Measures and procedures utilized to determine the added value of microprocessor-controlled prosthetic knee joints: a systematic review.

BACKGROUND: The effectiveness of microprocessor-controlled prosthetic knee joints (MPKs) has been assessed using a variety of outcome measures in a variety of health and health-related domains. However, if the patient is to receive a prosthetic knee joint that enables him to function optimally in daily life, it is vital that the clinician has adequate information about the effects of that particular component on all aspects of persons' functioning. Especially information concerning activities and participation is of high importance, as this component of functioning closely describes the person's ability to function with the prosthesis in daily life. The present study aimed to review the outcome measures that have been utilized to assess the effects of microprocessor-controlled prosthetic knee joints (MPK), in comparison with mechanically controlled prosthetic knee joints, and aimed to classify these measures according to the components and categories of functioning defined by the International Classification of Functioning, Disability and Health (ICF). Subsequently, the gaps in the scientific evidence regarding the effectiveness of MPKs were determined. METHODS: A systematic literature search in 6 databases (i.e. PubMed, CINAHL, Cochrane Library, Embase, Medline and PsychInfo) identified scientific studies that compared the effects of using MPKs with mechanically controlled prosthetic knee joints on persons' functioning. The outcome measures that have been utilized in those studies were extracted and categorized according to the ICF framework. Also, a descriptive analysis regarding all studies has been performed. RESULTS: A total of 37 studies and 72 outcome measures have been identified. The majority (67%) of the outcome measures that described the effects of using an MPK on persons' actual performance with the prosthesis covered the ICF body functions component. Only 31% of the measures on persons' actual performance investigated how an MPK may affect performance in daily life. Research also typically focused on young, fit and active persons. CONCLUSIONS: Scientifically valid evidence regarding the performance of persons with an MPK in everyday life is limited. Future research should specifically focus on activities and participation to increase the understanding of the possible functional added value of MPKs.

A microprocessor stance and swing control orthosis improves balance, risk of falling, mobility, function, and quality of life of individuals dependent on a knee-ankle-foot orthosis for ambulation.

INTRODUCTION: The C-Brace microprocessor stance and swing control orthosis was designed to overcome safety and functional limitations of traditional knee-ankle-foot orthoses (KAFOs) for individuals with lower limb paresis. However, a systematic comparison to established KAFO types has not been performed in a bigger sample. METHODS: International multicenter, randomized, controlled, cross-over clinical trial. Legacy KAFO users at risk of falling were randomized to KAFO/C-Brace or C-Brace/KAFO use for three months with each orthosis. Primary outcome was balance assessed with the Berg Balance Scale (BBS). Secondary outcomes were falls, mobility, function, and quality of life. RESULTS: Intention-to-treat analysis with 102 participants. With the C-Brace, the BBS improved by 3.3 ± 6.3 points (p < 0.0001). Significantly fewer participants presented BBS scores <40 indicative of increased fall risk (16 vs. 36, p = 0.018). Mean falls reduced from 4.0 ± 16.8 to 1.1 ± 3.3 (p = 0.002). Outcomes for function, mobility, and quality of life showed significant improvements with the C-Brace. DISCUSSION: The improvements in fall risk and mobility can be attributed to the stumble recovery and controlled knee flexion during weight bearing of the C-Brace and have a positive impact on the quality of life of users. CONCLUSION: The C-Brace represents an option for KAFO users with increased fall risk and reduced mobility.

When prescribing traditional knee-ankle-foot orthoses (KAFOs), their known limitations, such as limited function and mobility, and the requirement to walk with compensatory mechanisms, especially on non-level terrains, should be considered.For patients with compromised balance and increased risk of falling when using a traditional KAFO, a microprocessor stance and swing control orthosis (MP-SSCO) may be considered as an orthotic option to reduce their fall risk.For patients with mobility restrictions using a traditional KAFO, a MP-SSCO may be considered to improve function, mobility, reintegration into normal living, and quality of life.

Cost-effectiveness of an integrated 'fast track' rehabilitation service for multi-trauma patients: A non-randomized clinical trial in the Netherlands.

