicting clinical outcomes for older adults presenting for a fall. Based on our study findings, we suggest a novel workflow to guide the use of these clinical measures for ED patients with falls.

Assessment of Patient-Reported Physical Function in Persons With Upper Extremity Amputation: Comparison of Short Form Instruments.

OBJECTIVE: The aim of the study was to compare psychometric properties of the Patient-Reported Outcomes Measurement Information System upper extremity measure (PROMIS UE) 7-item short form with 6- and 13-item versions for persons with upper limb amputation. DESIGN: The study used a telephone survey of 681 persons with upper limb amputation. Versions were scored two ways: PROMIS health measure scoring (PROMIS UE HMSS) and sample-specific calibration (PROMIS UE AMP). Factor analyses and Rasch analyses evaluated unidimensionality, monotonicity, item fit, differential item functioning, and reliability. Known group validity was compared for all versions. RESULTS: Model fit was acceptable for PROMIS-6 UE AMP and marginally acceptable for PROMIS-13 UE AMP and PROMIS-7 UE AMP. Item response categories were collapsed because of disordered categories. A total of 91.4% of participants had PROMIS-13 UE AMP scores with reliability greater than 0.8, compared with 70.4% for PROMIS-7 UE AMP, and 72.1% for PROMIS-6 UE AMP versions. No differences were observed by prosthesis use. Scores differed by amputation for all measures except the HMSS scored 13- and 7-item versions. CONCLUSIONS: The PROMIS-13 UE AMP short form was superior to the health measures scoring system scored PROMIS-7 UE or PROMIS-6 UE, and to the PROMIS-7 UE AMP and PROMIS-6 UE AMP. Issues with known group validation suggest a need for a population-specific measure of upper extremity function for persons with upper limb amputation.

Increased Medicare Advantage Penetration Is Associated With Lower Postacute Care Use For Traditional Medicare Patients.

Medicare Advantage (MA) plans, which accounted for 45 percent of total Medicare enrollment in 2022, are incentivized to minimize spending on low-value services. Prior research indicates that MA plan enrollment is associated with reduced postacute care use without adverse impacts on patient outcomes. However, it is unclear whether a rising MA enrollment level is associated with a change in postacute care use in traditional Medicare, especially given growing participation in traditional Medicare Alternative Payment Models that have been found to be associated with lower postacute care spending. We hypothesize that market-level MA expansion is associated with reduced postacute care use among traditional Medicare beneficiaries-a "spillover" effect of providers modifying their practice patterns in response to MA plans' incentives. We found increased MA market penetration associated with reduced postacute care use among traditional Medicare beneficiaries, without a corresponding increase in hospital readmissions. This association was generally stronger in markets with a greater share of traditional Medicare beneficiaries attributed to accountable care organizations, suggesting that policy makers should account for MA penetration when evaluating potential savings in Alternative Payment Models within traditional Medicare.

Patterns of Limitation in Physical Function in Late Midlife Associated with Late-Onset Alzheimer's Disease and Related Dementias: A Cluster Analysis.

BACKGROUND: To reduce the increasing societal and financial burden of Alzheimer's disease and related dementias (ADRD), prevention is critical. Even small improvements of the modifiable dementia risk factors on the individual level have the potential to lead to a substantial reduction of dementia cases at the population level. OBJECTIVE: To determine if pattern(s) of functional decline in midlife associate with late-onset ADRD years later. METHODS: Using a longitudinal study of adults aged 51-59 years in 1998 without symptoms of ADRD by 2002 and followed them from 2002 to 2016 (n = 5404). The outcome was incident ADRD identified by the Lange-Weir algorithm, death, or alive with no ADRD. We used cluster analysis to identify patterns of functional impairment at baseline and multinomial regression to assess their association with future ADRD. RESULTS: Three groups of adults with differing patterns of functional impairment were at greater risk of future ADRD. Difficulty with climbing one flight of stairs was observed in all adults in two of these groups. In the third group, 100% had difficulty with lifting 10 pounds and pushing or pulling a large object, but only one-fourth had difficulty in climbing stairs. CONCLUSION: Results imply that improved large muscle strength could decrease future risk of ADRD. If confirmed in other studies, screening for four self-reported measures of function among adults in midlife may be used for targeted interventions.

Is Telerehabilitation a Viable Option for People With Low Back Pain? Associations Between Telerehabilitation and Outcomes During the COVID-19 Pandemic.

