Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss.

BACKGROUND: Lower limb amputation contributes to structural and functional brain alterations, adversely affecting gait, balance, and overall quality of life. Therefore, selecting an appropriate prosthetic ankle is critical in enhancing the well-being of these individuals. Despite the availability of various prostheses, their impact on brain neuroplasticity remains poorly understood. OBJECTIVES: The primary objective is to examine differences in the degree of brain neuroplasticity using magnetic resonance imaging (MRI) between individuals wearing a new passive ankle prosthesis with an articulated ankle joint and a standard passive prosthesis, and to examine changes in brain neuroplasticity within these two prosthetic groups. The second objective is to investigate the influence of prosthetic type on walking performance and quality of life. The final objective is to determine whether the type of prosthesis induces differences in the walking movement pattern. METHODS: Participants with a unilateral transtibial amputation will follow a 24-week protocol. Prior to rehabilitation, baseline MRI scans will be performed, followed by allocation to the intervention arms and commencement of rehabilitation. After 12 weeks, baseline functional performance tests and a quality of life questionnaire will be administered. At the end of the 24-week period, participants will undergo the same MRI scans, functional performance tests and questionnaire to evaluate any changes. A control group of able-bodied individuals will be included for comparative analysis. CONCLUSION: This study aims to unravel the differences in brain neuroplasticity and prosthesis type in patients with a unilateral transtibial amputation and provide insights into the therapeutic benefits of prosthetic devices. The findings could validate the therapeutic benefits of more advanced lower limb prostheses, potentially leading to a societal impact ultimately improving the quality of life for individuals with lower limb amputation. TRIAL REGISTRATION: NCT05818410 (Clinicaltrials.gov).

Test-retest, intra- and inter-rater reliability of the reactive balance test in patients with chronic ankle instability.

Introduction: The Reactive Balance Test (RBT) could be a valuable addition to research on chronic ankle instability (CAI) and clinical practice, but before it can be used in clinical practice it needs to be reliable. It has already been proven reliable in healthy recreational athletes, but not yet in patients with CAI who have shown persistent deficits in dynamic balance. The study aimed to determine the test-retest, intra-, and inter-rater reliability of the RBT in patients with CAI, and the test-retest and inter-rater reliability of the newly developed RBT score sheet. Methods: We used a repeated-measures, single-group design to administer the RBT to CAI patients on three occasions, scored by multiple raters. We included 27 participants with CAI. The study used multiple reliability measures, including Pearson r, intra-class correlations (ICC), standard error of measurement (SEM), standard error of prediction (SEP), minimal detectable change (MDC), and Bland-Altman plots, to evaluate the reliability of the RBT's outcome measures (visuomotor response time and accuracy). It also assessed the test-retest and inter-rater reliability of the RBT score sheet using the same measures. Results: The ICC measures for test-retest reliability were similar for accuracy (0.609) and VMRT (0.594). Intra-rater reliability had high correlations and ICCs for accuracy (r = 0.816, ICC = 0.815) and VMRT (r = 0.802, ICC = 0.800). Inter-rater reliability had a higher ICC for VMRT (0.868) than for accuracy (0.690). Conclusion: Test-retest reliability was moderate, intra-rater reliability was good, and inter-rater reliability showed moderate reliability for accuracy and good reliability for VMRT. Additionally, the RBT shows robust SEM and mean difference measures. The score sheet method also demonstrated moderate test-retest reliability, while inter-rater reliability was good to excellent. This suggests that the RBT can be a valuable tool in assessing and monitoring balance in patients with CAI.

Deficits in neurocognitive performance in patients with chronic ankle instability during a neurocognitive balance task - A retrospective case-control study.

OBJECTIVES: To assess the neurocognitive performance while maintaining balance of patients experiencing CAI compared to healthy controls. In patients with CAI, the affected limb was also compared to the contralateral limb. DESIGN: A retrospective case-control study. SETTING: Laboratory study. PARTICIPANTS: We included 27 patients with CAI and 21 healthy controls. METHODS: The study consisted of two sessions, namely familiarisation and experimentation, which were scheduled with a gap of at least one week between them. During the experimental trial, both groups performed the Y-Balance Test and Reactive Balance Test once on each limb. MAIN OUTCOME MEASURES: The main outcome measures are accuracy and visuomotor response time (VMRT) calculated via video-analysis and with the Fitlight™-hardware and software respectively during the Reactive Balance Test (RBT). RESULTS: No data was excluded from the final analysis. Patients with CAI exhibited significantly lower accuracy than healthy controls, with a mean difference of 8.7% (±3.0)%. There were no differences for VMRT between groups. Additionally, no significant differences were observed between the affected and contralateral limb of the patient group for both accuracy and VMRT. CONCLUSIONS: Patients with CAI showed lower accuracy, but similar VMRT compared to healthy controls during a neurocognitive balance task, indicating impaired neurocognitive function. Patients exhibit comparable speed to healthy individuals when completing neurocognitive balance tasks, yet they display a higher frequency of accuracy errors in accurately perceiving their environment and making decisions under time constraints. Future research should gain more insights in which other cognitive domains are affected in patients with CAI for a better grasp of this condition's underlying mechanism.

