Abstract
BACKGROUND:
There is an age-related increase in lower limb amputation (LLA) secondary to dysvascular disease, however, the effectiveness of Multi-Disciplinary Team (MDT) is unknown.
PURPOSE:
The aims of the study were to investigate if a) individuals with primary lower limb amputation (IPLLAs) attending a regional outpatient prosthetic rehabilitation service achieve successful mobility outcomes, b) to examine the multi-disciplinary team’s ability to accurately predict mobility outcome in this cohort and c) to evaluate how pre-amputation mobility levels affect mobility outcomes of IPPLAs attending an outpatient rehabilitation service.
METHODS:
This retrospective observational cohort study included 93 primary, unilateral and bilateral IPPLAs at or proximal to the transtibial level. Pre-rehabilitation (baseline) data was collected between one and six weeks after amputation when clients attended for their pre-rehabilitation MDT Assessment. This data (including Specialist Interest in Amputee Medicine (SIGAM) Score and Pre-Amputation Mobility Status) was gathered to establish their rehabilitation needs. Pre-amputation mobility was characterised as 1) Ambulatory (independent ambulation out of house); 2) Ambulatory/homebound (ambulatory in the home only), 3) Nonambulatory/transfer, 4) Nonambulatory/bedridden.
Peri- and post-rehabilitation data (Timed Walking Test (TWT), Locomotor Capabilities Index 5 (LCI-5) and SIGAM Score) was collected at six weeks, six months and twelve months after delivery of prosthesis to the client.
RESULTS:
Fifty-six percent of participants who completed the 12 month post rehabilitation assessment (n = 68) achieved mobility success. (success was defined as returning to or exceeding baseline mobility scores on the SIGAM for those scoring C-F, and for those who scored A or B at baseline, moving up one category (i.e. going from A to B, or B to C). The pre-rehabilitation SIGAM score was used as a predictor of the IPLLAs expected mobility outcome. There was a highly significant correlation between pre-rehabilitation and 12 month post-rehabilitation SIGAM scores, (r = 0.89, n = 68, p < 0.001) demonstrating that the MDT’s predictions significantly correlated to the post-rehabilitation SIGAM scores. There was a highly significant association between pre-amputation mobility levels and mobility success post-rehabilitation at 12 month follow-up (χ2 (3) = 26.43, p < 0.001), such that those who were ambulatory independently pre-amputation were significantly more likely to achieve mobility success post-rehabilitation.
CONCLUSION:
IPLLAs attending an outpatient rehabilitation service can achieve successful mobility outcomes. The MDT was found to be accurate in its predictions of mobility outcome in this cohort. Greater pre-amputation mobility was significantly associated with successful mobility outcomes.
Introduction
Internationally, there is an age-related increase in lower limb amputation (LLA) secondary to dysvascular disease [1]. Research demonstrates that most IPLLAs in the developed world are dysvascular patients aged over 60 years and often present with diabetes mellitus (DM) [2, 3] or other systematic comorbidities, such as cardiovascular disease or end-stage renal disease [4]. Additionally, the mortality rates after amputation are high, ranging from 15 to 30% one month after amputation [5, 6], above 50 % after one year [6], and may reach up to 74% after 5 years [7]. In general, for those with atraumatic causes of amputation there is a decline in health status following discharge and 5-year mortality as high as 77% [8–10] Therefore, as the population of Ireland ages, there will be increased morbidity and mortality rates as a result of amputation.
It must be noted that older dysvascular persons with LLA often present with numerous physical, psychological, cognitive and social comorbidities, which presents several rehabilitation challenges to the MDT [4]. Furthermore, rehabilitation in this cohort is further complicated by deconditioning because of natural ageing in addition to that from post-operative immobilisation. Therefore, it is clear that older people with LLA are a growing cohort in Ireland requiring rehabilitation and thus will continue to require a significant amount of public health resources.
Despite advances in medicine and the emphasis on disease prevention, amputations are prevalent worldwide [11]. In Ireland, there are over 4,000 people living with an amputation [12]. The ultimate goals of rehabilitation programs for people with amputation(s) are improvement of mobility and reintegration in the community [13] but this is often not achieved. People with amputation(s) in Ireland requiring prosthetic rehabilitation traditionally attended the National Rehabilitation Hospital (NRH), Dublin, for inpatient prosthetic rehabilitation. However, this model is more costly than outpatient rehabilitation [14]. Additionally, patients from all over the Republic of Ireland had to travel to Dublin and spend extended periods away from the community into which they were being reintegrated. With this in mind, the Prosthetic Orthotic and Limb Absence Rehabilitation (POLAR) Unit was established in The Mercy University Hospital (MUH), Cork in 2011.
