The development and reliability testing of the Functional Lower-Limb Amputee Gait Assessment.

OBJECTIVE: The study purpose was three-fold: (a) to describe the development of the Functional Lower-Limb Amputee Gait Assessment, (b) to determine its reliability with two groups of raters, physical therapists, and certified prosthetists, and (c) to determine the agreement on its results between the two groups. DESIGN: A reliability study. SETTING: Institution for higher education. PARTICIPANTS: Five physical therapists and five certified prosthetists. INTERVENTION: Not applicable. MAIN MEASURE: The gait of people with unilateral lower limb amputation was evaluated using the Functional Lower-Limb Amputee Gait Assessment. Kappa statistic was used to analyze reliability. RESULTS: The intra-rater reliability of nine gait deviations in the physical therapists' group and eight in the certified prosthetists' group was between moderate and almost perfect agreement (kappa = .41-1). In the physical therapists' group, the inter-rater reliability of four gait deviations was moderate (kappa = .41-.6). In the certified prosthetists' group, the inter-rater reliability of six gait deviations was moderate to substantial (kappa = .41-.8). Three gait deviations achieved moderate agreement in both groups of clinicians (kappa = .41-.6). CONCLUSIONS: Most gait deviations included in the Functional Lower-Limb Amputee Gait Assessment appear stable over time when used by the same clinician. Six gait deviations in the certified prosthetists' group and four in the physical therapists' group may be used by multiple clinicians, and three gait deviations may be used across both professions to assist in communication and collaboration on the best course of treatment for a patient with a unilateral lower limb amputation.

Development of an item bank for measuring prosthetic mobility in people with lower limb amputation: The Prosthetic Limb Users Survey of Mobility (PLUS-M).

BACKGROUND: Achieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and psychometric limitations that inhibit their use in clinical care and research. OBJECTIVE: To develop a brief, clinically meaningful, and psychometrically robust PROM to measure prosthetic mobility. DESIGN: A cross-sectional study was conducted to administer previously developed candidate items to a national sample of lower limb prosthesis users. Items were calibrated to an item response theory model and two fixed-length short forms were created. Instruments were assessed for readability, effective range of measurement, agreement with the full item bank, ceiling and floor effects, convergent validity, and known groups validity. SETTING: Participants were recruited using flyers posted in hospitals and prosthetics clinics across the United States, magazine advertisements, notices posted to consumer websites, and direct mailings. PARTICIPANTS: Adult prosthesis users (N = 1091) with unilateral lower limb amputation due to traumatic or dysvascular causes. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Candidate items (N = 105) were administered along with the Patient Reported Outcome Measurement Information System Brief Profile, Prosthesis Evaluation Questionnaire - Mobility Subscale, and Activities-Specific Balance Confidence Scale, and questions created to characterize respondents. RESULTS: A bank of 44 calibrated self-report items, termed the Prosthetic Limb Users Survey of Mobility (PLUS-M), was produced. Clinical and statistical criteria were used to select items for 7- and 12-item short forms. PLUS-M instruments had an 8th grade reading level, measured with precision across a wide range of respondents, exhibited little-to-no ceiling or floor effects, correlated expectedly with scores from existing PROMs, and differentiated between groups of respondents expected to have different levels of mobility. CONCLUSION: The PLUS-M appears to be well suited to measuring prosthetic mobility in people with lower limb amputation. PLUS-M instruments are recommended for use in clinical and research settings.

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.

Comparison of prosthetic mobility and balance in transfemoral amputees with bone-anchored prosthesis vs. socket prosthesis.