OBJECTIVE: The aims of this study were to examine associations between frequency of telerehabilitation (TR) and outcomes of functional status (FS), number of visits, and patient satisfaction during COVID-19 and to compare FS outcomes by TR delivery mode for individuals with low back pain. METHODS: Propensity score matching was used to match episodes of care with or without TR exposure by the probability of receiving TR. FS, visits, and satisfaction were compared for individuals without TR and those who received care by TR for "any," "few," "most," or "all" frequencies (4 matched samples), and FS was compared for individuals receiving synchronous, asynchronous, and mixed TR modes (3 matched samples). Standardized differences were used to compare samples before and after matching. Outcomes between matched samples were compared using z tests with 95% CI. RESULTS: The sample consisted of 91,117 episodes of care from 1398 clinics located in 46 states (58% women; mean age = 55 [SD = 18]). Of those, only 5013 episodes (5.5%) involved any amount of TR. All standardized differences between matched samples were <0.1. There was no significant difference in FS points (range = 0-100, with higher representing better FS) between matched samples, except for episodes that had ``few'' (-1.7) and ``all'' (+2.0) TR frequencies or that involved the asynchronous (-2.6) TR mode. These point differences suggest limited clinical importance. Episodes with any TR frequency involved significantly fewer visits (0.7-1.3) than episodes with no TR, except that those with the "most" TR frequency had non-significantly fewer visits (0.6). A smaller proportion of individuals with TR (-4.0% to -5.0%) than of individuals with no telerehabilitation reported being very satisfied with treatment results, except for those with the "all" TR frequency. CONCLUSIONS: A positive association between TR and rehabilitation outcomes was observed, with a trend for better FS outcomes and fewer visits when all care was delivered through TR. Satisfaction tended to be lower with TR use. Overall, this observational study showed that for people with low back pain, physical therapy delivered through TR was equally effective as and more efficient than in-person care, with a trend of higher effectiveness when used for all visits during the episode of care. No differences in FS outcomes were observed between care delivered with synchronous and mixed TR delivery modes and care delivered with no TR. However, the asynchronous mode of TR was associated with worse functional outcomes than no TR. Although the majority of people were very satisfied with their treatment results with and without TR, very high satisfaction rates were reported by a slightly smaller proportion of individuals with TR versus those without TR. Our results suggest that TR is a viable option for rehabilitation care for individuals with low back pain and should also be considered in the post-COVID-19 era.

Telephone and face to face methods of assessment of veteran's community reintegration yield equivalent results.

BACKGROUND: The Community Reintegration of Service Members (CRIS) is a new measure of community reintegration developed to measure veteran's participation in life roles. It consists of three sub-scales: Extent of Participation (Extent), Perceived Limitations with Participation (Perceived), and Satisfaction with Participation (Satisfaction). Testing of the CRIS measure to date has utilized in-person administration. Administration of the CRIS measure by telephone, if equivalent to in-person administration, would be desirable to lower cost and decrease administrative burden. The purpose of this study was to test the equivalence of telephone and in-person mode of CRIS administration. METHODS: A convenience sample of 102 subjects (76% male, 24% female, age mean = 49 years, standard deviation = 8.3) were randomly assigned to received either telephone interview at Visit 1 and in-person interview at Visit 2, or in-person interview at Visit 1 and telephone interview a Visit 2. Both Visits were conducted within one week. Intraclass correlation coefficients, ICC (2,1), were used to evaluate correspondence between modes for both item scores and summary scores. ANOVAs with mode order as a covariate were used to test for presence of an ordering effect. RESULTS: ICCs (95%CI) for the subscales were 0.92 (0.88-0.94) for Extent, 0.85 (0.80-0.90) for Perceived, and 0.89 (0.84-0.93) for Satisfaction. No ordering effect was observed. CONCLUSION: Telephone administration of the CRIS measure yielded equivalent results to in-person administration. Telephone administration of the CRIS may enable lower costs of administration and greater adoption.

Medicare's New Patient Driven Payment Model Resulted In Reductions In Therapy Staffing In Skilled Nursing Facilities.