A cross-sectional case-control study on the structural connectome in recovered hospitalized COVID-19 patients.

COVID-19 can induce neurological sequelae, negatively affecting the quality of life. Unravelling this illness's impact on structural brain connectivity, white-matter microstructure (WMM), and cognitive performance may help elucidate its implications. This cross-sectional study aimed to investigate differences in these factors between former hospitalised COVID-19 patients (COV) and healthy controls. Group differences in structural brain connectivity were explored using Welch-two sample t-tests and two-sample Mann-Whitney U tests. Multivariate linear models were constructed (one per region) to examine fixel-based group differences. Differences in cognitive performance between groups were investigated using Wilcoxon Rank Sum tests. Possible effects of bundle-specific FD measures on cognitive performance were explored using a two-group path model. No differences in whole-brain structural organisation were found. Bundle-specific metrics showed reduced fiber density (p = 0.012, Hedges' g = 0.884) and fiber density cross-section (p = 0.007, Hedges' g = 0.945) in the motor segment of the corpus callosum in COV compared to healthy controls. Cognitive performance on the motor praxis and digit symbol substitution tests was worse in COV than healthy controls (p < 0.001, r = 0.688; p = 0.013, r = 422, respectively). Associations between the cognitive performance and bundle-specific FD measures differed significantly between groups. WMM and cognitive performance differences were observed between COV and healthy controls.

Brain Neuroplasticity Related to Lateral Ankle Ligamentous Injuries: A Systematic Review.

BACKGROUND: Lateral ankle sprains are the most common ankle injuries in sports and have the highest recurrence rates. Almost half of the patients experiencing lateral ankle sprains develop chronic ankle instability. Patients with chronic ankle instability experience persistent ankle dysfunctions and detrimental long-term sequelae. Changes at the brain level are put forward to explain these undesirable consequences and high recurrence rates partially. However, an overview of possible brain adaptations related to lateral ankle sprains and chronic ankle instability is currently lacking. OBJECTIVE: The primary purpose of this systematic review is to provide a comprehensive overview of the literature on structural and functional brain adaptations related to lateral ankle sprains and in patients with chronic ankle instability. METHODS: PubMed, Web of Science, Scopus, Embase, EBSCO-SPORTDiscus and Cochrane Central Register of Controlled Trials were systematically searched until 14 December, 2022. Meta-analyses, systematic reviews and narrative reviews were excluded. Included studies investigated functional or structural brain adaptations in patients who experienced a lateral ankle sprain or with chronic ankle instability and who were at least 18 years of age. Lateral ankle sprains and chronic ankle instability were defined following the recommendation of the International Ankle Consortium. Three authors independently extracted the data. They extracted the authors' name, publication year, study design, inclusion criteria, participant characteristics, the sample size of the intervention and control groups, methods of neuroplasticity testing, as well as all means and standard deviations of primary and secondary neuroplasticity outcomes from each study. Data reported on copers were considered as part of the control group. The quality assessment tool for observational and cross-sectional studies was used for the risk of bias assessment. This study is registered on PROSPERO, number CRD42021281956. RESULTS: Twenty articles were included, of which only one investigated individuals who experienced a lateral ankle sprain. In all studies combined, 356 patients with chronic ankle instability, 10 who experienced a lateral ankle sprain and 46 copers were included. White matter microstructure changes in the cerebellum have been related to lateral ankle sprains. Fifteen studies reported functional brain adaptations in patients with chronic ankle instability, and five articles found structural brain outcomes. Alterations in the sensorimotor network (precentral gyrus and supplementary motor area, postcentral gyrus and middle frontal gyrus) and dorsal anterior cingulate cortex were mainly found in patients with chronic ankle instability. DISCUSSION: The included studies demonstrated structural and functional brain adaptations related to lateral ankle sprains and chronic ankle instability compared to healthy individuals or copers. These adaptations correlate with clinical outcomes (e.g. patients' self-reported function and different clinical assessments) and might contribute to the persisting dysfunctions, increased re-injury risk and long-term sequelae seen in these patients. Thus, rehabilitation programmes should integrate sensorimotor and motor control strategies to cope with neuroplasticity related to ligamentous ankle injuries.

Continuous relative phases of walking with an articulated passive ankle-foot prosthesis in individuals with a unilateral transfemoral and transtibial amputation: an explorative case-control study.

