Remote Short Sessions of Heart Rate Variability Biofeedback Monitored With Wearable Technology: Open-Label Prospective Feasibility Study.

BACKGROUND: Heart rate variability (HRV) biofeedback is often performed with structured education, laboratory-based assessments, and practice sessions. It has been shown to improve psychological and physiological function across populations. However, a means to remotely use and monitor this approach would allow for wider use of this technique. Advancements in wearable and digital technology present an opportunity for the widespread application of this approach. OBJECTIVE: The primary aim of the study was to determine the feasibility of fully remote, self-administered short sessions of HRV-directed biofeedback in a diverse population of health care workers (HCWs). The secondary aim was to determine whether a fully remote, HRV-directed biofeedback intervention significantly alters longitudinal HRV over the intervention period, as monitored by wearable devices. The tertiary aim was to estimate the impact of this intervention on metrics of psychological well-being. METHODS: To determine whether remotely implemented short sessions of HRV biofeedback can improve autonomic metrics and psychological well-being, we enrolled HCWs across 7 hospitals in New York City in the United States. They downloaded our study app, watched brief educational videos about HRV biofeedback, and used a well-studied HRV biofeedback program remotely through their smartphone. HRV biofeedback sessions were used for 5 minutes per day for 5 weeks. HCWs were then followed for 12 weeks after the intervention period. Psychological measures were obtained over the study period, and they wore an Apple Watch for at least 7 weeks to monitor the circadian features of HRV. RESULTS: In total, 127 HCWs were enrolled in the study. Overall, only 21 (16.5%) were at least 50% compliant with the HRV biofeedback intervention, representing a small portion of the total sample. This demonstrates that this study design does not feasibly result in adequate rates of compliance with the intervention. Numerical improvement in psychological metrics was observed over the 17-week study period, although it did not reach statistical significance (all P>.05). Using a mixed effect cosinor model, the mean midline-estimating statistic of rhythm (MESOR) of the circadian pattern of the SD of the interbeat interval of normal sinus beats (SDNN), an HRV metric, was observed to increase over the first 4 weeks of the biofeedback intervention in HCWs who were at least 50% compliant. CONCLUSIONS: In conclusion, we found that using brief remote HRV biofeedback sessions and monitoring its physiological effect using wearable devices, in the manner that the study was conducted, was not feasible. This is considering the low compliance rates with the study intervention. We found that remote short sessions of HRV biofeedback demonstrate potential promise in improving autonomic nervous function and warrant further study. Wearable devices can monitor the physiological effects of psychological interventions.

Prospective evaluation of the connected biofeedback EMY Kegel trainer in the management of stress urinary incontinence.

INTRODUCTION: The aim of this study was to evaluate changes in the quality of life with the connected biofeedback EMY Kegel trainer in patients suffering from stress urinary incontinence. Materiel and methods: This was a prospective, single-center, non-comparative study, which took place between September 2019 and October 2020, in the University Hospitals of Strasbourg. Eligible patients were instructed to use the EMY probe for a minimum of 10 min per day for five days per week. To assess quality of life and urinary symptoms, the Contilife and ICIQ-SF scores were completed each month until the final visit (M3). The PGI-I was also completed at 3 months to assess the benefit of the EMY Kegel Trainer. RESULTS: A total of 55 patients were included. At the inclusion visit (M0), the mean Contilife and ICIQ-SF scores were respectively at 6.6 ± 1.5 and 10.5 ± 3.0 points. At the final visit (M3), the mean Contilife score increased to 9.2 ± 1.0, indicating an improvement in quality of life. The mean ICIQ-SF score decreased to 4.2 ± 4.0, indicating an improvement in urinary symptoms. The PGI-I questionnaire identified a positive assessement of the EMY Kegel trainer. On the 55 patients included, 35 (64%) reported completing at least 36 sessions during the study, i.e. an average of 3 sessions per week. CONCLUSIONS: This study suggests that perineal rehabilitation by biofeedback using the EMY Kegel trainer might be beneficial.

