Functional performance of a vibrotactile sensory substitution device in people with profound vision loss.

SIGNIFICANCE: This study has shown a vibrotactile sensory substitution device (SSD) prototype, VibroSight, has the potential to improve functional outcomes (i.e., obstacle avoidance, face detection) for people with profound vision loss, even with brief familiarization (<20 minutes). PURPOSE: Mobility aids such as long canes are still the mainstay of support for most people with vision loss, but they do have limitations. Emerging technologies such as SSDs are gaining widespread interest in the low vision community. The aim of this project was to assess the efficacy of a prototype vibrotactile SSD for people with profound vision loss in the face detection and obstacle avoidance tasks. METHODS: The VibroSight device was tested in a movement laboratory setting. The first task involved obstacle avoidance, in which participants were asked to walk through an obstacle course. The second was a face detection task, in which participants were asked to step toward the first face they detected. Exit interviews were also conducted to gather user experience data. Both people with low vision (n = 7) and orientation and mobility instructors (n = 4) completed the tasks. RESULTS: In obstacle avoidance task, participants were able to use the device to detect (p<0.001) and avoid (p<0.001) the obstacles within a significantly larger range, but were slower (p<0.001), when compared with without the device. In face detection task, participants demonstrated a great level of accuracy, precision, and sensitivity when using the device. Interviews revealed a positive user experience, although participants identified that they would require a lighter and compact design for real-world use. CONCLUSIONS: Overall, the results verified the functionality of vibrotactile SSD prototype. Further research is warranted to evaluate the user performance after an extended training program and to add new features, such as object recognition software algorithms, into the device.

Challenges and opportunities in testing sensorimotor processing with tendon vibration and transcranial magnetic stimulation in subacromial impingement syndrome: A case series.

BACKGROUND: Non-invasive neurostimulation like muscle tendon vibration (VIB) and transcranial magnetic stimulation (TMS) can provide valuable insights on mechanisms underlying sensorimotor dysfunctions. However, their feasibility in the context of painful musculoskeletal disorders like shoulder impingement syndrome (SIS) remain uncertain. METHODS: The present work used a case series design including 15 participants with SIS, as well as a secondary group-based analysis comparing participants with SIS to 15 healthy counterparts. Proprioceptive processing was tested by VIB-induced kinesthetic illusions of shoulder abduction, and TMS tested corticospinal excitability of the upper trapezius. Detailed individual data were collected, including any technical challenges and feasibility issues encountered. RESULTS: VIB was in general well-tolerated and elicited a perceptible kinesthetic illusion in 13 participants with SIS and 14 controls. TMS presented with several challenges related to discomfort, fear-related behaviors, technical problems and high motor thresholds, especially in participants with SIS. It was only possible to collect all TMS measures in 5 participants with SIS (for both the painful and non/less-painful sides), in 7 controls on their dominant side and 10 controls on the non-dominant side. The only significant group-based analysis was a lower illusion speed/amplitude on the painful versus non-painful side in persons with SIS (p = 0.035). CONCLUSION: Our study provides preliminary data on challenges encountered with TMS and VIB of trunk/proximal muscle in persons with SIS and healthy counterparts. It might help future studies to better address those challenges beforehand and improve the overall feasibility and impact of neurostimulation tools in musculoskeletal disorders.

Effects of whole-body vibration on body composition, microbiota, cardiometabolic markers, physical fitness, and quality of life after bariatric surgery: protocol for a randomized controlled trial.

BACKGROUND: Morbid obesity is a complex chronic condition characterized by a body mass index of 40 kg/m2 or higher. The incidence of the condition is on the rise in developed countries, and bariatric surgery has been proposed as a potential solution to address this trend. Nonetheless, bariatric surgery may also result in adverse effects, including a reduction in bone mineral density (BMD) and muscle mass, as well as an increased risk of fractures. The present study aims to elucidate the effects of bariatric surgery and whole-body vibration (WBV) training on body composition, microbiota, physical fitness, quality of life, and cardiometabolic markers. METHODS: Twenty-eight participants (14 females), aged 18 to 50 years, will undergo sleeve gastrectomy surgery. They will be randomly allocated into a control group or a WBV training group. The WBV group will train three times per week with increasing intensities and duration ranging from 30 to 45 min over the 4-month training period. Measurements of body composition (dual-energy X-ray absorptiometry and peripheral quantitative computed tomography), physical fitness (muscular strength, agility, cardiorespiratory fitness, and balance), gait biomechanics, cardiometabolic markers, gut microbiota, quality of life, and physical activity levels will be collected at four different time points: (1) prior to the surgery, (2) 45 days post-surgery, (3) 6 months post-surgery, and (4) 18 months post-surgery. DISCUSSION: Both groups are expected to experience improvements in most of the aforementioned variables. Nonetheless, we expect the WBV group to show larger improvements proving that the training is effective and safe. TRIAL REGISTRATION: Clinicaltrials.gov NCT05695599. Registered on January 25, 2023.

