Use of Standardized Outcome Measures for People With Lower Limb Amputation: A Survey of Prosthetic Practitioners in the United States.

OBJECTIVE: To assess the clinical resources available for the assessment of health outcomes in people with lower limb amputation and to understand barriers and facilitators associated with use of standardized outcome measures in clinical practice. DESIGN: Cross-sectional survey. SETTING: General community (online). PARTICIPANTS: A volunteer sample of prosthetic practitioners was recruited through national professional organizations. Eligible participants were practitioners certified by a professional prosthetics organization and currently practicing as a prosthetist, prosthetist-orthotist, or prosthetic assistant. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A custom-designed online survey on clinical use of patient-reported and performance-based standardized outcome measures to assess patients with lower limb amputation. RESULTS: A total of 375 participants completed the survey. Most participants (79%) reported that they are encouraged or required to administer standardized outcome measures in their clinic or facility. Most participants reported that use of patient-reported and performance-based outcome measures are within their scope of practice (88%) and that they have the knowledge required for outcomes measurement (84%). Few participants agreed that outcomes measurement is standardized across the profession (30%). Most participants had access to small spaces and equipment for outcomes measurement, such as short hallways (65%-94%), stairs (69%), and tablets with wireless internet connection (83%). Most participants reported that they would be willing to spend between 5 (36% of participants) and 10 (43% of participants) minutes on self-reported surveys, and between 10 (41% of participants) and 20 (28% of participants) minutes on performance-based tests. CONCLUSIONS: Outcomes measurement is encouraged or expected in contemporary prosthetic practice. Strategies to improve standardization and efficiency of administration are needed to facilitate routine use of outcome measures in clinical care.

A Comparison of the Two-Minute Walk Test (2MWT) and Comprehensive High-level Activity Mobility Predictor (CHAMP) in People with a Leg Prosthesis.

OBJECTIVE: To determine if the two-minute walk test (2MWT) could serve as an alternative measure of high-level mobility in lower limb prosthesis users when circumstances preclude administration of the Comprehensive High-level Activity Mobility Predictor (CHAMP). DESIGN: Cross-sectional study. SETTING: Indoor recreational athletic field and gymnasium. SUBJECTS: Fifty-eight adult lower limb prosthesis users with unilateral or bilateral lower limb amputation who participate in recreational athletic activities. INTERVENTION: N/A. MAIN MEASURES: The 2MWT and CHAMP while using their preferred prosthesis(es) on an indoor artificial athletic field or hardwood gymnasium floor. RESULTS: Thirty-nine men and nineteen women with a median age of 38.3 years participated in the study. Most participants experienced amputation(s) due to trauma (62%) or tumor (10%) and were generally higher functioning (K4 (91.4%) and K3 (8.6%)). The median (range) score for the CHAMP was 23.0 points (1.5-33.5) and the mean ± standard deviation (range) 2MWT distance walked was 188.6 ± 33.9 m (100.2-254.3 m). The CHAMP demonstrated a strong positive relationship with 2MWT (r = 0.83, p < 0.001). The 2MWT distance predicted 70% of the variance in CHAMP score. CONCLUSIONS: Although the 2MWT does not test multi-directional agility like the CHAMP, they were found to be highly correlated. If space is limited, the two-minute walk test can serve as an alternative measure for assessing high-level mobility capabilities in lower limb prosthesis users.

Clinical Resources for Assessing Mobility of People with Lower-Limb Amputation: Interviews with Rehabilitation Clinicians.