BACKGROUND: The literature comparing bone-anchored prosthesis (BAP) with socket prosthesis (SP) consistently reports improvement in physical health and quality of life using primarily patient-reported outcome measures (PROMs). OBJECTIVE: To determine the differences in mobility and balance using performance-based outcome measures and PROMs in people with transfemoral amputations (TFAs) fitted with BAP vs. SP. STUDY DESIGN: Causal comparative. METHODS: Two groups of people with TFAs were recruited: one using a BAP (N = 11; mean age ± standard deviation, 44 ± 14.9 years; mean residual limb length as a percentage of the intact femur, 68% ± 15.9) and another group using a SP (N = 11; mean age ± standard deviation, 49.6 ± 16.0 years; mean residual limb length as a percentage of the intact femur, 81% ± 13.9), and completed the 10-meter walk test, component timed-up-and-go, Prosthetic Limb Users Survey of Mobility™ 12-item, and Activities-specific Balance Confidence Scale. RESULTS: There were no statistically significant differences between the BAP and SP groups in temporal spatial gait parameters and prosthetic mobility as measured by the 10-meter walk test and component timed-up-and-go, yet large effect sizes were found for several variables. In addition, Activities-specific Balance Confidence Scale and Prosthetic Limb Users Survey of Mobility™ scores were not statistically different between the BAP and SP groups, yet a large effect sizes were found for both variables. CONCLUSIONS: This study found that people with TFA who use a BAP can demonstrate similar temporal spatial gait parameters and prosthetic mobility, as well as self-perceived balance confidence and prosthetic mobility as SP users. Therefore, suggesting that the osseointegration reconstruction surgical procedure provides an alternative option for a specific population with TFA who cannot wear nor have limitations with a SP. Future research with a larger sample and other performance-based outcome measures and PROMs of prosthetic mobility and balance would further determine the differences between the prosthetic options.

Using theoretical frameworks to examine fall history and associated prosthetic mobility in people with nondysvascular lower limb amputation.

BACKGROUND: Over a million people live with lower limb amputation (LLA) in the United States, and many of them will experience a fall in the next year. The aim of this study was to use existing theoretical frameworks in an attempt to organize the complex interactions of reported fall history and prosthetic mobility in community-ambulating people with LLA. METHODS: Self-reported fall rate and fall circumstances were recorded in a cross-section of people with unilateral LLA due to nondysvascular causes. Self-report and performance-based standardized outcome measures assessed prosthetic mobility and balance confidence. All variables were considered and appropriately placed within a proposed International Classification of Functioning, Disability, and Health framework while using a fall-type classification framework to classify fall circumstances. RESULTS: Information from 69 participants was analyzed. The reported fall rate was at 46%, with those with transfemoral amputation reporting significantly more falls than those with transtibial amputation ( P = 0.001). Tripping over an object was the most common cause (62.5%), and fallers reported significantly lower perceived prosthetic mobility than nonfallers ( P = 0.001). Despite reporting high levels of balance confidence, results indicate that all groups of fallers and nonfallers are at increased fall risk according to performance-based prosthetic mobility score cutoffs. CONCLUSIONS: Community-dwelling people with nondysvascular LLA are at increased fall risk. Classifying fall-related variables using theoretical frameworks provides a means to structure more informative fall risk surveys for people with LLA in an attempt to identify those at greater risk for falling and its potential detrimental effects.

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.

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.

Variations in 2-Minute Walk Test outcomes for people with lower limb amputation in the outpatient clinic and research settings.

BACKGROUND: This study determined the differences in 2-Minute Walk Test (2MWT) distances between people with lower limb amputations in clinical and research settings and described variations in test administration in various clinical settings. STUDY DESIGN: Retrospective Cross-sectional design. METHODS: The 2MWT for 290 patients with lower limb amputations were obtained from a medium-sized prosthetic company with locations within the central United States. Data on 12 prosthetists' 2MWT administration decisions were obtained from the results of an administrative questionnaire. Patient 2MWT distances were compared with published distances. Multiple regression was used to examine the impact of test settings on 2MWT outcomes. Descriptive statistics were used to present prosthetists' variations in test administration. RESULTS: Clinical 2MWT distances were significantly less than distances obtained in a research setting. Clinical facilities reported inconsistent path dimensions and potential obstacles in proximity to the test area. Variations in test administration by prosthetists with respect to path length, instructions, turn marker, and overage measurement may contribute to the differences. CONCLUSIONS: Prosthetists should be aware that comparisons of patients' 2MWT distance in a clinical environment may differ from published results. Although variations in clinical environments are usually nonmodifiable characteristics of the clinical facility, test administration and scoring could be modified.