BACKGROUND: Multidisciplinary rehabilitation has been recommended for multi-trauma patients, but there is only low-quality evidence to support its use with these patients. This study examined whether a Supported Fast track multi-Trauma Rehabilitation Service (Fast Track) was cost-effective compared to conventional trauma rehabilitation service (Care As Usual) in patients with multi-trauma from a societal perspective with a one-year follow-up. METHODS: An economic evaluation alongside a prospective, multi-center, non-randomized, controlled clinical study, was conducted in the Netherlands. The primary outcome measure was the Functional Independence Measure (FIM). Generic Quality of Life and Quality Adjusted Life Years (QALYs) of the patients were derived using the Short-form 36 Health Status Questionnaire. Incremental Cost-Effectiveness Ratios (ICERs) were stated in terms of costs per unit of FIM improvement and costs per QALY. To investigate the uncertainty around the ICERs, non-parametric bootstrapping was used. RESULTS: In total, 132 patients participated, 65 Fast Track patients and 67 Care As Usual patients. Mean total costs per person were €18,918 higher in the Fast Track group than in the Care As Usual group. Average incremental effects on the FIM were 3.7 points (in favor of the Fast Track group) and the incremental (extra) bootstrapped costs were €19,033, resulting in an ICER for cost per FIM improvement of €5,177. Care As Usual dominated Fast Track in cost per QALY as it gave both higher QALYs and lower costs. All sensitivity analyses attested to the robustness of our results. CONCLUSIONS: This study demonstrated that a multidisciplinary rehabilitation program for multi-trauma patients according to the supported fast track principle is promising but cost-effectiveness evidence remains inconclusive. In terms of functional outcome, Fast Track was more expensive but yielded also more effects compared to the Care As Usual group. Looking at the costs per QALYs, unfavorable ICERs were found. Given the lack of a willingness-to-pay threshold for functional recovery and the relatively short time horizon, it is not possible to draw firm conclusions about the first. TRIAL REGISTRATION: (Current Controlled Trials register: ISRCTN68246661).

The Magnitude and Time Course of Muscle Cross-section Decrease in Intensive Care Unit Patients.

OBJECTIVE: Bedriddenness and immobilization of patients at an intensive care unit may result in muscle atrophy and devaluation in quality of life. The exact effect of immobilization on intensive care unit patients is not known. The aim of this study was to investigate the magnitude and time course of muscle cross-section decrease in acute critically ill patients admitted to the intensive care unit. DESIGN: An observational pilot study was performed in intensive care unit patients. Data of bilateral ultrasound muscle cross-section measurements of the knee extensors and the elbow flexors were collected. Thirty-four intensive care unit patients were included in this study; data are presented from 14 patients who were measured at least three times. RESULTS: Repeated measures analysis of variance shows a significant decrease in muscle cross-section over time (F1,13 = 80.40, P ≤ 0.001).The decrease in muscle cross-section of the arms was significantly higher (F1,13 = 5.38, P = 0.037) than the decrease of the legs. Four weeks after intensive care unit admission, the muscle cross-section decrease had not reached an asymptote yet. CONCLUSIONS: The muscle cross-section decrease in bedridden intensive care unit patients is significant for a time of 2 to 4 weeks. The decrease in muscle cross-section of the arms is greater than the decrease of the legs.

Effects of an Integrated 'Fast Track' Rehabilitation Service for Multi-Trauma Patients: A Non-Randomized Clinical Trial in the Netherlands.

OBJECTIVES: The effects on health related outcomes of a newly-developed rehabilitation program, called 'supported Fast Track multi-trauma rehabilitation service' (Fast Track), were evaluated in comparison with conventional trauma rehabilitation service (Care as Usual). METHODS: Prospective, multi-center, non-randomized controlled study. Between 2009 and 2012, 132 adult multi-trauma patients were included: 65 Fast Track and 67 Care as Usual patients with an Injury Severity Score ≥16, complex multiple injuries in several extremities or complex pelvic and/or acetabulum fractures. The Fast Track program involved: integrated coordination between trauma surgeon and rehabilitation physician, shorter stay in hospital with faster transfer to a specialized trauma rehabilitation unit, earlier start of multidisciplinary treatment and 'non-weight bearing' mobilization. Primary outcomes were functional status (FIM) and quality of life (SF-36) measured through questionnaires at baseline, 3, 6, 9 and 12 months post-trauma. Outcomes were analyzed using a linear mixed-effects regression model. RESULTS: The FIM scores significantly increased between 0 and 3 months (p<0.001) for both groups showing that they had improved overall, and continued to improve between 3 and 6 months for Fast Track (p = 0.04) and between 3 and 9 months for Care as Usual (p = 0.03). SF-36 scores significantly improved in both groups between 3 and 6 months (Fast Track, p<0.001; Care as Usual, p = 0.01). At 12 months, SF-36 scores were still below (self-reported) baseline measurements of patient health prior to the accident. However, the FIM and SF-36 scores differed little between the groups at any of the measured time points. CONCLUSION: Both Fast Track and Care as Usual rehabilitation programs were effective in that multi-trauma patients improved their functional status and quality of life. A faster (maximum) recovery in functional status was observed for Fast Track at 6 months compared to 9 months for Care as Usual. At twelve months follow-up no differential effects between treatment conditions were found. TRIAL REGISTRATION: ISRCTN68246661.