Development of a modular stress management platform (Performance Edge VR) and a pilot efficacy trial of a bio-feedback enhanced training module for controlled breathing.

This paper describes the conceptual design of a virtual reality-based stress management training tool and evaluation of the initial prototype in a pilot efficacy study. Performance Edge virtual-reality (VR) was co-developed with the Australian Defence Force (ADF) to address the need for practical stress management training for ADF personnel. The VR application is biofeedback-enabled and contains key stress management techniques derived from acceptance and commitment and cognitive behavioural therapy in a modular framework. End-user-provided feedback on usability, design, and user experience was positive, and particularly complimentary of the respiratory biofeedback functionality. Training of controlled breathing delivered across 3 sessions increased participants' self-reported use of breath control in everyday life and progressively improved controlled breathing skills (objectively assessed as a reduction in breathing rate and variability). Thus the data show that a biofeedback-enabled controlled breathing protocol delivered through Performance Edge VR can produce both behaviour change and objective improvement in breathing metrics. These results confirm the validity of Performance Edge VR platform, and its Controlled Breathing module, as a novel approach to tailoring VR-based applications to train stress management skills in a workplace setting.

Biofeedback Training Improves Swallowing in a Unique Case of Upper Esophageal Sphincter Hypotonicity.

Hypotonicity of the upper esophageal sphincter (UES) has been reported only two times previously in the literature, with no reports of treatment options for this rarity. We present a third case of hypotonic UES found during high-resolution pharyngeal manometry. Although the patient had nearly absent resting pressures of the UES, pressures during and post-swallow were normal. It was hypothesized that the patient might be able to increase pre-swallow UES pressure using biofeedback. Using a chin up/out maneuver during manometry, the patient was able to achieve a more normal swallow pressure pattern. This case also highlights the need to complete manometry alongside other swallow imaging techniques for effective treatment planning and patient outcomes. Laryngoscope, 131:E1567-E1569, 2021.

A Qualitative Descriptive Study: Young Adults' Experiences With Biofeedback.

PURPOSE: This study explored the experiences of young adults who participated in biofeedback training and reported a family history of cardiovascular disease. DESIGN: A qualitative descriptive study design was used. METHOD: Private semistructured interviews were conducted on a purposive sample. Young adults (N = 9) were interviewed about their experiences using paced breathing biofeedback training with continuous blood pressure monitoring. Codes were identified across the sample with common themes recorded. FINDINGS: Data analysis yielded four themes: skeptical inquisition, tangible impression, positive health impact, and motivation. Prior to using biofeedback, participants were extremely skeptical of the training. However, all participants found it useful for health maintenance and stress reduction. CONCLUSIONS: Biofeedback therapy may be a promising alternative and holistic approach to managing blood pressure and psychological stress in young adults. This is a complementary approach that nurses can incorporate when caring for the holistic needs of young adults.

Is Biofeedback through an Intra-Aural Device an Effective Method to Treat Bruxism? Case Series and Initial Experience.

Biofeedback was reported as an effective concept for bruxism treatment, through increasing patient's awareness of the habit. During bruxing both ear canals become tighter, therefore, an in-ear device can provide biofeedback. The in-ear device is fitted to the ear canal in physiological status, during bruxing the ear-canal tightens resulting in stress on the canal walls and unpleasant feeling. Subsequently, patients stop their bruxing habit. The aim of this study is to provide first clinical evidence that in-ear devices have a positive impact on relieving bruxism in patients. Despite the low number of patients, this early study was designed as a controlled prospective study. The trial included seven female patients with a median age of 47.3 years (23-64 years). Only two patients implemented their devices for eight and seven months, respectively. One patient reported a relief in her symptoms, like headaches and pain intensity during the night, by 50% after three month and 80% after six months. Despite the limited number of participants, the study reflects a potential of Intra-aural devices as effective biofeedback devices in treating bruxism.

