Understanding the multidimensionality of a concern for falling in people with unilateral transtibial amputation: a cross-sectional study

International Journal of Rehabilitation Research Understanding the multidimensionality of a concern for falling in people with unilateral trans-tibial amputation: A cross-sectional study --Manuscript Draft-- Manuscript Number: IJRR-D-24-00275R3 Full Title: Understanding the multidimensionality of a concern for falling in people with unilateral trans-tibial amputation: A cross-sectional study Article Type: Original Study Keywords: amputation; concern for falling; falls; prosthesis Corresponding Author: Kristin Nugent, M.Sc. University of Western Ontario Faculty of Health Sciences: Western University Faculty of Health Sciences London, Ontario CANADA Corresponding Author Secondary Information: Corresponding Author's Institution: University of Western Ontario Faculty of Health Sciences: Western University Faculty of Health Sciences Corresponding Author's Secondary Institution: First Author: Kristin Nugent, MSc First Author Secondary Information: Order of Authors: Kristin Nugent, MSc Ricardo Viana, MScOT MD Michael W Payne, MSc MD Janelle Unger, PT PhD Susan W Hunter, PT PhD Order of Authors Secondary Information: Manuscript Region of Origin: CANADA Abstract: People with lower limb loss have a high risk of falling and often experience psychological concerns related to falling. A concern for falling is a multidimensional term that includes four subdomains: a fear of falling, self-efficacy, consequences of falling and perceptions of falls. There is limited knowledge in the literature about the delineation and association between subdomains in the concern for falling framework, and it is unknown if clinical factors and history of falls is associated with the concern for falling subdomains. This cross-sectional online survey evaluated the: 1) associations among different outcome measures for a concern for falling; 2) relationships between falls history with the different measures; and 3) clinical and demographic factors related with each outcome measure. Inclusion criteria:≥18 years old, unilateral trans-tibial amputation and currently using a prosthesis for ambulation. Exclusion criteria: unable to provide informed consent. Eight standardized scales assessed a concern for falling: visual analog scale fear of falling, Modified Survey of Activities and Fear of Falling in the Elderly, Activities-specific Balance Confidence scale, Falls Efficacy Scale International, Prosthetic Limb Users Survey – Mobility, Locomotor Capabilities Index, Consequences of Falling Scale and Perceived Ability to Manage Falls. The association among the eight concern for falling scales was performed using Pearson bivariate correlation analysis. The association of falls status on the scores was performed with ttests. Multiple linear regression modelled the clinical and demographic factors related to each outcome measure. Sixty-eight adults (mean 61.8±12.0) with unilateral transtibial amputation participated. Moderate statistically significant correlations were found across most outcome measures, with the strongest correlations found between the PLUS-M and mSAFFE (r=-0.841, p<0.001), ABC and FES-I (r=-10.821, p<0.001) and Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation PLUS-M and ABC (r=0.819, p<0.001). Faller status was not associated with any outcome measure (p>0.05). The R2 for models examining the association of quality of life with fear of falling, avoidance of activities, self-efficacy and certainty to managing falls ranged between 0.27 and 0.47. Concern for falling should be evaluated independently of history of falls among PWLLL. Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation 1 Understanding the multidimensionality of a concern for falling in people with unilateral 1 trans-tibial amputation: A cross-sectional study 2 Running head: Concern for falling in transtibial amputees 3 4 Kristin Nugent1, Ricardo Viana2, Michael W Payne2, Janelle Unger1, Susan W Hunter1 5 1. School of Physical Therapy, University of Western Ontario, London, ON, Canada 6 2. Department of Physical Medicine & Rehabilitation, Schulich School of Medicine & 7 Dentistry, University of Western Ontario 8 9 Corresponding author: 10 Kristin Nugent MSc 11 School of Physical Therapy, University of Western Ontario, 1201 Western Road, London, ON 12 N6G 1H1, Email: [email protected] 13 14 Author disclosures: Nothing to disclose. 15 Conflicts of interest: The authors have nothing to disclose. 