Medicare's Patient Driven Payment Model (PDPM) significantly altered the way skilled nursing facilities (SNFs) are paid, removing the financial incentive to maximize the volume of therapy services delivered to patients. Using federal payroll-based staffing data, we examined the effect of the PDPM on SNF therapy and nursing staff hours. After PDPM implementation, which took effect October 1, 2019, SNFs significantly reduced their therapy staff hours. Physical therapist and occupational therapist staffing levels were reduced by 5-6 percent during October-December 2019 relative to pre-PDPM levels, and physical therapy assistant and occupational therapist assistant levels were reduced by about 10 percent. These reductions were concentrated among contracted employees and were larger in SNFs with higher shares of Medicare-eligible short-stay residents. No meaningful increases in nursing staff in response to the PDPM were found. Further research is needed to determine the effect of these therapy staff reductions on SNF patient outcomes.

Structural validity and reliability of the patient experience measure: A new approach to assessing psychosocial experience of upper limb prosthesis users.

Recent advances in upper limb prosthetics include sensory restoration techniques and osseointegration technology that introduce additional risks, higher costs, and longer periods of rehabilitation. To inform regulatory and clinical decision making, validated patient reported outcome measures are required to understand the relative benefits of these interventions. The Patient Experience Measure (PEM) was developed to quantify psychosocial outcomes for research studies on sensory-enabled upper limb prostheses. While the PEM was responsive to changes in prosthesis experience in prior studies, its psychometric properties had not been assessed. Here, the PEM was examined for structural validity and reliability across a large sample of people with upper limb loss (n = 677). The PEM was modified and tested in three phases: initial refinement and cognitive testing, pilot testing, and field testing. Exploratory factor analysis (EFA) was used to discover the underlying factor structure of the PEM items and confirmatory factor analysis (CFA) verified the structure. Rasch partial credit modeling evaluated monotonicity, fit, and magnitude of differential item functioning by age, sex, and prosthesis use for all scales. EFA resulted in a seven-factor solution that was reduced to the following six scales after CFA: social interaction, self-efficacy, embodiment, intuitiveness, wellbeing, and self-consciousness. After removal of two items during Rasch analyses, the overall model fit was acceptable (CFI = 0.973, TLI = 0.979, RMSEA = 0.038). The social interaction, self-efficacy and embodiment scales had strong person reliability (0.81, 0.80 and 0.77), Cronbach's alpha (0.90, 0.80 and 0.71), and intraclass correlation coefficients (0.82, 0.85 and 0.74), respectively. The large sample size and use of contemporary measurement methods enabled identification of unidimensional constructs, differential item functioning by participant characteristics, and the rank ordering of the difficulty of each item in the scales. The PEM enables quantification of critical psychosocial impacts of advanced prosthetic technologies and provides a rigorous foundation for future studies of clinical and prosthetic interventions.

A National Survey of Prosthesis Use in Veterans with Major Upper Limb Amputation: Comparisons by Gender.

BACKGROUND: A better understanding of women veterans with upper limb amputation is needed. OBJECTIVE: To compare prosthetic use and outcomes of female and male veterans with upper limb amputation. DESIGN: Cross-sectional survey: Amputation characteristics, prosthesis use, and quality of life outcomes were compared by gender. Separate logistic regression models examined association of gender with prosthesis use and receipt of training to use a prosthesis. Separate linear regression models examined the relationship between gender and health-related quality of life (HRQoL) outcomes. PARTICIPANTS: Participants were veterans with major upper limb amputation who received care at the Department of Veterans Affairs (VA) in 2010-2015, identified from VA data sources. A total of 808 individuals (755 men, 21 women) were surveyed by telephone. MAIN OUTCOME MEASURES: Disabilities of the Arm, Shoulder and Hand (QuickDASH), VR-12 Physical Component Summary (PCS) and VR-12 Mental Component Summary (MCS), Trinity Amputation and Prosthetic Experience Scale satisfaction scale, Orthotics and Prosthetic User's Survey client satisfaction with devices scale. SETTING: Telephone survey of community dwelling participants. INTERVENTIONS: Not applicable. RESULTS: Survey response rate was 47.3% for men and 62.8% for women. Women were less likely to have ever used a prosthesis (adjusted odds ratio [aOR] = 0.26; confidence interval [CI] 0.08-0.88), have received training for an initial prosthesis (aOR: 0.24; CI 0.08-0.70), be current users (aOR = 0.34; CI 0.12-1.01), and have received training for a current prosthesis (aOR: 0.15; 0.03-0.87). A greater proportion of women used cosmetic and a smaller proportion used body-powered devices compared to men (P < .05). Device heaviness or fatigue was the most common reason for abandonment. There were no significant differences in outcome measures by gender. CONCLUSIONS: Women were less likely than men to have ever used and currently use prostheses or to have received prosthetic training, more likely to use cosmetic devices, and less likely to use body-powered devices. Efforts to develop prostheses that are cosmetically acceptable, yet lightweight and functional, are needed.