The POLAR Unit is the regional specialist prosthetic rehabilitation service for Cork and Kerry. It is the only centre in the Republic of Ireland that specialises in outpatient, interdisciplinary limb absence rehabilitation for IPPLAs. The interdisciplinary team includes the Consultant in Rehabilitation, Senior Physiotherapist and Occupational Therapist, Nurse Specialist and Senior Prosthetist.
Current literature
The effect of the rehabilitation environment for IPPLAs has only recently been investigated [15]. Research has shown that people with dysvascular amputation who received post-acute care in an inpatient rehabilitation facility experience better outcomes six months post amputation than those who were treated in a skilled nursing facility or discharged directly home [16]. Dillingham et al. [17] reported reduced mortality, lower rates of re-amputation, greater medical stability and improved prosthesis acquisition following inpatient rehabilitation. While the literature suggests that inpatient prosthetic rehabilitation is preferable, research regarding the mobility success for people with amputation attending a specialist outpatient service is lacking.
The MDT approach to rehabilitation for people with amputation is recognised internationally as the rehabilitation model of choice [18]. However, there is little published literature to support it. Two case-control studies [19, 20] suggested that people with vascular amputation(s) benefit from care by a specialist MDT with reduced hospital stay, reduced out-patient re-attendance and increased use of the prosthesis.
Taylor et al. [21] found that IPLLAs were ten times less likely to use their prosthesis if they were non-ambulatory preoperatively, three times less likely if homebound, 2.7 times less likely if older than 60 and twice less likely if suffering from coronary artery disease. However, the effects of the MDT and pre-amputation mobility have been examined in the inpatient setting and therefore, similar research in the outpatient setting is indicated. Therefore, mobility outcomes of IPLLAs attending the POLAR Unit must be examined to determine if outpatient rehabilitation is successful for this cohort.
Thus, the aims of this study are; To determine if IPLLAs attending the POLAR Unit return to or exceed pre-amputation mobility levels. To examine the MDT’s ability to accurately predict if IPLLAs attending the POLAR Unit return to or exceed pre-amputation mobility levels. To evaluate how pre-amputation mobility levels affect IPLLA’s ability to return to or exceed pre-amputation mobility levels.
Materials and methods
Participants
All people with primary (new) amputation(s) who attended the MDT Assessment Clinic at the POLAR Unit between August 2011 and February 2015, whose cause of amputation was complications of peripheral vascular disease (PVD), diabetes, malignancy or trauma were included. This included people with unilateral and bilateral amputations at or proximal to the transtibial level. People with congenital, upper limb or established amputations were excluded.
Measurements
Locomotor Capabilities Index-5 (LCI-5)
The LCI-5 measures a LLA’s locomotor capabilities with a prosthesis during and after rehabilitation [22]. It consists of 14 items graded on a five-level ordinal scale ranging from unable to perform the activity, to able to perform alone without aids [23]. It has well-established internal consistency, test-retest reliability, and validity [24]. Scores for the LCI-5 range from 0 to 56 with higher scores representing higher function.
Specialist Interest Group in Amputee Medicine (SIGAM) scale
The SIGAM scale measures function of IPPLAs fitted with a prosthesis in terms of mobility. It includes a benchmark distance of 50 metres to assign the grading. It is responsive to change in mobility during the first 6 months after amputation [25], has construct and criterion validity, and it is recommended for routine clinical practice [26]. It has a reported test-retest reliability of 0.79 and its validity was established by demonstration of association with the timed walking test [25].
Timed Walk Tests (TWT)
The 10 m timed walking test is reliable, valid, sensitive and relevant [27]. It assesses the time needed by patients to walk 10 m on level ground in a straight line, using their own walking aid, if any, at their preferred speed [28].
Pre-amputation mobility
Pre-amputation mobility status was characterized as per Taylor et al. [21]; Ambulatory (independent ambulation out of house). Ambulatory/homebound (ambulatory in the home only). Nonambulatory/transfer. Nonambulatory/bedridden.
The author posed the question; ‘In the three months before your amputation, how far could you walk?’ Milestones such as Christmas, birthdays or other medical interventions were used to improve accuracy of recall and all answers were verified with the patient’s accompanying carer at the time of the assessment.
Procedure
This was a retrospective observational cohort study. Ethical approval was obtained from the Clinical Research Ethics Committee of the Cork Teaching Hospitals. All information was anonymized and stored confidentially in accordance with current hospital policy. Routine data were collected from the client’s medical records using Microsoft EXCEL.