16 Source of funding: This work was supported by a Ontario Graduate Scholarship for Kristin 17 Nugent. The funding body had no involvement in the conduct of the study. 18 19 20 Manuscript (All Manuscript Text Pages in MS Word format, including Title Page, References and Figure Legends) 2 Word count for abstract: 328 21 Word count for main text, abstract, and figure and table captions: 4237 22 Number of tables: 4 23 Number of figures: 1 24 3 ABSTRACT 25 People with lower limb loss have a high risk of falling and often experience psychological 26 concerns related to falling. A concern for falling is a multidimensional term that includes four 27 subdomains: a fear of falling, self-efficacy, consequences of falling and perceptions of falls. 28 There is limited knowledge in the literature about the delineation and association between 29 subdomains in the concern for falling framework, and it is unknown if clinical factors and history 30 of falls is associated with the concern for falling subdomains. This cross-sectional online survey 31 evaluated the: 1) associations among different outcome measures for a concern for falling; 2) 32 relationships between falls history with the different measures; and 3) clinical and demographic 33 factors related with each outcome measure. Inclusion criteria: 18 years old, unilateral trans34 tibial amputation and currently using a prosthesis for ambulation. Exclusion criteria: unable to 35 provide informed consent. Eight standardized scales assessed a concern for falling: visual analog 36 scale fear of falling, Modified Survey of Activities and Fear of Falling in the Elderly, Activities37 specific Balance Confidence scale, Falls Efficacy Scale International, Prosthetic Limb Users 38 Survey – Mobility, Locomotor Capabilities Index, Consequences of Falling Scale and Perceived 39 Ability to Manage Falls. The association among the eight concern for falling scales was 40 performed using Pearson bivariate correlation analysis. The association of falls status on the 41 scores was performed with t-tests. Multiple linear regression modelled the clinical and 42 demographic factors related to each outcome measure. Sixty-eight adults (mean 61.8±12.0) with 43 unilateral trans-tibial amputation participated. Moderate statistically significant correlations were 44 found across most outcome measures, with the strongest correlations found between the PLUS45 M and mSAFFE (r=-0.841, p<0.001), ABC and FES-I (r=-10.821, p<0.001) and PLUS-M and 46 ABC (r=0.819, p<0.001). Faller status was not associated with any outcome measure (p>0.05). 47 4 The R2 for models examining the association of quality of life with fear of falling, avoidance of 48 activities, self-efficacy and certainty to managing falls ranged between 0.27 and 0.47. Concern 49 for falling should be evaluated independently of history of falls among PWLLL. 50 51 Key words: amputation, concern for falling, falls, prosthesis 52 5 INTRODUCTION 53 People with lower limb loss (PWLLL) have a high risk of falling, even for those who 54 have successfully completed a prosthetic rehabilitation program.[1] Over 50% of PWLLL sustain 55 at least one fall a year[2,3] and most falls occur while the person is walking with their 56 prosthesis[4]. The majority of PWLLL in Canada have a trans-tibial level amputation due to a 57 dysvascular etiology.[5] Risk factors for falls among PWLLL include increasing age, balance or 58 gait impairments, a higher level of amputation (e.g., trans-tibial compared to Symes or below 59 ankle) and a dysvascular amputation etiology.[1] Additionally, recalled number of falls, balance 60 confidence and perceived mobility are also associated with future falls in PWLLL.[6,7] 61 Falls for PWLLL can result in long-term adverse sequelae that affect both physical and 62 psychological function.[8,9] While the physical consequences of falls may be readily apparent to 63 the outside observer[10] (e.g., fractures, laceration, dehiscence of the stump wound), the 64 psychological effects require a thorough subjective history along with standardized 65 questionnaires to define and quantify the issue.[11] Amputee rehabilitation clinicians have 66 reported anecdotal concerns about the mismatch between patients’ perceived concerns about 67 falling and their reported history of falls. To address this concern and reduce falls among 68 PWLLL, quantifying both concern for falling and falls history, and demonstrating the mismatch 69 to the patient, may be the most comprehensive approach. Therefore, assessing a concern for 70 falling both in relation to and independently of falls history is necessary to better understand this 71 issue in PWLLL. 