Validity and Reliability of the German Version of the Locomotor Capabilities Index-5 (LCI-5).

BACKGROUND: Before foreign language questionnaires, such as patient reported outcome measures (PROMs), can be scientifically used in the national language, guideline-based translation, cultural adaptation and comprehensive verification of their validity and reliability are needed. The aim of this study was to assess the psychometric properties of the German version of the LCI-5 (LCI-5-D) on a sample of people with lower limb amputation (LLA). METHODS: The LCI-5 was translated into German (LCI-5-D) based on the ISPOR guidelines for cross-cultural adaptation following pilot testing. The final LCI-5-D was administered to n = 52 lower limb amputees in order to determine the validity and reliability of both the total score and the subscores ("basic items" and "advanced items"). Internal consistency (Cronbach's alpha), test-retest reliability (ICC2,1), standard error of the mean (SEM), minimal detectable change (MDC), item-to-total correlation, and item-to-subscale correlation were calculated. Floor and ceiling effects were checked. For construct validity, the Rivermead Mobility Index (RMI) and timed up and go (TUG) test were correlated, and differences of defined subgroups (amputation height and prosthesis user type) were calculated. RESULTS: On average, the score of the LCI-5-D was 40.13 ± 16.64 points. High ceiling effects were present for the subscale "basic items" (57.7% maximum score). Internal consistency showed excellent results (Cronbach's α = 0.97). A strong correlation to the RMI (r = 0.863; p < 0.001) and to the TUG (r = - 0.714; p < 0.001) demonstrated construct validity. Test-rest reliability was measured after an averaged time span of 5.3 ± 2.47 days and resulted in very high reliability [ICC (2,1) = 0.97; p < 0.001]. MDC was 7.57 points for the total score. CONCLUSION: The LCI-5-D is a valid and reliable PROM for measuring mobility with prostheses in German-speaking lower limb amputees, which is rather suitable for people with low to moderate mobility abilities. It can be used in a German-speaking population.

[Translation, Adaptation, Reliability and Validity of the German Version of the Prosthesis Mobility Questionnaire 2.0 (PMQ) on Patients with Major Lower Limb Amputation]. / Übersetzung und transkulturelle Adaptation des Prosthesis Mobility Questionnaire 2.0 (PMQ) ins Deutsche und dessen Reliabilität und Validität bei Patienten mit Majoramputation der unteren Extremität.

PURPOSE: The aim of this prospective validation study was to translate the Prosthesis Mobility Questionnaire 2.0 (PMQ) into German based on a guideline, following by psychometric testing for its validity and reliability using classical test theory. METHODS: The PMQ was translated into German according to ISPOR guidelines using double forward and double backward translations, finalized by pilot testing (N=10). Subsequently, assessment of the validity and reliability was performed from March 2020 to August 2020 on N=61 patients with unilateral lower limb amputation. Construct validity was determined by using the German version of the Locomotor Capabilities Index-5 (LCI-5-D), the Rivermead Mobility Index (RMI), the Timed up and go Test (TUG), and K-levels. Cronbach's alpha was calculated to check internal consistency and discriminatory power was determined by item correlations. Test-retest reliability was calculated using ICC (2,1). Based on the ICC, the minimum detectable difference (MDC) was calculated. RESULTS: The translation process required small changes after the pilot test. The validation study was performed on N=61 patients (56.59±13.16 years, m/f=38/23). A mean PMQ of 26.23±8.89 points was achieved. Ceilings or floor effects for total score did not appear. Construct validity showed strong positive correlations to LCI-5-D (r=0.74, p<0.001), RMI (r=0.63 p<0.001) as well as k-levels (r=0.61 p<0.001) and moderate negative correlation to TUG (r=- 0.49, p<0.001). Internal consistency was excellent with Cronbach's alpha=0.95). All items showed a value greater than r=0.40 for item-to-total score correlation. Test-retest reliability was excellent with an ICC (2,1)=0.98 with a timespan between T0 and T1 of 3.2±2.83 days. Based on this results, the MDC was 3.40 points. CONCLUSION: The German version of the Prosthesis Mobility Questionnaire 2.0 is a valid, reliable patient reported outcome measure (PROM) for measuring mobility and functional ability of patients with exoprosthesis due to unilateral lower limb amputation. It can be used for a German-speaking population.

The effects of whole-body electromyostimulation (WB-EMS) in comparison to a multimodal treatment concept in patients with non-specific chronic back pain-A prospective clinical intervention study.

BACKGROUND: According to present guidelines, active exercise is one key component in the comprehensive treatment of nonspecific chronic back pain (NSCBP). Whole body electromyostimulation (WB-EMS) is a safe, and time-effective training method, that may be effective in NSCBP-patients. METHODS: In this prospective and controlled nonrandomized clinical study, two therapeutic approaches were compared. One group received 20 minutes WB-EMS per week. An active control group (ACG) received a multimodal therapy program. A third group included subjects without back pain. To all groups, the following measurement instruments were applied: Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), North American Spine Society Instrument (NASS); SF 36 survey and measurements for muscular function and postural stability. In the EMS-group: T0: baseline; T1: at 6 weeks; T2: at 12 weeks and T3: at 24 weeks. In the ACG: T0 baseline and T1 after 4 weeks. RESULTS: In the intervention group, 128 patients with low back pain were enrolled, 85 in the WB-EMS group and 43 in the ACG. 34 subjects were allocated to the passive control group. The average age was 58.6 years (18-86 years). In the EMS group, the NRS (1-10) improved statistically and clinically significantly by 2 points. The ODI was reduced by 19.7 points. The NASS and most of the SF 36 items improved significantly. In the multimodal treatment group, only the muscular function improved slightly. CONCLUSION: Our data support the hypothesis that WB-EMS is at least as effective as a multimodal treatment, which is often referred to as being the golden standard. Therefore WB-EMS may be an effective and, with 20 min./week training time, very time-efficient alternative to established multimodal treatment models.