Clinical Impact of Thermotherapy and Spinal Twisting Massage on Chronic Non-Specific Spinal Pain.

As the prevalence of chronic non-specific spinal pain rises, the utilization of diverse massage devices for therapeutic intervention increases rapidly. However, research on their mechanisms, particularly those involving spinal twisting, is limited. This study was designed to evaluate the impact of heat application and spinal twisting massage techniques on individuals suffering from chronic non-specific spinal pain. A total of 36 individuals were divided into two groups: a control group (18 participants) and an experimental group (18 participants). The experimental group received heat treatment plus spinal twisting massage twice a week for four weeks, while the control group received heat therapy plus traditional vibration massage techniques. Effectiveness was measured using the Visual Analog Scale (VAS), the Pressure Pain Threshold (PPT), the Korean Western Ontario and McMaster Universities (K-WOMAC) Index, spine tilt, and Cobb angle. VAS, K-WOMAC, and PPT significantly improved in both groups at all three time points. VAS notably decreased in the experimental group compared to the control group (p-value: 0.0369). Despite improvements in K-WOMAC and PPT scores within the experimental group, statistical significance remained elusive. Furthermore, spine tilt and Cobb angle showed no significant differences from baseline to the 6th week. In conclusion, the application of thermotherapy coupled with twisting massage demonstrates significant efficacy in mitigating chronic non-specific spinal pain, surpassing the pain-relief outcomes achieved through heat therapy in combination with standard vibration massage techniques.

Investigating visual preferences of clinical mechanical anesthetic vibration: a cross-sectional image survey.

While mechanical vibration lessens discomfort associated with injection site pain (ISP), many local anesthetic injectors (LAIs) do not use vibratory anesthetic devices (VADs). Injector preference of vibration device is influenced by functional concerns, but qualitatively there is an element of adoption that is driven by visual feedback. We sought to capture operator preferences of vibration device design elements to further understand why injectors do not use these devices. We conducted a survey of image preferences among nurses and medical assistants employed at 8 dermatological clinics to investigate barriers to VAD use. Images were electronically modified with features distinct from the original device (a VAD commonly used in clinical practice). Participants rated their likelihood and comfort of use of each VAD represented in the images. Two-sample t-tests were used to compare the rating of the unmodified VAD to each modified VAD within participants. A response rate of 100% was achieved with 35 participants (average age, 38.5 years; 6 (17.1%) male, 29 (82.9%) female). Despite 28 (80%) participants knowing that mechanical vibration reduces ISP, only 16 (45.7%) endorsed ever using mechanical vibration as topical anesthetic. Images modified by pattern, color, and sterility covering were rated significantly lower than the original, unmodified VAD image (plain white VAD), confirming that visual feedback does impact adoption. Through independent comment categorization, aesthetics were found to be important to LAIs. Aesthetic preferences opposing functional concerns may factor into the lack of VAD use. Defining these visual preference barriers to adoption may help promote VAD use during dermatologic procedures.

Does whole-body vibration improve risk of falls, balance, and heart rate variability in post-COVID-19 patients? A randomized clinical trial.

INTRODUCTION: Whole-Body Vibration (WBV) can be a therapeutic recovery strategy for patients hospitalized for COVID-19. OBJECTIVES: To evaluate the effects of a 36-session WBV protocol on the risk of falls, balance, mobility and heart rate variability (HRV). STUDY DESIGN: A randomized clinical trial. METHODS: 13 patients affected by COVID-19, trained with WBV, 3×/week on alternate days, totaling 36 sessions, were evaluated before and after the intervention. RESULTS: WBV training at 2 mm and 4 mm amplitude resulted in a reduction in the risk of falls when compared to Sham (p = 0.023), with effect size of 0.530. No changes were observed for mobility and balance outcomes (p = 0.127) or for any of the HRV variables (p = 0.386). CONCLUSION: WBV training reduced the risk of falls in post-COVID patients. No changes were observed regarding balance and mobility, nor for HRV.