Influence of advanced prosthetic knee joints on perceived performance and everyday life activity level of low-functional persons with a transfemoral amputation or knee disarticulation.

OBJECTIVE: To assess the effects of two types of microprocessor-controlled prosthetic knee joints (MPKs) on perceived performance and everyday life activity level. DESIGN: Randomized cross-over trial. SUBJECTS: Thirty persons with a unilateral above-knee amputation or knee disarticulation classified as Medicare Functional Classification Level-2. METHODS: Participants were measured in 3 conditions, i.e. using a mechanically controlled prosthesis, an MPK featuring a microprocessor-controlled stance and swing phase (MPKA), and an MPK featuring a microprocessor-controlled stance phase (MPKB). Subjects' perceived performance regarding prosthesis use was measured with the Prosthesis Evaluation Questionnaire. Subjects' activity level was quantified using accelerometry. As high within-group variability regarding subjects' functional performance was expected to impede detection of possible effects of an MPK, data were analysed for the total group and for 3 subgroups of participants. RESULTS: Participants' perception regarding ambulation, residual limb health, utility, and satisfaction with walking were significantly higher in the MPKA condition compared with the mechanical knee joint condition. Participants' activity level was similar in all knee joint conditions. CONCLUSION: Although Medicare Functional Classification Level-2 amputees report benefitting in terms of their performance from using an MPK, this is not reflected in their actual daily activity level after one week of using an MPK.

Functional added value of microprocessor-controlled knee joints in daily life performance of Medicare Functional Classification Level-2 amputees.

OBJECTIVE: To assess the effects of using a microprocessor-controlled prosthetic knee joint on the functional performance of activities of daily living in persons with an above-knee leg amputation. OBJECTIVE: To assess the effects of using a microprocessor-controlled prosthetic knee joint on the functional performance of activities of daily living in persons with an above-knee leg amputation. DESIGN: Randomised cross-over trial. SUBJECTS: Forty-one persons with unilateral above-knee or knee disarticulation limb loss, classified as Medicare Functional Classification Level-2 (MFCL-2). METHODS: Participants were measured in 3 conditions, i.e. using a mechanically controlled knee joint and two types of microprocessor-controlled prosthetic knee joints. Functional performance level was assessed using a test in which participants performed 17 simulated activities of daily living (Assessment of Daily Activity Performance in Transfemoral amputees test). Performance time was measured and self-perceived level of difficulty was scored on a visual analogue scale for each activity. RESULTS: High levels of within-group variability in functional performance obscured detection of any effects of using a microprocessor-controlled prosthetic knee joint. Data analysis after stratification of the participants into 3 subgroups, i.e. participants with a "low", "intermediate" and "high" functional mobility level, showed that the two higher functional subgroups performed significantly faster using microprocessor-controlled prosthetic knee joints. CONCLUSION: MFCL-2 amputees constitute a heterogeneous patient group with large variation in functional performance levels. A substantial part of this group seems to benefit from using a microprocessor-controlled prosthetic knee joint when performing activities of daily living.

Feasibility of a new concept for measuring actual functional performance in daily life of transfemoral amputees.

OBJECTIVE: Determining the feasibility of implementing a new concept to objectively evaluate actual functional abilities of transfemoral amputees into a new measuring tool called "Assessment of Daily Activity Performance in Transfemoral amputees" (ADAPT). DESIGN: Study 1: cross-sectional design. Study 2: repeated measures design. SUBJECTS: Study 1 comprised two groups of 10 participants, age range 19-72 years. One group used microprocessor-controlled knee joints and the other group used mechanically controlled knee joints. Study 2 comprised 20 participants, age range 31-68 years. METHODS: Two versions of ADAPT were assessed in the separate studies. In study 1 performance times on version 1 of ADAPT were compared between groups. In study 2 participants completed version 2 of ADAPT twice with a 1 h rest between trials. The Locomotor Capabilities Index was administered. Reliability was determined by calculating correlation coefficients and by Bland-Altman analyses. RESULTS: In study 1, ADAPT version 1 proved to be sensitive in detecting differences in performance between groups. In study 2, 75% of all correlation coefficients exceeded 0.90 in version 2 of ADAPT. Bland-Altman analyses showed high test-retest agreement. CONCLUSION: It is feasible to reliably assess actual functional abilities of transfemoral amputees using standardized simulations of daily activities. This ADAPT concept is able to differentiate between different functional performance levels.