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.

Usability Assessment of the Rehabilitation Lower-limb Orthopedic Assistive Device by Service Members and Veterans With Lower Limb Loss.

INTRODUCTION: Telehealth is an increasingly common approach to improve healthcare delivery, especially within the Veterans Health Administration and Department of Defense (DoD). Telehealth has diminished many challenges to direct access for clinical follow-up; however, the use of mobile telehealth for specialty rehabilitative care is emerging and is referred to as telerehabilitation. As early adopters of telehealth, the Veterans Affairs and DoD have supported collaborated efforts for programs designed to increase the access and quality of rehabilitative care while improving the functional ability of our service members (SMs) and veterans with lower limb amputation (LLA). The DoD and Veterans Health Administration collaborated on a Mobile Device Outcomes-based Rehabilitation Program (MDORP) to help injured SMs and veterans with LLA. The MDORP project utilized a mobile health system called the Rehabilitative Lower Limb Orthopedic Accommodating Device (ReLOAD) to assess walking quality. The ReLOAD system includes real-time auditory biofeedback to notify the user of their most prominent gait deviation and then recommends exercises that address specific balance and strength impairments. The purpose of this study was to describe the responses to a postintervention survey evaluating the feasibility and usability of ReLOAD completed by SMs and veterans with LLA who used the system for 5 months. MATERIALS AND METHODS: A link to an anonymous usability survey was emailed to all participants who completed MDORP. The survey was modeled after the System Usability Scale, with agreeableness to items rated on a 5-point Likert-style questionnaire in addition to open feedback. Data visualization of Likert-style questionnaires was conducted using ggplot2 and reshape2 statistical packages and was analyzed using R. We obtained institutional review board approval through both Miami Veterans Affairs Healthcare System and Walter Reed National Military Medical Center. RESULTS: The majority of participants reported that they would use the system again for home rehabilitation (65%) and that auditory biofeedback helped them walk better (59%). Participants also suggested that future work should include a greater variety of exercise options and the use of smart phones for the ReLOAD application in addition to the iPad tablet. CONCLUSIONS: The participants provided positive and constructive feedback that will enhance the value and usability of telerehabilitation interventions like the ReLOAD system for future users.

Accuracy of the Region of Limb Stability in Predicting Risk for Lower Limb Injury.

PURPOSE: This study aimed to determine whether a measure of lower limb segment stability derived from body-worn inertial measurement units can predict risk for lower limb musculoskeletal injury in Division I Collegiate Football Players (D1CFP). METHODS: The region of limb stability (ROLS) values were collected in a cohort of D1CFP during preseason. ROLS is a measure of knee joint stability, defined by thigh and shank excursion (cm) in the anterior-posterior and medial-lateral direction during single limb stance. The ROLS symmetry index (SI) (%) is the ratio between lower limb ROLS values where 100% suggests absolute symmetry. RESULTS: One-hundred and four D1CFP participated in this study and were divided into two groups: 1) no previous lower limb injury or no in-season injury (n = 70, "noninjured group") and 2) no previous lower limb injury, but in-season injury requiring surgery (n = 34, "injured group" group). The mean ± SD ROLS SI was 82.86% ± 14.75% and 65.58% ± 16.46% for the noninjured and injured group, respectively. Significant differences in ROLS SI were found between groups (P < 0.001). The ROLS SI demonstrated an area under the curve of 0.8 (P < 0.001; 95% confidence interval = 0.71-0.88) with an SE of 0.04, indicating that the ROLS SI has good predictive accuracy in detecting those healthy D1CFP at risk for lower limb injury resulting in surgery. CONCLUSION: The ROLS SI was found to have good predictive accuracy in detecting individuals at risk for injury that were healthy and asymptomatic during preseason testing. Increase in thigh and shank excursions and/or decrease in SI between lower limbs may be a predictor of risk for future injury.

The Relationship Between Vestibular Sensory Integration and Prosthetic Mobility in Community Ambulators With Unilateral Lower Limb Amputation.