Effect of whole-body vibration frequency on objective physical function outcomes in healthy young adults: Randomized clinical trial.

INTRODUCTION: Whole-body vibration (WBV) is used to improve muscle function but is important to know if doses can affect the objective function outcomes. OBJECTIVE: To compare the effect of two frequencies of WBV on objective physical function outcomes in healthy young adults. METHODS: Forty-two volunteers were randomized into three groups: sham group (SG), and WBV groups with 30 (F30) and 45 Hz (F45). A 6-week WBV intervention protocol was applied by a vibrating platform twice a week, with the platform turn-off for SG and with two frequencies according to group, 30 or 45 Hz. The objective physical functions outcomes assessed were the proprioceptive accuracy, measured by proprioceptive tests, and quasi-static and dynamic balances, measured by Sensory Organization Test (SOT) and Y Balance Test, respectively. The outcomes were assessed before and after the WBV intervention. We used in the results comparisons, by GzLM test, the deltas percentage. RESULTS: After the intervention, no statistical differences were observed in percentage deltas for any outcomes (proprioceptive accuracy, quasi-static and dynamic balances). CONCLUSION: Objective physical function outcomes, after the 6-week WBV protocol, did not present statistically significant results in any of the intervention groups (F30 or F45) and SG.

The effect of whole-body vibration on glucose and lipid profiles in type-2 diabetes: a systematic review and pairwise and network meta-analyses of randomized trials.

Whole-body vibration (WBV), a training method based on the stimulation of muscle contraction by mechanical vibration generated in a vibrating platform, is claimed to be effective in diabetes management. This meta-analysis evaluated WBV effects against other exercises, placebo, or no intervention in type-2 diabetes. Medline, Scopus, and Web of Science databases were systematically searched through June 2023. Randomized controlled trials reported the effect of WBV on glucose (hemoglobin A1C and fasting blood glucose), and lipid profiles (total cholesterol, triglycerides, high, and low-density lipoprotein) were included. Two researchers independently extracted the characteristics of the studies, participants, WBV intervention and comparisons, and the outcomes from the included articles. The Physiotherapy Evidence Database (PEDro) scale assessed trial quality. In this review, all articles had no high risk of bias according to the PEDro scale, with studies achieving optimal, excellent, and good scores. Network meta-analysis revealed that WBV was effective for reducing hemoglobin A1C when compared with conventional (mean difference: - 1.58%, 95%CrI: - 2.51, - 0.47) and resistance exercise (mean difference: - 1.32%, 95%CrI: - 1.96, - 0.33). WBV had also a desirable but insignificant effect on hemoglobin A1C compared to stretching and balance exercises, placebo, and no intervention. The current pairwise meta-analysis did not show that WBV favors fasting blood glucose and lipids. WBV may have potential advantages for glycemic control in type-2 diabetes. However, uncertainties in the findings remain due to the limited number of studies and their heterogeneity.

Retention of Improved Plantar Sensation in Patients with Type II Diabetes Mellitus and Sensory Peripheral Neuropathy after One Month of Vibrating Insole Therapy: A Pilot Study.

Sensory peripheral neuropathy is a common complication of diabetes mellitus and the biggest risk factor for diabetic foot ulcers. There is currently no available treatment that can reverse sensory loss in the diabetic population. The application of mechanical noise has been shown to improve vibration perception threshold or plantar sensation (through stochastic resonance) in the short term, but the therapeutic use, and longer-term effects have not been explored. In this study, vibrating insoles were therapeutically used by 22 participants, for 30 min per day, on a daily basis, for a month by persons with diabetic sensory peripheral neuropathy. The therapeutic application of vibrating insoles in this cohort significantly improved VPT by an average of 8.5 V (p = 0.001) post-intervention and 8.2 V (p < 0.001) post-washout. This statistically and clinically relevant improvement can play a role in protection against diabetic foot ulcers and the delay of subsequent lower-extremity amputation.

Acute resistance exercise combined with whole body vibration and blood flow restriction: Molecular and neurocognitive effects in late-middle-aged and older adults.