Introduction: Mobility tests are increasingly used in prosthetic rehabilitation to evaluate patient outcomes. Knowledge of the space, equipment, and time resources available to clinicians who work in different settings can guide recommendations for which tests are most clinically-feasible and promote coordination of mobility testing among members of the rehabilitation team. The primary aim of this study was to characterize the different resources available to clinicians for measuring mobility of people with lower limb amputation. A secondary aim was to identify performance tasks that clinicians use to evaluate prosthetic mobility. Materials and methods: Semi-structured interviews were conducted with prosthetists, physical therapists, and physiatrists who treat people with lower limb amputation. Researchers used convenience and snowball sampling to identify participants. Interviews included questions about the resources available for conducting mobility tests, as well as questions about which tasks clinicians deemed valuable to assessing mobility of patients with lower limb amputation. Interviews were audio-recorded and transcribed. Summary and frequency statistics were calculated for quantitative data; explanatory comments were summarized. Results: Interviews were conducted with 25 clinicians (8 prosthetists, 9 physical therapists, and 8 physiatrists). Participants had access to multiple spaces and basic measurement equipment. The maximum time participants were willing to spend on performance tests varied. Physiatrists reported less time available (median=10 minutes, range 5-30 minutes) than prosthetists and physical therapists (median=30 minutes, range 5-60 minutes for both professions). Mobility tasks commonly used to evaluate patients with lower limb amputation included sit-to-stand, standing balance, walking, and varying speed. Participant comments suggested that mobility tests need to be quick, simple, and add value; existing mobility tests are beneficial but challenging to incorporate into practice; mobility tests should reflect real-world activities; and technological advancements could improve mobility testing. Conclusions: Clinicians generally had small-to-medium spaces, basic measurement equipment, and sufficient training to administer mobility tests in their clinics. A limiting factor was time, which can be addressed through selection of efficient measures and collaboration within the rehabilitation team.

Prosthetists' perceptions of information obtained from a lower limb prosthesis monitoring system: a pilot study.

INTRODUCTION: Prosthetists have limited knowledge of their patients' use of a prosthesis outside of the clinical environment. Prosthesis-mounted monitors can be used to directly measure patients' prosthesis use and activity. Prosthetists' opinions regarding potential clinical applications for sensor-based information may inform further development of this technology. A pilot study was conducted to assess prosthetists' perceptions of prosthesis use and activity information obtained by a monitoring system. MATERIALS AND METHODS: Three local prosthetists were recruited to participate in the study. One patient with transtibial amputation from each prosthetist volunteered to wear limb presence and activity monitors for two weeks. Collected data were used to determine prosthesis use and activity. Each prosthetist completed a survey, examined clinical reports of their patient's prosthesis use and activity, and participated in a semi-structured interview. Survey results and interview transcripts were analyzed to identify and compare prosthetists' perceptions. RESULTS: Prosthesis use and activity varied among patients. Prosthetists over- and under-estimated patient activity, relative to measurements recorded by the monitors. All three prosthetists selected multiple clinical applications for the prosthesis use and activity information in the survey, and several additional applications were suggested during the interviews. When presented with multiple report formats, prosthetists found features of each to be clinically useful. CONCLUSIONS: Prosthesis-mounted monitors may provide prosthetists with a better understanding of their patients' prosthesis use and activity. Information provided by the monitoring system may inform clinical decisions and promote evidence-based practices.

Development of a candidate item bank for measuring mobility of lower limb orthosis users.

BACKGROUND: Orthoses are often prescribed to improve mobility of people with chronic health conditions that affect lower limb function. Patient-reported survey instruments can be used to measure aspects of mobility that cannot be easily assessed in clinical or research settings. A population-specific item bank could be designed to measure aspects of mobility that are most important to lower limb orthosis users and used to evaluate the effects of orthoses. OBJECTIVE: To develop items for a new survey instrument to measure mobility of lower limb orthosis users. DESIGN: Survey items were developed using a qualitative item review process. SETTING: Focus groups were held by video conferencing. Cognitive interviews were conducted by telephone. PARTICIPANTS: Focus group and cognitive interview participants were adults with at least 6 months of experience using a lower limb orthosis that extended from the foot to a level above the ankle. METHODS: Research methods included focus groups with lower limb orthosis users, an item generation and reduction process that involved a stakeholder advisory panel, and cognitive interviews with target respondents. RESULTS: A total of 1180 extant items were identified in a literature review. Focus group participants (n = 29) provided feedback that informed the suitability of a construct definition and conceptual model. An advisory panel contributed to the selection of 118 candidate items for measuring orthotic mobility. Feedback from cognitive interview participants (n = 30) informed removal or revision of problematic items, resulting in a candidate bank of 100 mobility items. CONCLUSIONS: The rigorous qualitative methods applied here resulted in a large set of candidate items that spanned a range of situations relevant to moving with a lower limb orthosis. Next steps include administration of the candidate items to a large sample of lower limb orthosis users and calibration of the item bank.