72 Moore and Ellis[12] described a concern for falling as a multidimensional, overarching 73 term that includes multiple complex psychological effects, which are related but have distinct 74 elements that differentiates them from one another. The concern for falling framework was 75 6 adapted and applied to PWLLL by Nugent et al.[13] delineating five distinct subdomains: 1) fear 76 of falling (lasting concern about falling that leads an individual to avoid activities that they are 77 physically capable of performing); 2) falls efficacy (confidence in one’s ability to perform 78 activities of daily living without falling); 3) mobility efficacy (confidence in one’s ability to 79 perform normal daily activities without difficulty); 4) consequences of falling (feared outcomes 80 as a result of falling); and 5) perception of falls (an individual’s knowledge of and belief in their 81 ability to have control over falling). Associations indicate relationships between two constructs. 82 A perfect association would suggest that one construct be used interchangeably with the other, as 83 both would address the same aspects.[14] However, when associations are not perfect, it 84 provides evidence that the constructs while related, capture distinct aspects.[14] This implies that 85 although there may be overlap, each construct has specific difference that are reflected in one 86 outcome measure but not the other.[14] Despite clear definitions of each of the concern for 87 falling subdomains, the terms have been used interchangeably in the literature.[15] Our previous 88 publications used the preliminary results of this larger database, which demonstrated the 89 statistically significant association with a concern for falling has on overall quality of life for 90 PWLLL, but did not fully explain the variance in the relationship.[13] Previous research has 91 shown that within each subdomain of a concern for falling, different outcome measures evaluate 92 distinct constructs, making it necessary to use multiple outcome measures to fully evaluate each 93 subdomain.[13] 94 The lack of differentiation in this terminology limits clinicians to accurately define a 95 concern for falling among PWLLL and the identification and implementation of intervention 96 strategies.[16] The existing literature related to a concern for falling in PWLLL has focused on 97 balance confidence, fear of falling and falls knowledge. Hunter et al.[17] found balance 98 7 confidence to be low among PWLLL after completing prosthetic rehabilitation and did not 99 improve at three months after discharge. Falls-related self-efficacy, the belief that a person can 100 perform an activity without falling, has been found to remain unchanged in the first 6 to 12 101 months after prosthetic rehabilitation despite a significant improvement in functional 102 mobility.[8,16] Miller et al.[9] found 49.2% of PWLLL living in the community reported a fear 103 of falling. Fear of falling contributes to a decreased falls-related self-efficacy that contributes to 104 the overall psychological concerns related to falls and decreased community participation.[16] 105 The literature on a concern for falling among PWLLL lacks comprehensive evaluation, 106 defined as assessing at least one outcome measure within each subdomain of the concern for 107 falling framework, of how these subdomains may be influenced by a history of falls. To address 108 this gap, an evaluation of the relationships between different subdomains of a concern for falling 109 among PWLLL is indicated. The objectives of the study were to evaluate the associations among 110 different outcome measures related to a concern for falling, to assess the relationship between 111 falls history and a concern for falling, and to examine the influence of clinical and demographic 112 factors on each of the outcome measures for a concern for falling. 113 It was hypothesized that the eight concern for falling outcome measures will have 114 moderate to strong statistically significant correlations with one another. Second, it was 115 hypothesized that history of falls will not be statistically significantly associated with each 116 concern for falling outcome measure. Finally, it was hypothesized that clinical and demographic 117 factors would be associated with outcome measures related to a concern for falling. 118 METHODS 119 Study participants 120 14 medications was associated with reduced mobility efficacy and reduced certainty about 258 managing any falls. The use of a mobility aid was associated with increased balance confidence. 