OBJECTIVE: The modified Clinical Test of Sensory Interaction and Balance (mCTSIB) is used to clinically assess vestibular sensory integration (VSI), the process by which the central nervous system integrates vestibular afference to maintain balance. The rate and effects of impaired VSI (IVSI) on prosthetic mobility in people with lower limb amputation (LLA) is unknown. The objective of this study was to use the mCTSIB to classify VSI in active community ambulators with LLA and to examine the relationship between IVSI and prosthetic mobility, as measured by the Component Timed Up and Go (cTUG) test. METHODS: This was a cross-sectional study with a convenience sample of 130 community ambulators with unilateral LLA. Classification of VSI was determined based on a time-based pass/fail mCTSIB performance. Participants were classified as having normal sensory integration (NSI) if they could balance for 30 seconds in every mCTSIB condition. Participants who failed condition 4 exclusively were classified as IVSI. Prosthetic mobility, as measured by the cTUG, was compared between NSI and IVSI groups. RESULTS: Of the 130 participants, 29 (22%) were classified as IVSI and 95 (73%) were classified as having NSI. Prosthetic mobility significantly differed between IVSI and NSI groups, with IVSI participants performing all components of the cTUG significantly slower. Medium to large effect sizes were found between groups during cTUG. CONCLUSIONS: These results suggest that 1 in 5 community ambulators with LLA have IVSI, with associated limitations in balance confidence and prosthetic mobility. IMPACT: The ability to integrate vestibular information was found to have a strong relationship with prosthetic mobility in active community ambulators with LLA, especially with performing a 180-degree step turn. Physical therapists can use the mCTSIB to classify sensory integration during prosthetic rehabilitation and develop an appropriate balance intervention. LAY SUMMARY: Active adults with LLA can use information from their senses to maintain their standing balance. Adults with LLA who have difficulty balancing on foam with closed eyes were slower to get in and out of a chair, walk, and perform a 180-degree step turn.

The Utility of the 2-Minute Walk Test as a Measure of Mobility in People With Lower Limb Amputation.

OBJECTIVES: To establish reference values for the 2-minute walk test (2-MWT) distance and gait speed in people with a lower limb amputation (LLA) who are prosthetic ambulators. Also, to describe the differences in distance and gait speed between sexes, causes of amputation, levels of amputation, health risk classification, functional levels, and age groups. DESIGN: Cross-sectional study. SETTING: National meeting for people with lower limb amputation. PARTICIPANTS: A convenience sample of unilateral people (N=101; 47 men, 54 women; mean age ± SD, 50.9±14.3 y) with an LLA; 48 had a transtibial amputation and 53 had a transfemoral amputation. Participants were classified as either limited community ambulators, community ambulators, or those who exceed basic ambulation skills (K2, n=7; K3, n=70; K4, n=24). INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: 2-MWT performance (ie, distance and gait speed). RESULTS: The mean ± SD 2-MWT distance and gait speed for the entire sample was 143.8±37.5 meters (range, 49-259 m) and 72.1±18.8 meters per minute (range, 25-130 m/min), respectively. Men walked farther (distance: men, 154.2±34.2 m; women, 134.4±38.1 m) and faster (gait speed: men, 77.3±17.1 m/min; women, 67.4±19.1 m/min) than women (P<.05). The mean ± SD 2-MWT distance for K4, K3, and K2 level participants was 177.9±31.1 meters, 138.4±28.5 meters, and 81.7±26.9 meters, respectively. Functional level K4 participants performed better than K3 participants (P<.05), and K3 participants performed better than K2 participants (P<.05). People with transtibial amputation walked farther than those with transfemoral amputation (152.9±43.0 m vs 135.6±43.0 m) (P<.05). The distance and speed ambulated by those participants classified in the very high health risk group was worse than those categorized as being at an increased high health risk group (P<.05) and the no increase health risk group (P<.05). The performance of participants older than 70 years old was inferior to the performance of all younger age groups. CONCLUSIONS: Reference values for the 2-MWT distance and gait speed were established in people with LLA who are prosthetic ambulators. Significant differences in the 2-MWT performance were found between sexes, causes of amputation, levels of amputation, health risk classification, functional levels, and age groups.