Impact of smart force feedback rehabilitation robot training on upper limb motor function in the subacute stage of stroke.

OBJECTIVE: To explore the impact of rehabilitation robot training (RRT) on upper limb motor function and daily activity ability in patients with stroke. METHODS: Forty patients meeting the inclusion criteria were randomly divided into the treatment group (TRE) and the control group (CON). Group TRE was trained with an upper limb rehabilitation robot and group CON was trained with traditional occupational therapy. The training time was six weeks, and the upper limb function and daily activities were then assessed. RESULTS: (1) There was no statistical significance in the Fugl-Meyer (FM) score, Wolf Motor Function Test (WMFT) score, and Modified Barthel Index (MBI) score between the two groups before treatment (P > 0.05). (2) After treatment, the FM score, WMFT score, and MBI score were significantly higher than before treatment (P < 0.01). (3) There was no significant significance between the two groups after treatment (P > 0.05). CONCLUSIONS: Both RRT and traditional occupational therapy training are useful for the recovery of upper limb motor function and daily life ability in the sub-acute stage of stroke.

Feasibility of the Archercise biofeedback device to strengthen foot musculature.

BACKGROUND: Foot muscle weakness can produce foot deformity, pain and disability. Toe flexor and foot arch exercises focused on intrinsic foot muscle strength and functional control may mitigate the progression of foot deformity and disability. Ensuring correct exercise technique is challenging due to the specificity of muscle activation required to complete some foot exercises. Biofeedback has been used to improve adherence, muscle activity and movement patterns. We investigated the feasibility of using a novel medical device, known as "Archercise", to provide real-time biofeedback of correct arch movement via pressure change in an inflatable bladder, and foot location adherence via sensors embedded in a footplate during four-foot exercises. METHODS: Thirty adults (63% female, aged 23-68 years) performed four-foot exercises twice on the Archercise sensor footplate alone and then with biofeedback. One-way repeated measures ANOVA with pairwise comparisons were computed to assess the consistency of the exercise protocol between trial 1 and trial 2 (prior to biofeedback), and the effectiveness of the Archercise biofeedback device between trial 2 and trial 3 (with biofeedback). Outcome measures were: Arch movement exercises of arch elevation and lowering speed, controlled arch elevation, controlled arch lowering, endurance of arch elevation; Foot location adherence was determined by percentage of time the great toe, fifth toe and heel contacted footplate sensors during testing and were analysed with paired sample t-tests. Participant survey comments on the use of Archercise with biofeedback were reported thematically. RESULTS: Seventeen (89%) arch movement and foot location variables were collected consistently with Archercise during the foot exercises. Archercise with biofeedback improved foot location adherence for all exercises (p = 0.003-0.008), coefficient of determination for controlled arch elevation (p < 0.0001) and endurance area ratio (p = 0.001). Twenty-nine (97%) participants reported Archercise with biofeedback, helped correct exercise performance. CONCLUSIONS: Archercise is a feasible biofeedback device to assist healthy participants without foot pathologies perform foot doming exercises. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): 12616001559404. Registered 11 November 2016, http://www.ANZCTR.org.au/ACTRN12616001559404p.aspx.

Reducing lumbar spine flexion using real-time biofeedback during patient handling tasks.

BACKGROUND: Patient handling activities require caregivers to adopt postures that increase the risk of back injury. Training programs relying primarily on didactic methods have been shown to be ineffective at reducing this risk. The use of real-time biofeedback has potential as an alternative training method. OBJECTIVE: To investigate the effect of real-time biofeedback on time spent by caregivers in end-range lumbar spine flexion. METHODS: Novice participants were divided into intervention (n = 10) and control (n = 10) groups and were asked to perform a set of simulated care activities eight times on two consecutive days. Individuals in the intervention group watched a training video on safer movement strategies and received real-time auditory feedback from a wearable device (PostureCoach) in four training trials whenever their lumbar spine flexion exceeded a threshold (70% of maximum flexion). Changes in end-range lumbar spine flexion were compared between groups and across trials. RESULTS: Participants in the intervention group saw reductions in end-range lumbar spine flexion during the simulated patient handling tasks at the end of the training compared to their baseline trials while there was no change for the control group. CONCLUSIONS: The training program including PostureCoach has the potential to help caregivers learn to use safer postures that reduce the risk of back injury.