259 DISCUSSION 260 This study evaluated a comprehensive set of outcome measures for a concern for falling 261 in a sample of people with unilateral trans-tibial limb loss. The outcome measures were 262 consistently aligned across the subdomains; low fear of falling was associated with high balance 263 confidence, lower activity avoidance, stronger falls efficacy, better mobility efficacy, increased 264 agency to prevent falls and fewer concerns regarding adverse consequences. While the total 265 scores for the eight outcome measures were moderately correlated, the items within each 266 measures were moderately correlated, the individual items within each measure were not 267 uniformly repeated across all the scales. 268 While the total scores for the eight outcome measures were moderately correlated, the 269 items within each measure were not uniformly repeated across all the scales. Recurrent faller 270 status in the last 12 months was not statistically significant to any of the outcome measure total 271 scores. However, quality of life was associated with total scores for all outcome measures in the 272 linear regression modelling. Specifically, increasing quality of life was associated with less fear 273 of falling, less avoidance of activities, better self-efficacy and better certainty in managing any 274 falls the person might experience. 275 Consistent with Moore and Ellis[12] review of psychological constructs in falls, we 276 found moderate correlations among the total eight outcome measures covering five subdomains 277 of a concern for falling. While the constructs are related within the concern for falling 278 framework, they are distinct from one another, and terminology for each construct is not 279 interchangeable[11] nor perfectly correlated[12]. It is crucial for researchers to ensure that the 280 15 instruments they use align with the specific constructs they aim to assess. To ensure consistency 281 across research and clinical practice, the construct being measured, and the instrument being 282 used to measure, are aligned with the construct of interest.[15] Clinicians evaluating a concern 283 for falling in PWLLL should incorporate multiple outcomes measures to comprehensively 284 evaluate the constructs of each subdomain. Using a variety of tools captures unique elements of a 285 concern for falling, which may be missed by a single scale, and provides a more holistic view of 286 the patient’s needs. 287 Importantly, there was no association between faller status and scores on the concern for 288 falling outcome measures in our study, suggesting that falls history may not be the sole or most 289 accurate predictor of falls risk in PWLLL. Consistent with falls prevention and management 290 guidelines in older adults,[30] it is important to ask about a concern for falling in combination 291 with physical function assessment and history of falls. 292 Falls in PWLLL have well-documented physical and psychological consequences.[31] 293 The psychological impact of falls, including self-imposed activity restrictions, can lead to a 294 decrease in muscle strength, balance and gait problems, reduced endurance, social isolation and 295 decreased quality of life.[8] These psychological effects can both result from and contribute to 296 future falls. Barnett et al.[32] demonstrated that lower objective measures of postural stability 297 was associated with lower future falls efficacy measured at 6 months from baseline. 298 Additionally, recent research by Tobaigy et al.[6,7] has reported a relationships between physical 299 function, balance confidence, and mobility efficacy in predicting future falls in PWLLL. 300 Previous research has demonstrated that PWLLL who have completed a prosthetic 301 rehabilitation program exhibited a gap between their knowledge of falls and how to prevent 302 falls.[33] The relationship between the identification of barriers and facilitators to the 303 16 implementation of falls prevention strategies on a concern for falling warrants research to define 304 effective strategies for use in rehabilitation of PWLLL. 305 Higher quality of life was associated with positive shifts across all subdomains of a 306 concern for falling, highlighting the importance of viewing rehabilitation and community 307 integration that focuses on both physical and psychological needs of PWLLL. Previous research 308 has shown that despite PWLLL completing a comprehensive prosthetic rehabilitation program, 309 they often exhibit gaps in their knowledge of falls prevention strategies.