The Effectiveness of the DoD/VA Mobile Device Outcomes-Based Rehabilitation Program for High Functioning Service Members and Veterans with Lower Limb Amputation.

INTRODUCTION: The objective was to determine if the Mobile Device Outcomes-based Rehabilitation Program (MDORP) improved strength, mobility, and gait quality in service members (SMs) and Veterans with lower limb amputation (LLA). METHODS: Seven SMs and 10 Veterans with LLA enrolled and were trained to use a mobile sensor system, called Rehabilitative Lower Limb Orthopedic Analysis Device (ReLOAD). ReLOAD provided participants with real-time assessment of gait deviations, subsequent corrective audio feedback, and exercise prescription for normalizing gait at home and in the community. After baseline testing, prosthetic gait and exercise training, participants took ReLOAD home and completed an 8-week walking and home exercise program. Home visits were conducted every 2 weeks to review gait training and home exercises. RESULTS: Significant improvements in hip extensor strength, basic and high-level mobility, musculoskeletal endurance, and gait quality (P < 0.05) were found at the completion of the 8-week intervention. CONCLUSION: Preliminary MDORP results are promising in its ability to improve basic and high-level mobility, lower limb strength, and gait quality in a group of SMs and Veterans with LLA. In addition, "booster" prosthetic training may be justified in an effort helps maintain an active lifestyle, promotes prosthetic use, and mitigates secondary health effects.

Effectiveness of an Evidence-Based Amputee Rehabilitation Program: A Pilot Randomized Controlled Trial.

BACKGROUND: Despite the prevalence of lower limb amputation (LLA), only a small percentage of people with LLA actually receive physical therapy post amputation and are rehabilitated to their full potential level of function. There is a need for the development of a rehabilitation program that targets impairments and limitations specific to people with LLA. OBJECTIVE: The objective of this study was to determine whether the Evidence-Based Amputee Rehabilitation program would improve functional mobility of people with unilateral transtibial amputation (TTA) who have already completed physical therapy and prosthetic training. DESIGN: This study was a randomized, wait-list control, single-blinded pilot clinical trial. SETTING: This study researched participants who had received postamputation rehabilitation to varying degrees, either in an inpatient and/or outpatient settings. PARTICIPANTS: The participants in this study included veterans and nonveterans with unilateral TTA due to dysvascular disease and trauma. INTERVENTION: This study included a prescription-based rehabilitation program for people with amputations. MEASUREMENTS: Results were measured with The Amputee Mobility Predictor with (AMPPro) and without a prosthesis (AMPnoPro) and 6-Minute Walk Test (6MWT) at baseline and at the end of the 8-week intervention. RESULTS: The intervention group improved on the AMPPro scores (36.4 to 41.7), AMPnoro scores (23.2 to 27.1), and 6MWT distance (313.6 to 387.7 m). The effect size for the intervention was very large (1.32). In contrast, the wait-list control group demonstrated no change in AMPPro scores (35.3 to 35.6), AMPnoPro scores (24.7 to 25.0), and 6MWT distance (262.6 m to 268.8 m). LIMITATIONS: The sample size was small. A total 326 potential candidates were screened with 306 unable to meet inclusion criteria or unwilling to participate. CONCLUSION: People with unilateral TTA who received Evidence-Based Amputee Rehabilitation program demonstrated significant improvement in functional mobility, with most participants (66.7%) improved at least 1 K-level (58.3%) and greater than the minimal detectable change (66.7%).

Quantification of Agility Testing with Inertial Sensors after a Knee Injury.