Evaluating the Impact of Freespira on Panic Disorder Patients' Health Outcomes and Healthcare Costs within the Allegheny Health Network.

Panic disorder (PD) is a debilitating condition that drives medical spending at least twice as high as medically matched controls. Excessive utilization of healthcare resources comes from emergency department (ED), medications, diagnostic testing, and physician visits. Freespira is an FDA-cleared digital therapeutic that treats PD and panic attacks (PA) by correcting underlying abnormal respiratory physiology. Efficacy of Freespira has been established in prior studies. This paper reports on a quality improvement program that investigated whether treating PD patients with Freespira would reduce medical costs and improve outcomes over 12-months. Panic symptoms were assessed using the Panic Disorder Severity Scale (PDSS). Pre-and post-treatment insurance claims determined costs. At baseline, mean Clinician Global Impression (CGI-S) was 4.4 (moderately/markedly ill), mean PDSS was 14.4 and mean PA frequency/week was 2 (range 0-5). Immediately post-treatment (week 5) mean CGI-S, PDSS and weekly PA frequency declined to 2.8 (borderline/mildly ill, 4.9 (remission) and 0.2 (range 0-2) respectively, p < 0.001. 82% reported PDSS decrease of ≥ 40% (clinically significant), 86% were PA-free. One-year post treatment mean CGI-S, PDSS and PA remained low at 2.1, 4.4, and 0.3 (range 0-1) respectively. 91% had PDSS decrease of ≥ 40%, 73% were PA-free. The majority of patients were panic attack free and/or reduced their symptoms and avoidance behaviors 1-year post Freespira treatment. Mean overall medical costs were reduced by 35% from $548 to $358 PMPM (per member per month) or an annual reduction of $2280. at 12 months post-treatment. There was a 65% reduction in ED costs from $87 to $30 PMPM. Median pharmacy costs were reduced by 68% from $73 to $23 PMPM.

Effect of Posture Feedback Training on Health.

Collapsed or slouching posture has been associated with negative health outcomes such as pain, depression, and overall stress ratings as well as declines in general health, emotional well-being, and energy/fatigue levels. Currently, wearable devices and accompanying smartphone applications (apps) can provide feedback about shifting posture (e.g., erect vs. collapsed or slouching positions), as well as provide suggestions that support positive posture awareness. This study investigates the effect of a wearable 'UpRight' posture-feedback device on self-reports of pain, mood, and performance in comparison to a non-treatment control group. 56 Student participants filled out the SF-36 RAND Health Survey at the beginning and end of the 4-week study. The treatment group (n = 13) used a wearable device for at least 15 min per day, for 4 weeks, while a matched comparison group (n = 13) participated without the device over the same period. Evaluations before and after the 4 weeks included the SF-36, as well as qualitative descriptions of their experiences. The treatment group significantly improved on the SF-36 measures of physical functioning, emotions, energy/fatigue, confidence and overall stress ratings, as well as on subjective ratings of neck and back posture as compared to the control group. The wearable biofeedback device positively influenced awareness of neck and back posture, as well as key measures on the RAND SF-36 Health Survey. This study provides preliminary support that a wearable posture feedback device is a useful tool to teach posture awareness and improve well-being.

Feasibility and Efficacy of the Addition of Heart Rate Variability Biofeedback to a Remote Digital Health Intervention for Depression.