Modifying the five-time sit-to-stand test to allow use of the upper limbs: Assessing initial evidence of construct validity among lower limb prosthesis users.

The Five-time Sit-to-Stand (5xSTS) Test is a performance-based measure used by clinicians and researchers to assess the body functions needed to accomplish sit-to-stand transitions (e.g., lower limb strength, balance, and trunk control). The current requirements for performance of the 5xSTS Test (i.e., crossing arms over the chest) may not be appropriate for many, if not most lower limb prosthesis (LLP) users. The study aims were to (1) develop a modified five-time sit-to-stand (m5xSTS) Test protocol; (2) to examine initial evidence of known-groups construct validity among LLP users by comparing differences in performance by amputation level, amputation etiology, and functional level; and (3) to assess initial evidence of convergent construct validity by examining the correlations between m5xSTS performance with self-reported mobility (Prosthetic Limb Users Survey of Mobility (PLUS-M)), self-reported balance confidence (Activities-balance Confidence Scale (ABC)) and functional capability (comfortable walking speed). Three-hundred sixty-one LLP users participated in this cross-sectional study. The investigators developed a m5xSTS Test protocol that allows tested individuals to use different assistance strategies (i.e., use of upper limbs to push off thighs, push up from the armrests, or use a walker) when needed to perform the test. The investigators recorded m5xSTS Test times and assistance strategies. Significant differences in m5xSTS Test times were found between those who did and did not use an assistance strategy, as well as between participants grouped by different amputation level, etiology, and functional level. Significant moderate negative correlations were found between m5xSTS Test times and PLUS-M T-score (ρ = -0.42, p<0.001), ABC score (ρ = -0.42, p<0.001), and comfortable walking speed (ρ = -0.64, p<0.001), respectively. The m5xSTS Test allows LLP users to perform sit-to-stand transitions in a manner that accounts for their functional impairments, is consistent with post-amputation training, and is safe for the tested individual. Results from this study provide preliminary evidence of known groups and convergent construct validity for the m5xSTS Test with a large national sample of LLP users.

Development and initial validation of the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M): An item bank for evaluating mobility of people who use lower-limb orthoses.

Lower limb orthoses (LLOs) are externally-applied leg braces that are designed to improve or maintain mobility in people with a variety of health conditions that affect lower limb function. Clinicians and researchers are therefore often motivated to measure LLO users' mobility to select or assess the effectiveness of these devices. Patient-reported outcome measures (PROMs) can provide insights into important aspects of a LLO user's mobility for these purposes. However, few PROMs are available to measure mobility of LLO users. Those few that exist have issues that may limit their clinical or scientific utility. The objective of this study was to create a population-specific item bank for measuring mobility of LLO users. Previously-developed candidate items were administered in a cross-sectional study to a large national sample of LLO users. Responses from study participants (n = 1036) were calibrated to a graded response statistical model using Item Response Theory methods. A set of 39 items was found to be unidimensional, locally independent, and function without bias due to characteristics unrelated to mobility. The set of final calibrated items, termed the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M) item bank, was evaluated for initial evidence of convergent, divergent, and known groups construct validity. OPRO-M was strongly correlated with existing PROMs designed to measure aspects of physical function. Conversely, OPRO-M was weakly correlated with PROMs that measured unrelated constructs, like sleep disturbance and depression. OPRO-M also showed an ability to differentiate groups with expected mobility differences. Two fixed-length short forms were created from the OPRO-M item bank. Items on the short forms were selected based on statistical and clinical criteria. Collectively, results from this study indicate that OPRO-M can effectively measure mobility of LLO users, and OPRO-M short forms can now be recommended for use in routine clinical practice and research studies.