INTRODUCTION: A common criterion in decision making regarding return to sport (RTS) after knee ligament injury is that athletes should achieve symmetrical bilateral movement between the injured limb and the noninjured limb. Body-worn wireless inertial measurement units (IMU) can provide clinicians with valuable information about lower-limb kinematics and athletic performance. METHODS: The IMU-based novel kinematic metrics were developed. The Transitional Angular Displacement of Segment (TADS) and Symmetry Index (SI) measures that quantify lower-limb motions and interlimb symmetry during the 4-m side step test (FmSST) were developed. Test-retest reliability was measured in 20 healthy adults. Experimental application of the metrics was also determined in 15 National Collegiate Athletic Association Division I collegiate athletes who completed rehabilitation after a knee ligament injury. RESULTS: The intraclass correlation coefficient for test-retest reliability for FmSST, TADS right lower limb, TADS left lower limb, and TADS SI was 0.90 (95% confidence interval, [0.61-0.95]); 0.87 [0.63-0.96]; 0.89 [0.64-0.96], and 0.81 [0.58-0.92], respectively. The differences between TADS SI at baseline (preinjury) and RTS were also compared with those between the total times for performing the FmSST at baseline and RTS. There was no significant difference in the FmSST times between baseline and RTS (P = 0.32); however, TADS SI at the time of RTS was significantly lower than at baseline (P = 0.046). A large effect size (d = -1.04) was observed for the change in TADS SI from baseline to RTS. CONCLUSIONS: Using IMU sensor technology can provide quantitative and discrete analysis to detect kinematic differences during agility after a knee ligament injury in the field or nonlaboratory setting. This approach has the potential to help clinicians improve decisions about rehabilitation at a time when an athlete is reintegrating back into sport.

Variables that Influence Basic Prosthetic Mobility in People With Non-Vascular Lower Limb Amputation.

BACKGROUND: There exists a dearth of evidence on rehabilitation factors that influence prosthetic mobility in people with lower limb amputation (LLA). Examining variables that contribute to prosthetic mobility can inform rehabilitation interventions, providing guidance in developing more comprehensive care for these individuals. OBJECTIVE: To determine the influence of modifiable and non-modifiable variables related to LLA and their impact on prosthetic mobility, using the International Classification of Functioning, Disability and Health (ICF) model. Secondarily, to determine if personal factors and self-reported balance and mobility are predictive of Component timed-up-and-go (cTUG) performance. DESIGN: Cross-sectional study of a convenience sample. SETTING: National conference. PARTICIPANTS: People (N=68) with non-vascular causes of unilateral LLA. METHODS: Assessment of anthropometrics, mobility, bilateral hip extensor strength, hip range of motion, single limb balance, and self report measures. Lasso linear regression and extreme gradient boosting analyses were used to determine influence of variables on prosthetic mobility. MAIN OUTCOME MEASURE: Timed performance of the cTUG. RESULTS: The following five variables were found to influence basic prosthetic mobility (P ≤ .05) in people with transtibial amputation: hip extensor strength, hip range of motion, single limb balance, waist circumference, and age. In the transfemoral cohort, number of comorbidities and waist circumference primarily influenced prosthetic mobility. Additionally, 66% of the variance in cTUG total time for the entire sample could be explained by simply regressing on level of amputation, number of comorbidities, age and Activities-specific Balance Confidence scale score, all variables easily collected in a waiting room. CONCLUSION: Variables that are modifiable with physical therapy intervention including hip extensor strength, hip range of motion, single limb balance, and waist circumference significantly influenced basic prosthetic mobility. These variables can be affected by targeted rehabilitation interventions and lifestyle changes. LEVEL OF EVIDENCE: II.

Inertial sensor-based measures of gait symmetry and repeatability in people with unilateral lower limb amputation.