Limited research exists regarding the effects of resistance exercise (RE) combined with whole body vibration (WBV), blood flow restriction (BFR), or both on the neuropsychological performance of working memory (WM) in late-middle-aged and older adults and regarding the physiological mechanisms underlying this effect. This study thus explored the acute molecular and neurophysiological mechanisms underlying WM performance following RE combined with WBV, BFR, or both. Sixty-six participants were randomly assigned into a WBV, BFR, or WBV + BFR group. Before and after the participants engaged in a single bout of isometric RE combined with WBV, BFR, or both, this study gathered data on several neurocognitive measures of WM performance, namely, accuracy rate (AR), reaction time (RT), and brain event-related potential (specifically P3 latency and amplitude), and data on biochemical indices, such as the levels of insulin-like growth factor-1 (IGF-1), norepinephrine (NE), and brain-derived neurotrophic factor (BDNF). Although none of the RE modalities significantly affected RTs and P3 latencies, ARs and P3 amplitudes significantly improved in the WBV and WBV + BFR groups. The WBV + BFR group exhibited greater improvements than the WBV group did. Following acute RE combined with WBV, BFR, or both, IGF-1 and NE levels significantly increased in all groups, whereas BDNF levels did not change. Crucially, only the changes in NE levels were significantly correlated with improvements in ARs in the WBV + BFR and WBV groups. The findings suggest that combining acute RE with WBV, BFR, or both could distinctively mitigate neurocognitive decline in late-middle-aged and older adults.

An abdominal vibration combined with walking exercise (AVCWE) program for older patients with constipation: Development and feasibility study.

BACKGROUND: Older patients with constipation are at higher risk for inadequate bowel preparation, but there are currently no targeted strategies. This study aims to develop an abdominal vibration combined with walking exercise (AVCWE) program and assess its feasibility among older patients with constipation. METHODS: Phase I: Using the Delphi technique, eight experts across three professional fields were consulted to develop the AVCWE program. The experts evaluated and provided recommendations on demonstration videos and detailed descriptions of the preliminary protocol. Phase II: A single-arm feasibility study of the AVCWE program was conducted on 30 older patients with constipation undergoing colonoscopy at a tertiary hospital in China. A 10-point exercise program evaluation form and several open-ended questions were used to gather feedback from participants regarding the program. In both phases, content analysis was used to critically analyze and summarize qualitative suggestions for protocol modifications. RESULTS: Based on feedback from the expert panel, the AVCWE program developed in Phase I included two procedures during laxative ingestion: at least 5,500 steps of walking exercise and two cycles of moderate-intensity abdominal vibration (each cycle consisted of 10 min of vibration and 10 min of rest). The feasibility study in Phase II showed high positive patient feedback scores for the program, ranging from 9.07 ± 0.74 to 9.73 ± 0.52. CONCLUSION: The AVCWE program was developed by eight multidisciplinary experts and was well accepted by 30 older patients with constipation. Study participants believed that this program was simple, safe, appropriate, and helpful for their bowel preparation. The findings of this study may provide valuable information for optimizing bowel preparation in older patients with constipation.

Effectiveness of low frequency vibration on the rate of canine retraction: a randomized controlled clinical trial.

To investigate the effectiveness of AcceleDent Aura vibrating device on the rate of canine retraction. Thirty-two patients requiring extraction of upper first premolars and canine retraction were randomly allocated with a 1:1 ratio into either no-appliance group or the AcceleDent Aura appliance group. Canine retraction was done applying 150gm of retraction force using NiTi coil springs on 16 × 22 stainless steel archwires. The duration of the study was 4 months. Models were collected and digitized directly after extraction of upper first premolars and at monthly intervals during canine retraction for recording the monthly as well as the total distance moved by the canine. Digitized models were superimposed on the initial model and data were statistically analyzed. Anchorage loss, rotation, tipping, torque and root condition were evaluated using cone beam computed tomography imaging. Pain was evaluated by visual analog scale. No patients were dropped-out during this study. There was no statistically significant difference between both groups regarding the total distance travelled by the canine (P = 0.436), as well as the rate of canine retraction per month (P = 0.17). Root condition was the same for the two groups. Regarding the pain level, there was no statistically significant difference between the two groups at day 0 (P = 0.721), after 24 h (P = 0.882), after 72 h (P = 0.378) and after 7 days (P = 0.964). AcceleDent Aura was not able to accelerate orthodontic tooth movement. Pain level couldn't be reduced by vibrational force with an AcceleDent device during orthodontic treatment. Root condition was not affected by the vibrational forces.