Between one and six weeks after amputation, the IPLLAs attended the POLAR Unit for their pre-rehabilitation assessment. At this point, Pre-Amputation Mobility Status and SIGAM Score were recorded. The SIGAM Score was used as a predictor of the client’s expected post-rehabilitation mobility.
Six weeks after delivery of their prosthesis, the TWT was assessed and data collected.
Six months after delivery of their prosthesis, the TWT and the LCI-5 were assessed.
Twelve months after delivery of their prosthesis, the TWT, the LCI-5 and SIGAM were assessed.
Mobility success was defined as returning to or exceeding baseline mobility scores on the SIGAM for those scoring C-F, and for those who scored A or B at baseline, moving up one category i.e. going from A to B, or B to C.
Data analysis
Statistical analysis was carried out using the Statistical Package for the Social Sciences (SPSS) version 20.0. Statistical significance is assumed when p < 0.05. As the assumption of normality was violated, non-parametric tests were employed, and median/interquartile ranges reported when describing the distribution of the data. The Spearman’s Rho (r) correlation coefficient was used to assess bivariate relationships between continuous variables. Pearson’s Chi-square statistic is a non-parametric test which was used here to analyse group differences between nominal and ordinal variables. The Wilcoxon signed-rank test is the nonparametric test equivalent to the dependent t-test and was used to investigate changes in continuous scores from one time point to another.
Results
Three hundred and forty four IPLLAs were referred to the POLAR Unit between August 2011 and Feb 2015. Ninety-three IPLLAs who attended the CPAC in this time met the inclusion criteria. Data from all these participants were included in this study and are presented in Table 1. Seventy- three males (78.5%) and twenty females (21.5%) were included. The median age of participants was 70 years (IRQ 19.75), with a minimum age of 30 and a maximum of 89.
Baseline Participant Data
Baseline Participant Data
Abbreviations: PVD: Peripheral Vascular Disease; DM: Diabetes Mellitus; CUH: Cork University Hospital; MUH: Mercy University Hospital; KGH: Kerry General Hospital.
Eight participants died before their 6-month assessment and two participants died after their six-month assessment but before their 12-month assessment. Additionally, participants recruited after February 2014 or August 2014 would not have reached their 12 or 6-month assessment respectively at the time of analysis. Therefore, 52 participants completed the TWT at the 6-week assessment. Forty-six participants completed the TWT and the LCI-5 at the 6-month assessment. Finally, 38 participants completed the TWT and LCI-5 at the 12-month assessment (Table 2).
Timed Walk Test and Locomotor Capabilities Index-5 Tests after prosthesis delivery
Abbreviations: TWT: Timed Walk Test; LCI-5: Locomotor Capabilities Index-5; Min: Minimums; Max: Maximums; IQR: Interquartile Range.
For the purposes of this study, mobility success post-rehabilitation was defined as returning to or exceeding baseline mobility scores on the SIGAM for those scoring C-F, and for those who scored A or B at baseline, moving up one category i.e. going from A to B, or B to C. This definition was chosen because it is the improvement in function relative to baseline functional status that is critical in this cohort [29]. Fifty-six percent of participants (n = 68) achieved mobility success and forty-four percent did not.
Mobility outcomes after prosthesis delivery
The median time taken to cover 10 m improved from 17.6 seconds at 6 weeks post-delivery of prosthesis to a median time of 9.7 seconds. A Wilcoxon Signed-Rank test revealed a statistically significant difference between the TWT at 6 weeks post-delivery of prosthesis and TWT at 12 months post-delivery (z = –5.23, p < 0.001).
The median basic LCI-5 scores improved from 22 at 6 months to a median of 24.0 at 12 months. A Wilcoxon Signed-Rank test revealed a statistically significant difference between the basic LCI-5 scores at 6 and 12 months (p < 0.001). The median advanced LCI-5 scores at 6 months improved from 16 to 21 at 12 months. A statistically significant difference was also found between advanced LCI-5 scores at 6 and 12 months (p < 0.001).
Correlations between pre-rehabilitation SIGAM scores post-rehabilitation LCI-5 and TWT scores
This correlation was examined to assess the MDT’s ability to accurately predict if IPLLAs attending the POLAR Unit return to or exceed pre-amputation mobility levels.
There was a significant relationship between pre-rehabilitation SIGAM scores and 6 and 12 month follow-up LCI-5 and TWT. See Tables 3 and 4.
Correlations between Pre-Rehabilitation Predicted Specialist Interest in Amputee Medicine (SIGAM) scores and 6 month Timed Walk Test and Locomotor Capabilities Index-5 scores
Correlations between Pre-Rehabilitation Predicted Specialist Interest in Amputee Medicine (SIGAM) scores and 6 month Timed Walk Test and Locomotor Capabilities Index-5 scores
Abbreviations: LCI-5: Locomotor Capabilities Index-5; SIGAM: Specialist Interest Group in Amputee Medicine; TWT: Timed Walk Test. **p < 0.01.