BACKGROUND: People with lower limb amputation often walk with asymmetrical gait patterns potentially leading to long-term health problems, ultimately affecting their quality of life. The ability to discreetly detect and quantify the movement of bilateral thighs and shanks using wearable sensor technology can provide additional insight into how a person walks with a lower limb prosthesis. This study investigated segmental symmetry and segmental repeatability of people with unilateral lower limb amputation, examining performance of the prosthetic and intact limbs. METHODS: Gyroscope signals were recorded from four inertial measurement units worn on bilateral lower limb segments of subjects with unilateral lower limb amputation during the 10-m walk test. Raw angular velocity signals were processed using dynamic time warping and application of algorithms resulting in symmetry measures comparing similarity of prosthetic to intact limb strides, and repeatability measures comparing movement of one limb to its consecutive strides. FINDINGS: Biomechanical differences in performance of the prosthetic and intact limb segments were detected with the segmental symmetry and segmental repeatability measures in 128 subjects. More asymmetries and less consistent movements of the lower limbs were exhibited by subjects with transfemoral amputation versus transtibial amputation (p < .004, Cohen's d = 0.65-1.1). INTERPRETATION: Sensor-based measures of segmental symmetry and segmental repeatability were found to be reliable in detecting discreet differences in movement of the prosthetic versus intact lower limbs in amputee subjects. These measures provide a convenient tool for enhanced prosthetic gait analysis with the potential to focus rehabilitative and prosthetic interventions.

POST-CONCUSSIVE CHANGES IN BALANCE AND POSTURAL STABILITY MEASURED WITH CANESENSE™ AND THE BALANCE ERROR SCORING SYSTEM (BESS) IN DIVISION I COLLEGIATE FOOTBALL PLAYERS: A CASE SERIES.

INTRODUCTION: Impairments in postural stability have been identified following sports-related concussion. CaneSense™ is a recently developed mobile lower limb motion capture system and mobile application for movement assessment which provides an objective measure of postural stability. One of the components within CaneSense™ is the Post-Concussive Excursion Index (PCEI), a measure of postural stability expressed as a percentage of symmetry between lower limbs. PURPOSE: The purpose of this case series is to examine pre- and post-concussion differences using two separate measures, CaneSense™, and a known test, the Balance Error Scoring System (BESS), in Division I collegiate football players. METHODS: A convenience sample of eight football players diagnosed with a concussion, were the subjects in this case series. All subjects underwent baseline testing prior to the start of pre-season camp consisting of the single limb stance (SLS) test with CaneSense™ and the BESS test. Twenty-four to 72 hours following their concussion, SLS with CaneSense™ test and the BESS test, were administered. Segmental excursions for the thigh and shank segments for each lower limb were combined into the Post-Concussion Excursion Profile (PCEP), which represents each segment's maximum excursion in the medial-lateral and anterior-posterior direction. The PCEI is a single metric generated to quantify differences within subjects by comparing the PCEP value between lower limbs during SLS where 100% suggests absolute symmetry. RESULTS: The PCEI value decreased significantly post-concussion (41.43 ± 15.53% vs. 87.41 ± 6.05%, p < 0.001) demonstrating a 52.6% decrease in inter-limb symmetry when compared to baseline values. There was an unanticipated 36.36% improvement in composite BESS performance post-concussion (10.5 ± 4.87 errors vs. 16.5 ± 8.49 errors, p = 0.10). CONCLUSIONS: Differences in inter-limb postural stability were found in subjects post-concussion. By assessing postural stability in both lower limbs individually, using the PCEI, impairments were detected that otherwise would have likely gone undiagnosed using the BESS test alone. LEVELS OF EVIDENCE: Therapy, Level 4.

Construct validation of lower limb segmental excursion as a measure of potential risk for lower limb injury in Division I women's basketball players.

The region of limb stability (ROLS) is an inertial sensor-based measure of static knee joint stability, defined by thigh and shank movements of the supporting limb during single limb stance. Changes in thigh and shank movements and/or symmetry differences between limbs may predict risk of injury to the less stable limb or the need for rehabilitation. In this study, construct validity of the ROLS metrics was examined in twelve Division I women's basketball players during pre-season in preparation for their exercise training program. The subjects were categorized based on their injury history during the season: (Group 1) No reported injuries throughout the season, (Group 2) lower limb injury that did not result in missing any games, and (Group 3) lower limb injury that resulted in missing both practice and the remainder of their season. Significant differences were found in ROLS metrics at pre-season between Group 3 and other groups in a prospective cohort study (p < 0.05). Study findings provided pilot data for supporting ROLS as a measure of postural stability impairment and potential risk for lower limb injury in athletes.