A rise in the prevalence of depression underscores the need for accessible and effective interventions. The objectives of this study were to determine if the addition of a treatment component showing promise in treating depression, heart rate variability-biofeedback (HRV-B), to our original smartphone-based, 8-week digital intervention was feasible and whether patients in the HRV-B ("enhanced") intervention were more likely to experience clinically significant improvements in depressive symptoms than patients in our original ("standard") intervention. We used a quasi-experimental, non-equivalent (matched) groups design to compare changes in symptoms of depression in the enhanced group (n = 48) to historical outcome data from the standard group (n = 48). Patients in the enhanced group completed a total average of 3.86 h of HRV-B practice across 25.8 sessions, and were more likely to report a clinically significant improvement in depressive symptom score post-intervention than participants in the standard group, even after adjusting for differences in demographics and engagement between groups (adjusted OR 3.44, 95% CI [1.28-9.26], P = .015). Our findings suggest that adding HRV-B to an app-based, smartphone-delivered, remote intervention for depression is feasible and may enhance treatment outcomes.

Biofeedback Treatment App for Pediatric Migraine: Development and Usability Study.

OBJECTIVE: The objective of this study was to develop and investigate the usability of a biofeedback treatment smartphone app for adolescent migraine sufferers. BACKGROUND: Biofeedback is effective in treating pediatric migraine. However, biofeedback is not widely used due to the necessity of a trained therapist and specialized equipment. Emerging digital technology, including smartphones and wearables, enables new ways of administering biofeedback. METHODS: In a prospective open-label development and usability study, 10 adolescent migraine sufferers used a newly developed biofeedback app with wearable sensors that measured their muscle tension, finger temperature, and heart rate. Three iterative rounds of usability testing, including a 2-week home testing period, were completed. A biofeedback algorithm, combining and optimizing the 3 physiological modalities, and several algorithms for sham-treatment were created. Usability was evaluated statistically and summarized thematically. RESULTS: Five of ten participants completed all 3 rounds of usability testing. A total of 72 biofeedback sessions were completed. Usability scoring was consistently high, with median scores ranging from 3.5 to 4.5 on a 5-point scale. The biofeedback optimization algorithm correlated excellently to the raw physiological measurements (r = 0.85, P < .001). The intervention was safe and tolerable. CONCLUSION: We developed an app for young migraine sufferers to receive therapist-independent biofeedback. The app underwent a rigorous development process as well as usability and feasibility testing. It is now ready for clinical trials.

Heart Rate Variability Biofeedback to Treat Fibromyalgia: An Integrative Literature Review.

OBJECTIVES: Fibromyalgia (FM) is associated with debilitating pain and a reduced heart rate variability (HRV), reflecting decreased emotional adaptability and resistance to stress. Common pharmacological treatments are ineffective, and opioids are highly addictive and cause an estimated 15,000 overdose deaths per year. Effective recommendations include patient-centered interventions like physical activity, cognitive behavioral therapy, and biofeedback. Heart rate variability biofeedback (HRVB) may be effective in improving HRV, thus increasing stress resistance and emotional adaptability and reducing pain. DESIGN: This integrative literature review was conducted to examine the relationship between HRVB and FM-related chronic pain using the Theory of Symptom Self-Management and to identify available HRVB technology. DATA SOURCES: We searched PubMed, EBSCOhost, and Google Scholar electronic databases for relevant publications. Manuscripts were selected using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses strategy, and study quality was assessed using the Critical Appraisal Skills Programme guidelines. The relationship between HRVB and FM was analyzed and evaluated based on the methodological framework proposed by Whittemore and Knafl. REVIEW/ANALYSIS METHODS: We reviewed 22 articles and included six in this review. Five reported HRVB as a treatment for chronic pain, and one for FM pain. RESULTS: Overall, the articles in this review support the claim that HRVB is related to decreased pain. The researchers evaluated five HRVB programs, three on handheld devices and two on desktop computers. CONCLUSIONS: The reviewed studies had methodological flaws. However, HRVB is a promising treatment for chronic pain. Larger, randomized controlled studies are needed to thoroughly evaluate the relationship between HRVB and FM pain.