The benefits of sensation on the experience of a hand: A qualitative case series.

BACKGROUND: The experience of upper limb loss involves loss of both functional capabilities and the sensory connection of a hand. Research studies to restore sensation to persons with upper limb loss with neural interfaces typically measure outcomes through standardized functional tests or quantitative surveys. However, these types of metrics cannot fully capture the personal experience of living with limb loss or the impact of sensory restoration on this experience. Qualitative studies can demonstrate the viewpoints and priorities of specific persons or groups and reveal the underlying conceptual structure of various aspects of their experiences. METHODS AND FINDINGS: Following a home use trial of a neural-connected, sensory-enabled prosthesis, two persons with upper limb loss were interviewed about their experiences using the sensory restoration system in unsupervised, unconstrained settings. We used grounded theory methodology to examine their experiences, perspectives, and opinions about the sensory restoration system. We then developed a model to describe the impact of sensation on the experience of a hand for persons with upper limb loss. CONCLUSIONS: The experience of sensation was complex and included concepts such as the naturalness of the experience, sensation modality, and the usefulness of the sensory information. Sensation was critical for outcome acceptance, and contributed to prosthesis embodiment, confidence, reduced focus and attention for using the prosthesis, and social interactions. Embodiment, confidence, and social interactions were also key determinants of outcome acceptance. This model provides a unified framework to study and understand the impact of sensation on the experience of limb loss and to understand outcome acceptance following upper limb loss more broadly.

Learning of Artificial Sensation Through Long-Term Home Use of a Sensory-Enabled Prosthesis.

Upper limb prostheses are specialized tools, and skilled operation is learned by amputees over time. Recently, neural prostheses using implanted peripheral nerve interfaces have enabled advances in artificial somatosensory feedback that can improve prosthesis outcomes. However, the effect of sensory learning on artificial somatosensation has not been studied, despite its known influence on intact somatosensation and analogous neuroprostheses. Sensory learning involves changes in the perception and interpretation of sensory feedback and may further influence functional and psychosocial outcomes. In this mixed methods case study, we examined how passive learning over 115 days of home use of a neural-connected, sensory-enabled prosthetic hand influenced perception of artificial sensory feedback in a participant with transradial amputation. We examined perceptual changes both within individual days of use and across the duration of the study. At both time scales, the reported percept locations became significantly more aligned with prosthesis sensor locations, and the phantom limb became significantly more extended toward the prosthesis position. Similarly, the participant's ratings of intensity, naturalness, and contact touch significantly increased, while his ratings of vibration and movement significantly decreased across-days for tactile channels. These sensory changes likely resulted from engagement of cortical plasticity mechanisms as the participant learned to use the artificial sensory feedback. We also assessed psychosocial and functional outcomes through surveys and interviews, and found that self-efficacy, perceived function, prosthesis embodiment, social touch, body image, and prosthesis efficiency improved significantly. These outcomes typically improved within the first month of home use, demonstrating rapid benefits of artificial sensation. Participant interviews indicated that the naturalness of the experience and engagement with the prosthesis increased throughout the study, suggesting that artificial somatosensation may decrease prosthesis abandonment. Our data showed that prosthesis embodiment was intricately related to naturalness and phantom limb perception, and that learning the artificial sensation may have modified the body schema. As another indicator of successfully learning to use artificial sensation, the participant reported the emergence of stereognosis later in the study. This study provides the first evidence that artificial somatosensation can undergo similar learning processes as intact sensation and highlights the importance of sensory restoration in prostheses.

User experience of controlling the DEKA Arm with EMG pattern recognition.