The Role of Vibrators in Women's Pelvic Health: An Alluring Tool to Improve Physical, Sexual, and Mental Health.

INTRODUCTION AND HYPOTHESIS: In limited studies vibrators have been shown to improve sexual function and pelvic floor health; however, there are even fewer studies on the effect of vibrator use on overall genitourinary and mental health. To investigate the effect of regular vibrator use on sexual, genitourinary, and mental health in addition to quality of life. METHODS: We performed a prospective pilot study of women aged 18 to 80 years recruited from a urogynecology clinic. Study participants were instructed to use a vibrator according to the protocol. Sexual function, pelvic floor function, mental health, and pelvic examination were assessed at the initial visit and at 3 months' follow-up using validated questionnaires. RESULTS: Of the 79 participants enrolled in the study, 53 women (66%) completed the study. The mean age of the participants was 54.7 years (range 19-80 years), and the majority of participants were white (n = 59, 74.7%), post-menopausal (n = 48, 60.8%), and not receiving systemic (n = 63, 79.7%) or local (n = 63, 79.7%) hormone therapy. Sexual function significantly improved over time (p = 0.002), whereas the rate of bothersome pelvic organ prolapse symptoms and pain scores significantly decreased (p = 0.034 and 0.0008 respectively). Rates of urge urinary incontinence decreased although this was not statistically significant (p = 0.059). There was a significant improvement in the gross appearance of lichen sclerosus lesions (p = 0.025) and in the severity of vaginal atrophy (p = 0.018). Rates of depression were significantly decreased (p = 0.011). CONCLUSIONS: Vibrator use was associated with improved sexual, genitourinary, and mental health.

Effects of 12 weeks of inspiratory muscle training and whole body vibration on the inflammatory profile, BDNF and muscular system in pre-frail elderly women: A randomized controlled trial.

AIM: to investigate the effects of the whole body vibration (WBV) and inspiratory muscle training (IMT) on the inflammatory profile and in muscle mass and strength in pre-frail older women. METHODS: this study was a randomized double-blind trial. Forty two older women aged 60-80 years were randomly allocated to IMT + WBV (G1), IMTsham + WBV (G2) or Sham groups (G3). During 12 weeks G1 received both trainings, whereas G2 received WBV alone and G3 received IMT with a low fixed load and were positioned at the vibratory platform without therapeutic effect. Participants were evaluated before and after the intervention for the following outcomes: Brain-derived neurotrophic factor (BDNF) and inflammatory biomarkers (IB), respiratory (RT) and quadriceps thickness (QT) and diaphragmatic mobility (DM) using muscle ultrasound, body composition (BC) using a bioelectrical impedance scale and inspiratory muscle strength (IMS). RESULTS: after the training, G1 (114.93 ± 21.29) improved IMS (p<0.005) compared with G2 (91.29 ± 23.10) and G3 (85.21 ± 27.02). There was also a significant improve on time of the DM (p<0.001) and RT (p=0.006) for G1 (8.59 ± 3.55 and 11.11 ± 12.66) compared with G2 (1.05 ± 3.09 and 1.10 ± 10.60) and G3 (0.40 ± 2.29 and -1.85 ± 7.45). BDNF, IB, QT and BC were similar between groups. CONCLUSIONS: IMT associated with WBV is effective to improve in increasing IMS, RT and DM in pre-frail older women. However, these interventions do not modify BDNF, IB, QT or BC in this population.

Color VISION for improved ultrasound visualization of brachytherapy needles.