Correlation of force sense error test measured by a pressure biofeedback unit and EMG activity of quadriceps femoris in healthy individuals.

BACKGROUND: Our study developed a force sense error test (FSET) method for use on the quadriceps muscle, which could be employed in clinical practice to correlate the results of quadriceps muscle activity levels determined by surface electromyography (sEMG). METHODS: Twenty-four healthy individuals were included in the study. A pressure biofeedback unit (PBU) placed under the knee joint, was used for force sense error test (FSET) evaluation. First, a maximum contraction value was determined with the PBU. Next, 50% and 65% of the maximum contraction value were used for the analysis. Concurrently, norm values for the quadriceps muscle activity levels were determined by sEMG. Simultaneously, quadriceps muscle activity levels were recorded while testing the FSET using the PBU. Each measurement was repeated in triplicate, and the average constant errors observed by the PBU were recorded in mmHg. RESULTS: The FSET for both 50% and 65% of the normal mmHg value determined using the PBU positively correlated with activity change levels in the quadriceps muscle determined by sEMG (p < 0.05). CONCLUSIONS: The relationship between the FSET measured using PBU and changes in the level of activity in the quadriceps muscle showed that a PBU can be used in clinical practice for proprioceptive evaluation of the knee region.

A Biofeedback App to Instruct Abdominal Breathing (Breathing-Mentor): Pilot Experiment.

BACKGROUND: Deep and slow abdominal breathing is an important skill for the management of stress and pain. However, despite multiple proofs on the effectiveness of biofeedback, most breathing apps remain limited to pacing specific breathing patterns, without sensor feedback on the actual breathing behavior. OBJECTIVE: To fill this gap, an app named Breathing-Mentor was developed. This app combines effective visualization of the instruction with biofeedback on deep abdominal breathing, based on the mobile phone's accelerometers. The aim of this pilot study was to investigate users' feedback and breathing behavior during initial contact with the app. METHODS: To reveal the possible effects of biofeedback, two versions of the mobile app were developed. Both contained the same visual instruction, but only the full version included additional biofeedback. In total, 40 untrained participants were randomly assigned to one of the two versions of the app. They had to follow the app's instructions as closely as possible for 5 min. RESULTS: The group with additional biofeedback showed an increased signal-to-noise ratio for instructed breathing frequency (0.1 Hz) compared with those using visual instruction without biofeedback (F1,37=4.18; P<.048). During this initial contact with the full version, self-reported relaxation effectivity was, however, lower than the group using visual instruction without biofeedback (t37=-2.36; P=.02), probably owing to increased cognitive workload to follow the instruction. CONCLUSIONS: This study supports the feasibility and usefulness of incorporating biofeedback in the Breathing-Mentor app to train abdominal breathing. Immediate effects on relaxation levels should, however, not be expected for untrained users.

RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.

INTRODUCTION: Low back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP. METHODS AND ANALYSIS: Pragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L . ETHICS AND DISSEMINATION: Approved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).

Influences of the biofeedback content on robotic post-stroke gait rehabilitation: electromyographic vs joint torque biofeedback.