[33] Addressing these 310 gaps through targeted interventions could enhance falls prevention and promote greater social 311 engagement, as high balance confidence has been shown to increase participation in social 312 activities.[13] 313 Several limitations should be noted. This was a convenience sample of people who 314 attended our facility’s outpatient amputee rehabilitation program and does not represent all 315 people who attend our facility or all PWLLL. The study focused on people with a trans-tibial 316 amputation to limit heterogeneity, as bilateral and trans-femoral amputations are associated with 317 different capabilities for gait, balance, falls risk and prosthesis use.[34] Future studies should 318 adopt a multi-center approach to recruit participants with various levels of limb loss that allow 319 for subgroup analyses based on the level of amputation. Finally, a limitation of this study is the 320 lack of precision in the participant clinical factor responses, as it did not account for more 321 detailed reporting on prosthesis fitting and time since discharge from prosthetic rehabilitation, 322 which warrants further exploration. Despite these limitations, this study has several strengths. 323 The outcome measures used in this study represent measures that are used in clinical and 324 research practice in this population. Two measures were included among the complement of tests 325 that were developed specifically for PWLLL. Future research should evaluate the validity of 326 17 content among the remaining measures. The outcome measures used in this study have 327 psychometric properties acceptable for use in PWLLL and have reliability values for use in an 328 online format. This study contributes to the growing body of literature by providing an in-depth 329 assessment of the psychological and physical constructs associated with concern for falling in 330 PWLLL which will inform future interventions and clinical practice. 331 CONCLUSION 332 This study evaluated a comprehensive set of outcomes measures for a concern for falling 333 in people with unilateral trans-tibial limb loss. Many of the concern for falling outcome measures 334 demonstrated moderate and statistically significant associations to one another but were not 335 perfectly aligned in terms of their correlation or item content. Therefore, they should not be used 336 interchangeably to evaluate the same construct. There was an alignment of scores across the 337 scales, such that a low fear of falling was correlated with a high balance confidence, low activity 338 avoidance, good falls efficacy, good mobility efficacy, high agency to prevent falls and a low 339 concern of adverse consequences. Recurrent faller status in the last 12 months was not associated 340 to any of the outcome measure total scores. Higher quality of life was associated with less fear of 341 falling, less avoidance of activities, better self-efficacy and better certainty in managing any falls 342 the person might experience. 343 344 345 346 347 348 349 18 REFERENCES 350 1. Hunter SW, Batchelor F, Hill KD, Hill AM, Mackintosh S, Payne M. Risk Factors for 351 Falls in People With a Lower Limb Amputation: A Systematic Review. PM R. 352 2017;9(2):170-180.e1. doi:10.1016/j.pmrj.2016.07.531 353 2. Kim J, Major MJ, Hafner B, Sawers A. 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Arch Phys Med Rehabil. 454 1999;80(6):706-713. doi:10.1016/S0003-9993(99)90177-6 455 456 457 458 459 460 461 462 463 464 23 Table and Figure Legend: 465 Table 1. Demographic and clinical characteristics of a sample of community-dwelling adults 466 with unilateral trans-tibial amputation. (n=68) 467 Table 2. Results of bivariate Pearson correlation analysis of eight outcome measures of a 468 concern for falling in unilateral trans-tibial amputees. 