INTRODUCTION: A commercially available EMG Pattern Recognition (EMG-PR) control system was adapted to interface with the multi-degree of freedom (DOF) DEKA Arm. PURPOSE: To describe users' experience of controlling the DEKA Arm using EMG-PR. METHODS: Sample: Twelve persons with upper limb amputation participated, 10 with transradial (TR), 2 with transhumeral (TH) level amputation. Ten were male, and 11 were users of a prosthesis at baselines. Design: This was a two-part study consisting of in-laboratory prosthetic training (Part A) and up to 12 weeks of home use of the prosthesis (Part B). Data collection: Qualitative data were collected through open-ended survey questions and semi-structured interviews. Data Analysis: The study used a qualitative case series design with a constant comparative approach to identify common categories of experience. Coding categories were iteratively refined until saturation of categories was achieved. The data were organized in a primary category, major categories of experience, factors impacting experience, and broader contextual factors. RESULTS: Users had mixed perspectives on the desirability of the EMG-PR control system in combination with the DEKA Arm. Major aspects of user experience related to the system complexity, process of calibrating, and functional benefits. Factors influencing user experience included training and acclimation, fatigue, prosthesis design, technical issues and control changes. Broader contextual factors, both personal and environmental, also impacted users' experience. DISCUSSION/CONCLUSION: This study provided an in-depth description of user experience operating the DEKA Arm using EMG-PR control. The majority of participants expressed a preference for the controls of their personal prosthesis and controls rather than the iteration of EMG-PR controlled DEKA Arm used in this study. Most were positive about the future potential of EMG-PR as a control method. An understanding of patient experience will assist clinicians and patients choosing prosthetic options.

EMG pattern recognition compared to foot control of the DEKA Arm.

INTRODUCTION: EMG pattern recognition control (EMG-PR) is a promising option for control of upper limb prostheses with multiple degrees of freedom (DOF). The purposes of this study were to 1) evaluate outcomes of EMG-PR and inertial measurement units (IMU) control of the DEKA Arm as compared to personal prosthesis; and 2) compare outcomes of EMG-PR to IMU control of DEKA Arm. METHODS: This was a quasi-experimental, multi-site study with repeated measures that compared non-randomized groups using two types of controls: EMG-PR and IMUs. Subjects (N = 36) were transradial (TR) and transhumeral (TH) amputees. Outcomes were collected at Baseline (using personal prosthesis), and after in-laboratory training (Part A), and home use (Part B). Data was compared to personal prosthesis, stratified by amputation level and control type. Outcomes were also compared by control type. RESULTS: The EMG-PR group had greater prosthesis use after Part A, but worse dexterity, lower satisfaction, and slower activity performance compared to Baseline; the IMU group had slower activity performance. After Part B, the EMG-PR group had less perceived activity difficulty; the IMU group had improved activity performance, improved disability and activity difficulty, but slower performance. No differences were observed for TH group by control type in Part A or B. The TR group using EMG-PR had worse dexterity (Parts A & B), and activity performance (Part A) as compared to IMU users. DISCUSSION/CONCLUSION: Findings suggest that for the TR group that IMUs are a more effective control method for the DEKA Arm as compared to the EMG-PR prototypes employed in this study. Further research is needed to refine the EMG-PR systems for multi-DOF devices. Future studies should include a larger sample of TH amputees. TRIAL REGISTRATION: ClinicalTrials.gov NCT01551420.

How do the outcomes of the DEKA Arm compare to conventional prostheses?

OBJECTIVES: Objectives were to 1) compare self-reported function, dexterity, activity performance, quality of life and community integration of the DEKA Arm to conventional prostheses; and 2) examine differences in outcomes by conventional prosthesis type, terminal device type and by DEKA Arm configuration level. METHODS: This was a two-part study; Part A consisted of in-laboratory training. Part B consisted of home use. Study participants were 23 prosthesis users (mean age = 45 ± 16; 87% male) who completed Part A, and 15 (mean age = 45 ± 18; 87% male) who completed Parts A and B. Outcomes including self-report and performance measures, were collected at Baseline using participants' personal prostheses and at the End of Parts A and B. Scores were compared using paired t-tests. Wilcoxon signed-rank tests were used to compare outcomes for the full sample, and for the sample stratified by device and terminal device type. Analysis of outcomes by configuration level was performed graphically. RESULTS: At the End of Part A activity performance using the DEKA Arm and conventional prosthesis was equivalent, but slower with the DEKA Arm. After Part B, performance using the DEKA Arm surpassed conventional prosthesis scores, and speed of activity completion was equivalent. Participants reported using the DEKA Arm to perform more activities, had less perceived disability, and less difficulty in activities at the End of A and B as compared to Baseline. No differences were observed in dexterity, prosthetic skill, spontaneity, pain, community integration or quality of life. Comparisons stratified by device type revealed similar patterns. Graphic comparisons revealed variations by configuration level. CONCLUSION: Participants using the DEKA Arm had less perceived disability and more engagement of the prosthesis in everyday tasks, although activity performance was slower. After home use experience, activity performance was improved and activity speed equivalent to using conventional prostheses.