BACKGROUND: Add-on robot-mediated therapy has proven to be more effective than conventional therapy alone in post-stroke gait rehabilitation. Such robot-mediated interventions routinely use also visual biofeedback tools. A better understanding of biofeedback content effects when used for robotic locomotor training may improve the rehabilitation process and outcomes. METHODS: This randomized cross-over pilot trial aimed to address the possible impact of different biofeedback contents on patients' performance and experience during Lokomat training, by comparing a novel biofeedback based on online biological electromyographic information (EMGb) versus the commercial joint torque biofeedback (Rb) in sub-acute non ambulatory patients. 12 patients were randomized into two treatment groups, A and B, based on two different biofeedback training. For both groups, study protocol consisted of 12 Lokomat sessions, 6 for each biofeedback condition, 40 min each, 3 sessions per week of frequency. All patients performed Lokomat trainings as an add-on therapy to the conventional one that was the same for both groups and consisted of 40 min per day, 5 days per week. The primary outcome was the Modified Ashworth Spasticity Scale, and secondary outcomes included clinical, neurological, mechanical, and personal experience variables collected before and after each biofeedback training. RESULTS: Lokomat training significantly improved gait/daily living activity independence and trunk control, nevertheless, different effects due to biofeedback content were remarked. EMGb was more effective to reduce spasticity and improve muscle force at the ankle, knee and hip joints. Robot data suggest that Rb induces more adaptation to robotic movements than EMGb. Furthermore, Rb was perceived less demanding than EMGb, even though patient motivation was higher for EMGb. Robot was perceived to be effective, easy to use, reliable and safe: acceptability was rated as very high by all patients. CONCLUSIONS: Specific effects can be related to biofeedback content: when muscular-based information is used, a more direct effect on lower limb spasticity and muscle activity is evidenced. In a similar manner, when biofeedback treatment is based on joint torque data, a higher patient compliance effect in terms of force exerted is achieved. Subjects who underwent EMGb seemed to be more motivated than those treated with Rb.

Development and Validation of Ambulosono: A Wearable Sensor for Bio-Feedback Rehabilitation Training.

Wearable technology-based measurement systems hold potential for the therapeutic and rehabilitation management of patients with various chronic diseases. The purpose of this study was to assess the accuracy and test⁻retest reliability of a new-generation wearable sensor-based system, dubbed Ambulosono, for bio-feedback training. The Ambulosono sensor system was cross-validated by comparing its functionality with the iPod touch (4th generation) sensor system. Fifteen participants underwent a gait test to measure various gait parameters while wearing both the iPod-based and Ambulosono sensors simultaneously. The physically measured values (i.e., the true values) of step length, distance traveled, velocity, and cadence were then compared to those obtained via the two-sensor systems using the same calculation algorithms. While the mean percentage error was <10% for all measured parameters, and the intra-class correlation coefficient revealed a high level of agreement between trials for both sensor systems, it was found that the Ambulosono sensor system outperformed the iPod-based system in some respects. The Ambulosono sensor system possessed both reliability and accuracy in obtaining gait parameter measurements, which suggests it can serve as an economical alternative to the iPod-based system that is currently used in various clinical rehabilitation programs.

The role of wearables in spinal posture analysis: a systematic review.

BACKGROUND: Wearables consist of numerous technologies that are worn on the body and measure parameters such as step count, distance travelled, heart rate and sleep quantity. Recently, various wearable systems have been designed capable of detecting spinal posture and providing live biofeedback when poor posture is sustained. It is hypothesised that long-term use of these wearables may improve spinal posture. RESEARCH QUESTIONS: To (1) examine the capabilities of current devices assessing spine posture, (2) to identify studies implementing such devices in the clinical setting and (3) comment on the clinical practicality of integration of such devices into routine care where appropriate. METHODS: A comprehensive systematic review was conducted in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Guidelines (PRISMA) across the following databases: PubMed; MEDLINE; EMBASE; Cochrane; and Scopus. Articles related to wearables systems able to measure spinal posture were selected amongst all published studies dated from 1980 onwards. Extracted data was collected as per a predetermined checklist including device types, study objectives, findings and limitations. RESULTS: A total of 37 articles were extensively reviewed and analysed in the final review. The proposed wearables most commonly used Inertial Measurement Units (IMUs) as the underlying technology. Wearables measuring spinal posture have been proposed to be used in the following settings: post-operative rehabilitation; treatment of musculoskeletal disorders; diagnosis of pathological spinal posture; monitoring of progression of Parkinson's Disease; detection of falls; workplace occupational health and safety; comparison of interventions. CONCLUSIONS: This is the first and only study to specifically review wearable devices that monitor spinal posture. Our findings suggest that currently available devices are capable of assessing spinal posture with good accuracy in the clinical setting. However, further validation regarding the long-term use of these technologies and improvements regarding practicality is required for commercialisation.