469 Table 3. Concern for falling outcome measure total scores reported for whole sample and 470 stratified by falls history in past 12 months among people with unilateral trans-tibial 471 amputations. (n=68) 472 Table 4. Results of step-wise linear regression modelling to identify factors associated with total 473 scores on measures of a concern for falling in unilateral trans-tibial amputees. (n=68) 474 Figure 1. Radar plot of total average scores as a percent of the maximum score on eight 475 measures of a concern for falling in people with a unilateral trans-tibial amputation. (n=68) 476 477 478 479 480 481 482 483 484 485 486 487 LCI 44.3 (13.5) 46.8 (12.1) 40.7 (14.8) 0.066 Consequences CoF 24.8 (7.0) 23.9 (6.1) 25.9 (8.1) 0.249 Control over Falling PAMF 15.6 (2.9) 15.7 (3.1) 15.5 (2.7) 0.782 Note: ABC, Activities-specific Balance Confidence Scale; CoF, Consequences of Falls Scale; FES-I, Falls Efficacy Scale International; mSAFFE, modified Survey of Activities and Fear of Falling in the Elderly; LCI, Locomotor Capabilities Index; PCOF, Perceived Control over Falling Scale; PAMF, Perceived Ability to Manage Falls Scale; Fear of Falling VAS, visual analogue scale from 0 (no fear) to 100 (worst fear). High scores for mSAFFE, FES-I, CoF indicate worse outcomes. High scores on VAS, ABC, PLUS-M, LCI and PAMF indicate good outcomes. Table 4. Regression Model Outcome Measure Explanatory Variables Unstandardized ß Coefficient (95% CI) p-value R2 for Model Fear of Falling 1 Visual analog scale Falls history 21.5 (2.46, 40.46) 0.028 0.44 Quality of Life -0.80 (-1.15, -0.45) <0.001 2 mSAFFE Quality of Life -0.14 (-0.22, -0.06) 0.001 0.30 Self-Efficacy 3 ABC Quality of Life 0.37 (0.13, 0.61) 0.004 0.34 Gait aid use 15.08 (1.09, 29.07) 0.036 4 FES-I Quality of Life -0.29 (-0.40, -0.17) <0.001 0.47 Mobility Efficacy 5 PLUS-M Quality of life 0.14 (0.01, 0.28) 0.041 0.44 Number of medications -0.68 (-1.42, 0.07) 0.073 6 LCI Quality of life 0.14 (-0.02, 0.29) 0.085 0.32 Number of medications -1.16 (-2.02, -0.29) 0.011 Table 4 Consequences 7 CoF Quality of life -0.20 (-0.28, -0.12) <0.001 0.47 Control over falling 8 PAMF Quality of life 0.08 (0.05, 0.11) <0.001 0.27 Number of medications -0.17 (-0.34, 0.01) 0.057 Note: ABC, Activities-specific Balance Confidence Scale; CoF, Consequences of Falls Scale; FES-I, Falls Efficacy Scale International; mSAFFE, modified Survey of Activities and Fear of Falling in the Elderly; PLUS-M, Prosthetic Limb User Survey – Mobility; LCI, Locomotor Capabilities Index; PCOF, Perceived Control over Falling Scale; PAMF, Perceived Ability to Manage Falls Scale; Fear of Falling VAS, visual analogue scale from 0 (no fear) to 100 (worst fear). High scores for mSAFFE, FES-I, CoF indicate worse outcomes. High scores on VAS, ABC, PLUS-M, LCI and PAMF indicate good outcomes. Variables entered into the step-wise linear regression modelling were age, gender, falls history in past 12 months (yes/no), gait aid use (yes/no), number of medications, quality of life, amputation etiology, Socket Comfort Score. Supplemental Digital Content 1. Comparison of activities evaluated across the multi-item scales use to assessment subdomains for a concern of falling. mSAFFE ABC FES-I LCI PLUS-M Fear avoidance Balance confidence Falls efficacy Mobility efficacy Mobility efficacy Task Get dressed and undressed x Taking a bath or shower x Taking a bath x Taking a shower x Get in and out of chair x x x Get up off the floor if fell x Walk around house x x x x Go to answer the phone before it stops ringing x Walk up and down stairs (use of handrail not stated) x x x Supporting document Walk up and down stairs with use of handrail x Walk up stairs without use of handrail x Walk downstairs without use of handrail x Bend over to pick up something from floor x x x x Reach for small can off shelf at eye level x Prepare simple meals x x Reach for something over head or on ground x x Stand on tiptoes and reach over head x Stand on chair and reach for something x Sweep the floor/cleaning the house x x x Walk outside the house to car in driveway x Walk around the neighbourhood x x x Walk half mile x Go to the shops x x Get in and out of car x Take public transport x Walk across parking lot x Walk up and down ramp/slope x x Step up curb x Step down curb x Step up and down curbs x Visit a friend or relative x x Go to doctor or dentist x Walk carrying an object x x Walk in crowded mall/busy place x x x Able to keep up with others while walking x Go to social event x x Walk in dimly lit and unfamiliar place x x In busy space where you are bumped into by people x x Step on and off escalator holding onto railing x Step on and off escalator without holding onto railing x Walk outside on even surface x Walk on uneven surface x x x Walking on a slippery surface (wet, ice, snow) x x x x Walk outside in inclement weather x Exercising x Move a chair from one room to another x Walk on steep gravel path x Walk 2 miles on an even surface x Note: ABC, Activities-specific Balance Confidence Scale; FES-I, Falls Efficacy Scale International; mSAFFE, modified Survey of Activities and Fear of Falling in the Elderly; PLUS-M, Prosthetic Limb User Survey – Mobility; LCI, Locomotor Capabilities Index.