Correlations between the Pre-Rehabilitation Predicted Specialist Interest in Amputee Medicine (SIGAM) scores and the 12 month Locomotor Capabilities Index-5 scores and Timed Walk Test
Abbreviations: LCI-5: Locomotor Capabilities Index-5; SIGAM: Specialist Interest Group in Amputee Medicine; TWT: Timed Walk Test. **p < 0.01.
Baseline SIGAM Scores were recorded, SIGAM 12-month follow-up scores were recorded and then the results were compared (Table 5). The relationship between pre-rehabilitation SIGAM scores and 12 month follow-up SIGAM scores was assessed using a Spearman’s Rho correlation coefficient; there was a highly significant correlation between pre and post rehab scores (r = 0.89, n = 68, p < 0.001).
Baseline Specialist Interest Group in Amputee Medicine (SIGAM) Scores at CPAC compared to SIGAM Scores at 12-month follow-up
Baseline Specialist Interest Group in Amputee Medicine (SIGAM) Scores at CPAC compared to SIGAM Scores at 12-month follow-up
Abbreviations: SIGAM: Specialist Interest Group in Amputee Medicine.
The data for the two participants that died after their six-month assessment but before their twelve-month assessment was missing (Table 6).
Twelve Month Follow-Up Specialist Interest Group in Amputee Medicine (SIGAM) Scores Analysed by Baseline SIGAM Scores (N= 93)
Abbreviations: SIGAM: Specialist Interest Group in Amputee Medicine.
As per Taylor et al. [21], pre-amputation mobility was characterised using four categories. This demonstrated that pre-operatively, the largest category of participants (35.1%) were independent ambulators outside of the house while 30.8% ambulated only in their home. Nearly nineteen percent had limited home-based ambulation and therefore, could transfer from the bed to the chair or from chair to the commode, while 15.4% were non-ambulatory or bedridden pre-amputation (Table 7).
Pre-amputation Mobility Levels
Pre-amputation Mobility Levels
Mobility success was determined by examining the LCI-5, TWT and SIGAM Score. There was a highly significant association between pre-amputation mobility levels and mobility success post-rehabilitation at 12 month follow-up χ2 (3) = 26.43, p < 0.001.
Mobility has been one of the key outcomes used to quantify functional improvement after amputation. Kent and Fyfe [29] found that it is the improvement in function relative to baseline functional status that is critical.
In the present study, 56% of participants who were re-assessed 12 months after prosthesis delivery (n = 68) achieved mobility success post-rehabilitation. This is a positive finding when compared to other similar cohorts such as Czerniecki et al. [15]. These author’s cohort was very similar to the present study as it was a group of older (median age 62 years), mainly TTAs (60%) whose primary cause of LLA was PVD and or DM. However, unlike the present study, Czerniecki et al. [15] studied inpatients with amputations.
It is important to note that in the present research, some participants had not yet reached their 6 or 12-month assessment by the time data collection was completed, and thus there was full data for both pre and post-rehabilitation SIGAM scores for only 68 participants. Considering that higher amputation level is associated with poorer mobility outcome [30], and that the present study is based mainly on people with dysvascular amputation(s) with higher amputation levels, the results of the present study compare very favourably with other research.
Effect of rehabilitation environment on mobility outcome
There was a statistically significant positive difference between the TWT at 6 and 12 months post-delivery. Furthermore, there was a statistically significant positive difference between the basic LCI-5 scores at 6 and 12 months and a statistically significant positive difference was also found between advanced LCI-5 scores at 6 and 12 months. This demonstrates that these mobility outcomes improved significantly over time, suggesting that people with primary amputation(s) attending the POLAR Unit achieved successful mobility outcomes.
Czerniecki et al. [15] found that those who were treated in a comprehensive inpatient rehabilitation unit (CIRU) were 17% more likely to achieve mobility success that those who never attended, controlling for a myriad of important confounding factors. These authors found that within the literature on stroke rehabilitation, there is evidence that one such factor for success may be the interdisciplinary coordination found in the inpatient unit. According to these authors, existing data have shown that teams with better structure and organization for treatment planning and communication provide better outcomes. Therefore, considering the POLAR Unit is a specialised MDT with regular structured goal-setting meetings as well as clear communication pathways, it is reasonable to suggest that it can continue to offer successful prosthetic rehabilitation.