BACKGROUND: A mechanical ankle-foot prosthesis (Talaris Demonstrator) was developed to improve prosthetic gait in people with a lower-limb amputation. This study aims to evaluate the Talaris Demonstrator (TD) during level walking by mapping coordination patterns based on the sagittal continuous relative phase (CRP). METHODS: Individuals with a unilateral transtibial amputation, transfemoral amputation and able-bodied individuals completed 6 minutes of treadmill walking in consecutive blocks of 2 minutes at self-selected (SS) speed, 75% SS speed and 125% SS speed. Lower extremity kinematics were captured and hip-knee and knee-ankle CRPs were calculated. Statistical non-parametric mapping was applied and statistical significance was set at 0.05. RESULTS: The hip-knee CRP at 75% SS walking speed with the TD was larger in the amputated limb of participants with a transfemoral amputation compared to able-bodied individuals at the beginning and end of the gait cycle (p = 0.009). In people with a transtibial amputation, the knee-ankle CRP at SS and 125% SS walking speeds with the TD were smaller in the amputated limb at the beginning of the gait cycle compared to able-bodied individuals (p = 0.014 and p = 0.014, respectively). Additionally, no significant differences were found between both prostheses. However, visual interpretation indicates a potential advantage of the TD over the individual's current prosthesis. CONCLUSION: This study provides lower-limb coordination patterns in people with a lower-limb amputation and reveals a possible beneficial effect of the TD over the individuals' current prosthesis. Future research should include a well-sampled investigation of the adaptation process combined with the prolonged effects of the TD.

Therapeutic benefits of lower limb prostheses: a systematic review.

BACKGROUND: Enhancing the quality of life of people with a lower limb amputation is critical in prosthetic development and rehabilitation. Yet, no overview is available concerning the impact of passive, quasi-passive and active ankle-foot prostheses on quality of life. OBJECTIVE: To systematically review the therapeutic benefits of performing daily activities with passive, quasi-passive and active ankle-foot prostheses in people with a lower limb amputation. METHODS: We searched the Pubmed, Web of Science, Scopus and Pedro databases, and backward citations until November 3, 2021. Only English-written randomised controlled trials, cross-sectional, cross-over and cohort studies were included when the population comprised individuals with a unilateral transfemoral or transtibial amputation, wearing passive, quasi-passive or active ankle-foot prostheses. The intervention and outcome measures had to include any aspect of quality of life assessed while performing daily activities. We synthesised the participants' characteristics, type of prosthesis, intervention, outcome and main results, and conducted risk of bias assessment using the Cochrane risk of bias tool. This study is registered on PROSPERO, number CRD42021290189. RESULTS: We identified 4281 records and included 34 studies in total. Results indicate that quasi-passive and active prostheses are favoured over passive prostheses based on biomechanical, physiological, performance and subjective measures in the short-term. All studies had a moderate or high risk of bias. CONCLUSION: Compared to passive ankle-foot prostheses, quasi-passive and active prostheses significantly enhance the quality of life. Future research should investigate the long-term therapeutic benefits of prosthetics devices.

Characterizing fall risk factors in Belgian older adults through machine learning: a data-driven approach.

BACKGROUND: Falls are a major problem associated with ageing. Yet, fall-risk classification models identifying older adults at risk are lacking. Current screening tools show limited predictive validity to differentiate between a low- and high-risk of falling. OBJECTIVE: This study aims at identifying risk factors associated with higher risk of falling by means of a quality-of-life questionnaire incorporating biological, behavioural, environmental and socio-economic factors. These insights can aid the development of a fall-risk classification algorithm identifying community-dwelling older adults at risk of falling. METHODS: The questionnaire was developed by the Belgian Ageing Studies research group of the Vrije Universiteit Brussel and administered to 82,580 older adults for a detailed analysis of risk factors linked to the fall incidence data. Based on previously known risk factors, 139 questions were selected from the questionnaire to include in this study. Included questions were encoded, missing values were dropped, and multicollinearity was assessed. A random forest classifier that learns to predict falls was trained to investigate the importance of each individual feature. RESULTS: Twenty-four questions were included in the classification-model. Based on the output of the model all factors were associated with the risk of falling of which two were biological risk factors, eight behavioural, 11 socioeconomic and three environmental risk factors. Each of these variables contributed between 4.5 and 6.5% to explaining the risk of falling. CONCLUSION: The present study identified 24 fall risk factors using machine learning techniques to identify older adults at high risk of falling. Maintaining a mental, physical and socially active lifestyle, reducing vulnerability and feeling satisfied with the living situation contributes to reducing the risk of falling. Further research is warranted to establish an easy-to-use screening tool to be applied in daily practice.

A data-driven machine learning approach for brain-computer interfaces targeting lower limb neuroprosthetics.