Japanese translation and linguistic validation of the Prosthetic Limb Users Survey of Mobility (PLUS-M).

BACKGROUND: Self-report survey instruments can be used to improve clinical care for lower-limb prosthesis users on a global scale by pooling comparable health outcomes data from multiple countries. The language translation process is critical to the quality and comparability of a translated survey instrument. OBJECTIVES: The goals of this research were to translate the Prosthetic Limb Users Survey of Mobility (PLUS-M) item bank from English to Japanese using established guidelines, and linguistically validate the translated instrument by assessing its clarity, comprehension, and cultural applicability with Japanese prosthesis users. STUDY DESIGN: Instrument translation and qualitative interviews. METHODS: The translation process included two forward translations, reconciliation, backward translation, and review by clinical experts in Japan. Adult lower-limb prosthesis users participated in a linguistic validation study by responding to translated survey items and providing item-by-item feedback through cognitive interviews. RESULTS: Following expert reviews, translated items were classified as grammatically and contextually unchanged (n = 21), minor revision required (n = 19), major revision required (n = 3), or removed (n = 1). Cognitive interviews with 10 participants indicated that additional revisions were required (n = 4). Items were revised and retested until it was determined that they were clear, well understood, and culturally applicable. CONCLUSIONS: Use of a multistep translation and linguistic validation processes resulted in a linguistically comparable Japanese translation of the PLUS-M item bank. Japanese translations of the PLUS-M 7- and 12-item short forms were created for use in clinical practice and research. Availability of these linguistically comparable instruments is expected to facilitate opportunities for international comparison of prosthetic mobility data.

Mobility experiences of adult lower limb orthosis users: a focus group study.

PURPOSE: People with lower limb impairments are often prescribed orthoses to preserve or enhance their mobility. Exploration of mobility experiences common among orthosis users may provide insights into how orthoses, and other mobility aids, are utilized and regarded. The objective of this study was to broadly explore how lower limb orthosis users describe their mobility. MATERIALS AND METHODS: Four focus groups were held online with participants who lived in the U.S. or Canada. Participants had at least six months of experience using an ankle-foot- and/or a knee-ankle-foot-orthosis for one or both legs. All discussions were transcribed and coded. Thematic analysis was used to identify cross-cutting themes. RESULTS: Participants included 29 orthosis users with a variety of health conditions. Inter-related themes, including personal factors, situational contexts, and assistance were identified as elements that influenced participants' mobility. Participants described a process of modifying their mobility through the use and non-use of one or more mobility aids. CONCLUSIONS: The current study findings may assist clinicians in developing strategies to optimize orthosis users' mobility in different situations. Experiences described by participants in this study may also help researchers identify aspects of mobility most pertinent to orthosis users and inform the development of new outcome measures.Implications for RehabilitationPeople who use lower-limb orthoses share common mobility experiences, despite differences in health diagnoses.Orthosis users often have opportunities to modify their mobility by choosing to use or not use their brace(s) and/or handheld mobility aids.When providing mobility aid interventions, clinicians should consider how each patient's individual characteristics, including physical characteristics (e.g., the health condition and how it presents, pain, fatigue) and psychosocial characteristics (e.g., fear and confidence, self-motivation, emotional responses), can affect mobility.Clinicians may be able to help patients optimize their mobility by asking about environmental obstacles they regularly encounter and recommending strategies for utilization of mobility aids, including simultaneous use of multiple aids, use of one aid, or choosing not to use any aids, depending on the activity and situation.Clinicians should inquire about all mobility aids available to a patient at home and in the community, including fixed objects, and consider how new mobility aid interventions might affect the patient's mobility when used alone and in combination with other forms of assistance.