The MDT’s ability to predict mobility outcomes
Accurate prediction of mobility outcome is essential as it helps to determine a patient’s suitability for prosthetic rehabilitation, goal setting, prosthesis prescription and may influence discharge destination.
There was a highly significant correlation between pre-rehabilitation and 12 month post-rehabilitation SIGAM scores. This demonstrates that the MDT’s predictions significantly correlated to the post-rehabilitation SIGAM scores. This result reinforces the importance of the MDT in both the pre- and post-rehabilitation phases, and adds to the limited literature on the benefits of specialist MDT input in this cohort.
Of note, the participants who were predicted to be SIGAM A (non-limb user), E (Independent) or F (Normal), were accurately predicted by the MDT 100% of the time. Of the 21 participants that were predicted to be SIGAM C (Limited/Restricted) prosthetic limb users, the MDT was accurate with the majority (81%) of these predictions.
Interestingly, for the people with amputation(s) that the MDT predicted to be SIGAM D (Impaired) prosthetic users, just over half (55.6%) of these predictions were accurate at the 12 month follow-up, and thus were SIGAM D prosthetic users. Just over 22.2% achieved a lower mobility level and 22.2% achieved greater mobility than predicted by the MDT. This outcome is interesting as it highlights the challenges of accurately predicting mobility outcomes amongst people with amputation(s) who mobilise in a ‘limited’ or ‘impaired’ capacity. It is often more straightforward to identify people with amputation(s) who will clearly not be prosthetic mobilisers (SIGAM A or B) or those who will clearly be ‘independent’ or ‘normal’ prosthetic mobilisers. Therefore, further dialogue amongst MDT members may be required to more accurately predict mobility outcomes amongst people with amputation(s) who mobilise in a ‘limited’ or ‘impaired’ capacity.
Pre-amputation mobility
According to Sansam et al. [30], pre-operative walking status is positively predictive of walking ability after rehabilitation. However, post-operative motor function is not. This may be due to transient impairment of mobility by post-operative complications such as swelling and wound healing in this early period, which have a lesser impact on eventual mobility.
With this in mind, Taylor et al. [21] categories were used to compare pre-amputation and post-rehabilitation mobility at 12 months. There was a highly significant association between pre-amputation mobility levels and mobility success post-rehabilitation at 12 month follow-up, such that those who were ambulatory independently pre-amputation were significantly more likely to achieve mobility success post-rehabilitation, than those who were non-ambulatory pre-amputation. Specialist Physiotherapy input is recommended [18], to ensure pre-amputation mobility is correctly assessed, thus ensuring accurate prediction of prosthetic mobility and prosthetic prescription pre- and post-amputation. Physiotherapy input is essential to ensure each person with an amputation is prescribed the correct prosthesis, achieves optimal mobility and therefore community re-integration.
Limitations
This was an observational study. The participants receiving their rehabilitation as outpatients were not randomised or compared to people with amputation(s) in any other rehabilitation environment or control group. This is an area requiring further research in future.
The LCI-5 was collected through interview and therefore may be subject to the limitations of self-reporting. However, concerns about this issue are at least somewhat alleviated by the strong psychometric properties of the LCI-5, and a firm movement towards patient reported outcomes for outcomes research. Furthermore, recall bias was minimised by checking data with the participant’s accompanying family member.
While the sample size included the entire number of people with primary amputation(s) attending this service within the study timeframe, it was limited to 93 participants.
Conclusion
This study is the first of its kind as it examines a unique rehabilitation service for people with amputation(s). It demonstrates that older people with amputation(s) attending an outpatient rehabilitation service can achieve successful mobility outcomes. However, research comparing the mobility outcomes of this unique outpatient rehabilitation unit and other rehabilitation settings is essential to determine if we, as healthcare providers are achieving optimal outcomes for this vulnerable cohort of older people.
The MDT was found to be accurate in its predictions of mobility outcome in this cohort. This is an important finding as accurate prediction allows the person with an amputation(s) and their family to plan any future environmental requirements in the home or workplace. Furthermore, this result reinforces the importance of access to a specialist MDT for all people with primary amputation(s).
This study found that greater pre-amputation mobility was significantly associated with successful mobility outcomes. Therefore, pre-amputation mobility levels must be considered before offering someone with an amputation prosthetic rehabilitation.
This research provides a significant contribution to the existing literature, which is essentially confined to the inpatient rehabilitation setting. It further adds to the very limited amount of data available on people with amputation(s) in Ireland and particularly those receiving rehabilitation outside of the NRH.
Conflict of interest
There is no financial interest or conflict of interest.
Footnotes
Acknowledgments
I would like to thank all the participants and staff who supported me throughout the research process.