Prosthetic devices that replace a lost limb have become increasingly performant in recent years. Recent advances in both software and hardware allow for the decoding of electroencephalogram (EEG) signals to improve the control of active prostheses with brain-computer interfaces (BCI). Most BCI research is focused on the upper body. Although BCI research for the lower extremities has increased in recent years, there are still gaps in our knowledge of the neural patterns associated with lower limb movement. Therefore, the main objective of this study is to show the feasibility of decoding lower limb movements from EEG data recordings. The second aim is to investigate whether well-known neuroplastic adaptations in individuals with an amputation have an influence on decoding performance. To address this, we collected data from multiple individuals with lower limb amputation and a matched able-bodied control group. Using these data, we trained and evaluated common BCI methods that have already been proven effective for upper limb BCI. With an average test decoding accuracy of 84% for both groups, our results show that it is possible to discriminate different lower extremity movements using EEG data with good accuracy. There are no significant differences (p = 0.99) in the decoding performance of these movements between healthy subjects and subjects with lower extremity amputation. These results show the feasibility of using BCI for lower limb prosthesis control and indicate that decoding performance is not influenced by neuroplasticity-induced differences between the two groups.

Evaluation of an articulated passive ankle-foot prosthesis.

BACKGROUND: Current ankle prostheses for people with unilateral transtibial amputation (TTA) or transfemoral amputation (TFA) are unable to mimic able-bodied performance during daily activities. A new mechanical ankle-foot prosthesis was developed to further optimise the gait of people with a lower-limb amputation. This study aimed to evaluate the Talaris Demonstrator (TD) during daily activities by means of performance-related, physiological and subjective outcome measures. MATERIALS AND METHODS: Forty-two participants completed a protocol assessing performance and functional mobility with their current prosthesis and the TD. The protocol comprised the L-test, 2 min of stair climbing, 2 min of inclined treadmill walking, 6 min of treadmill walking at 3 different speeds in consecutive blocks of 2 min, and a 3-m Backward Walk test (3mBWT). Heart rate was measured during each task, and oxygen uptake was collected during all tasks except for the L-test and 3mBWT. Time of execution was recorded on the L-test and 3mBWT, and the rate of perceived exertion (score = 6-20), fatigue and comfort (score = 0-100) were assessed after each task. Paired sample t-tests and Wilcoxon Signed-rank tests were performed to compare outcomes between prosthetic devices. Benjamini-Hochberg corrections were applied to control for multiple comparisons with a level of significance set at α = 0.05. RESULTS: Subjects with a TTA (N = 28) were faster with their current prosthesis compared to the TD on the L-test and 3mBWT (p = 0.005). In participants with a TFA (N = 14), we observed a tendency towards a higher heart rate during the L-test and towards increased comfort during inclined walking, with the TD compared to the participants' current prosthetic device (0.05 < p < 0.10). Further, no significant results were observed. CONCLUSION: The Talaris Demonstrator is a novel state-of-the-art passive ankle-foot prosthesis for both people with a TTA and TFA. Subjective measures indicate the added value of this device, while overall task performance and intensity of effort do not differ between the Talaris Demonstrator and the current prosthesis. Further investigations unravelling both acute and more prolonged adaptations will be conducted to evaluate the TD more thoroughly.

Performance of the CYBERLEGs motorized lower limb prosthetic device during simulated daily activities.

Background: The CYBERLEGs-gamma (CLs-É£) prosthesis has been developed to investigate the possibilities of powerful active prosthetics in restoring human gait capabilities after lower limb amputation. Objective: The objective of this study was to determine the performance of the CLs-É£ prosthesis during simulated daily activities. Methods: Eight participants with a transfemoral amputation (age: 55 ± 15 years, K-level 3, registered under: NCT03376919) performed a familiarization session, an experimental session with their current prosthesis, three training sessions with the CLs-É£ prosthesis and another experimental session with the CLs-É£ prosthesis. Participants completed a stair-climbing-test, a timed-up-and-go-test, a sit-to stand-test, a 2-min dual-task and a 6-min treadmill walk test. Results: Comparisons between the two experimental sessions showed that stride length significantly increased during walking with the CLs-É£ prosthesis (p = .012) due to a greater step length of the amputated leg (p = .035). Although a training period with the prototype was included, preferred walking speed was significantly slower (p = .018), the metabolic cost of transport was significantly higher (p = .028) and reaction times significantly worsened (p = .012) when walking with the CLs-É£ compared to the current prosthesis. Conclusions: It can be stated that a higher physical and cognitive effort were required when wearing the CLs-É£ prosthesis. Positive outcomes were observed regarding stride length and stair ambulation. Future prosthetics development should minimize the weight of the device and integrate customized control systems. A recommendation for future research is to include several shorter training periods or a prolonged adaptation period.