Phantom motor execution as a treatment for phantom limb pain:protocol of an international, double-blind, randomised controlled clinical trial

Introduction Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP. Methods and analysis Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient's own impression. Follow-up interviews are conducted up to 6 months after the treatment. Ethics and dissemination The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal

Long-term risk prediction after major lower limb amputation: 1-year results of the PERCEIVE study

Background: Decision-making when considering major lower limb amputation is complex and requires individualized outcome estimation. It is unknown how accurate healthcare professionals or relevant outcome prediction tools are at predicting outcomes at 1-year after major lower limb amputation. Methods: An international, multicentre prospective observational study evaluating healthcare professional accuracy in predicting outcomes 1 year after major lower limb amputation and evaluation of relevant outcome prediction tools identified in a systematic search of the literature was undertaken. Observed outcomes at 1 year were compared with: healthcare professionals' preoperative predictions of death (surgeons and anaesthetists), major lower limb amputation revision (surgeons) and ambulation (surgeons, specialist physiotherapists and vascular nurse practitioners); and probabilities calculated from relevant outcome prediction tools. Results: A total of 537 patients and 2244 healthcare professional predictions of outcomes were included. Surgeons and anaesthetists had acceptable discrimination (C-statistic = 0.715), calibration and overall performance (Brier score = 0.200) when predicting 1-year death, but performed worse when predicting major lower limb amputation revision and ambulation (C-statistics = 0.627 and 0.662 respectively). Healthcare professionals overestimated the death and major lower limb amputation revision risks. Consultants outperformed trainees, especially when predicting ambulation. Allied healthcare professionals marginally outperformed surgeons in predicting ambulation. Two outcome prediction tools (C-statistics = 0.755 and 0.717, Brier scores = 0.158 and 0.178) outperformed healthcare professionals' discrimination, calibration and overall performance in predicting death. Two outcome prediction tools for ambulation (C-statistics = 0.688 and 0.667) marginally outperformed healthcare professionals. Conclusion: There is uncertainty in predicting 1-year outcomes following major lower limb amputation. Different professional groups performed comparably in this study. Two outcome prediction tools for death and two for ambulation outperformed healthcare professionals and may support shared decision-making

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Ultrasonographic presentation of nodular cystic fat necrosis after a low-velocity trauma : a case report

Objective: Morel-Lavallée lesion is a well-known entity after a high-energy, shearing trauma. Another form of lesion in the subcutaneous tissue is fat necrosis, presenting as a palpable mass. The most common presentation of fat necrosis is oil cysts, which occur mainly in the breast. However, in the lower extremities fat necrosis appears as nodular cystic fat necrosis. We report here a case of a patient with multiple injuries after a low-velocity trauma, who developed fat necrosis.Results: Six months after the traumatic event the patient reported multiple subcutaneous lumps on the right knee. On ultrasonography, the probable diagnosis of post-traumatic fat necrosis with consequent development of nodular cystic fat necrosis was seen. The diagnosis was confirmed based on magnetic resonance imaging (MRI).Discussion: Fat necrosis should be included in the differential diagnosis in cases of tissue injuries after a trauma. Fat necrosis can present months or years after the initial injury. It is a benign entity and is the result of an organized haemorrhage, swelling and oedema that progresses with fibrosis. There is no absolute need for surgical treatment. LAY ABSTRACTNodular cystic fat necrosis presents as palpable lumps, most commonly on the lower extremities after a trauma. Patients may report these cystic structures many months after the trauma. This case report illustrates the ultrasonographic appearance of nodular cystic fat necrosis. This is a benign finding that does not require treatment or removal if no pain or aesthetic discomfort is present

User accommodation to an active microprocessor-controlled knee in individuals with unilateral transfemoral amputation: a 5-week non-randomized trial

Abstract Background Evaluation studies on active microprocessor-controlled knees (AMPK) in individuals with unilateral transfemoral amputation (TFA) are lacking in the literature. Furthermore, research on user accommodation to AMPK remains to be investigated. Hence, this study aims to conduct a comparison between an AMPK and individual’s current prosthesis and assess the accommodation to using an AMPK during daily activities over a 5-week period on functional performance tests. Methods Participants with TFA completed a protocol comprising L-test, slope walking, level walking (2MWT) and dual-task level walking (dual-2MWT) once a week with their current prosthesis and the AMPK. The outcomes of interest were the distance covered during the 2MWT and dual-2MWT, time required to perform the L-test, accuracy of the serial subtractions during the dual-2MWT, heart rate (HR), rating of perceived exertion, fatigue, comfort and perceived workload. Generalised least-squared models were built to investigate differences in prosthetic conditions over time. Pearson correlations were calculated to determine associations between the performance and subjective outcomes. The level of significance was set at 0.05. Results Seven participants (age = 53 years ± 14 years) completed the study. Over time, the AMPK participants took longer to complete the L-test than their current prosthesis (p < 0.001). They reported higher fatigue (p = 0.033), lower comfort (p = 0.010), and higher perceived exertion with the AMPK (p = 0.048). Slope walking showed no significant walking speed or HR differences except higher HR with the AMPK in session 3 (p = 0.032). Dual-task level walking demonstrated lower walking speed with the AMPK (p = 0.035) and more responses to serial subtractions in sessions two (p = 0.043) and four (p = 0.023). No other differences between conditions were found on one of the functional tests. Weak associations (|r|= 0–0.5) were observed between performance and subjective measures. Conclusion Using the AMPK highlights initial challenges in task completion times and subjective comfort and fatigue levels. Our findings indicate that five one-hour sessions are insufficient for achieving user accommodation, and underscore the need for further research with a larger sample, continued prosthetic use and user accommodation to enhance prosthetic functioning and user experiences. Trial registration: NCT05407545

Cross-cultural adaptation and psychometric evaluation of the Dutch version of the Work Rehabilitation Questionnaire (WORQ-VL)

Purpose: The Work Rehabilitation Questionnaire (WORQ) was developed to evaluate work functioning in vocational rehabilitation, but was not yet available in Dutch. The goal of this study is twofold: a description of the cross-cultural adaptation process (part 1) of the WORQ to be used in Flanders (The Dutch speaking part of Belgium, WORQ-VL) and a presentation of the first psychometric testing of the WORQ-VL (part 2). Methods: For part 1, the guidelines for cross-cultural adaptation of self-report measures by Beaton et al. were used to structure the cross-cultural adaptation. For part 2, a cross-sectional study was conducted in patients with musculoskeletal disorders [sample A: hand and wrist rehabilitation (n = 21) and sample B: fibromyalgia patients (n = 93)] who completed the WORQ-VL. Internal consistency and factor structure were examined in the total sample, whereas convergent and discriminant validity of the WORQ-VL were researched in sample A. Results: First results on the convergent validity and discriminant validity (small sample size) and internal consistency of the WORQ-VL are promising. The exploratory factor analysis revealed seven factors which were labeled as 'cognition', 'physical', 'mood', 'activities of daily living', 'sensory', 'emotional' and 'social'. The best evidence was found for the 'physical' subscale of the WORQ-VL: strong correlations were found with the 'physical functioning' and 'role limitations-physical' subscales of the Short-Form Health Survey, respectively r = -.84 and r = -.59, p .05). Conclusions: The WORQ-VL is a user-friendly and valuable ICF-based self-report questionnaire to evaluate work functioning. Future studies are highly needed to examine the value of the WORQ within different patient populations and settings in order to examine further the added value of this self-report measure