BACKGROUND: High dose rate brachytherapy is commonly used in the treatment of prostate cancer. Treatment planning is often performed under transrectal ultrasound (US) guidance, but brachytherapy needles can be challenging to digitize due to the presence of poor US conspicuity and imaging artifacts. The plan accuracy and quality, however, are dependent on the proper visualization of the needles with millimeter accuracy. PURPOSE: This work describes a technique for generating a color overlay of needle locations atop the grayscale US image. Prototype devices were developed to produce vibrations in the brachytherapy needles that generate a high contrast color Doppler (CD) signal that highlights the needle locations with superior contrast and reduced artifacts. Denoted by the acronym color VISION (Vibrationally Induced Shimmering for Identifying an Object's Nature), the technology has the potential to improve applicator conspicuity and facilitate automated applicator digitization. METHODS: Three prototype vibrational devices with frequencies between 200-450 Hz were designed in-house and evaluated with needle implants in a phantom and cadaveric male pelvis using: (1) an actuator attached to the front of a prostate needle template; (2) an actuator attached to the top of the needle template; and (3) a hand-held actuator with a stylet, inserted directly into a needle's inner lumen. Acquired images were postprocessed in MATLAB to evaluate the potential for automated digitization. RESULTS: All prototype devices produced localized shimmering in implanted brachytherapy needles in both the axial and sagittal planes. The template mounted actuators provided better vibrational coupling and ease of operation than the stylet prototype. The Michelson contrast, or visibility, of the shimmering CD signal was 100% compared with ≤40% for B-mode imaging of a single needle. Proof-of-principle for automated applicator digitization using only the CD signal was demonstrated. CONCLUSIONS: The color VISION prototype devices successfully coupled mechanical vibrations into brachytherapy needles to generate US CD shimmering and accurately highlight brachytherapy needle locations. The high contrast and natively registered signal are promising for future work to automate the needle digitization and provide a real-time visual overlay of the applicator on the B-mode US image.

Effect of whole-body vibration stimulation on plasma soluble TNF receptors in elderly with sarcopenia: a randomized controlled trial.

Sarcopenia is a pathology resulting from a progressive and severe loss of muscle mass, strength, and function in the course of aging, which has deleterious consequences on quality of life. Among the most widespread studies on the issue are those focused on the effect of different types of physical exercise on patients with sarcopenia. This randomized controlled study aimed to compare the effects of a whole-body vibration exercise (WBV) session on the inflammatory parameters of non-sarcopenic (NSG, n=22) and sarcopenic elderly (SG, n=22). NSG and SG participants were randomly divided into two protocols: intervention (squat with WBV) and control (squat without WBV). After a one-week washout period, participants switched protocols, so that everyone performed both protocols. Body composition was assessed by dual-energy radiological absorptiometry (DXA) and function through the six-minute walk test (6MWD) and Short Physical Performance Battery (SPPB). Plasma soluble tumor necrosis factor receptors (sTNFR) were determined by enzyme-linked immunosorbent assay (ELISA) and measured before and immediately after each protocol. After exercise with WBV, there was an increase in sTNFR2 levels in the NSG (P<0.01; d=-0.69 (-1.30; -0.08) and SG (P<0.01, d=-0.95 (-1.57; -0.32) groups. In conclusion, an acute session of WBV influenced sTNFr2 levels, with sarcopenic individuals showing a greater effect. This suggested that WBV had a more pronounced impact on sTNFr2 in those with loss of muscle strength and/or physical performance. Additionally, WBV is gaining recognition as an efficient strategy for those with persistent health issues.

The effects of vibrating shoe insoles on standing balance, walking, and ankle-foot muscle activity in adults with diabetic peripheral neuropathy.

BACKGROUND: Peripheral neuropathy is one of the most common complications of type 2 diabetes, which can lead to impaired balance and walking. Innovative footwear devices designed to stimulate foot sensory receptors, such as vibrating insoles, could offer a new route to improve motor impairments in people with diabetic peripheral neuropathy (DPN). RESEARCH QUESTION: Does wearing vibrating insoles for the first time alter measures of balance, walking, and ankle-foot muscle activity, in people with DPN? METHODS: A randomised cross-over study was conducted with 18 ambulant men and women with a diagnosis of DPN. Participants performed tests of standing balance (Bertec® force platform) under four conditions (foam/firm surface, eyes open/closed) and level-ground walking (GAITRite® instrumented walkway), whilst wearing vibrating and non-vibrating (control) insoles on two separate occasions (one insole/session). Electromyography (EMG) was used to assess soleus, medial gastrocnemius, tibialis anterior, peroneus longus activity during balance tests. Outcomes included centre of pressure (CoP) sway, EMG amplitude, spatiotemporal gait patterns, and Timed Up and Go test. One sample t-tests were used to explore %differences in outcomes between insole conditions. RESULTS: Wearing vibrating insoles led to a reduction (improvement) in CoP elliptical area, when standing on a foam surface with eyes closed, relative to non-vibrating insoles (P=0.03). Applying perceptible vibrations to the soles of the feet also reduced the EMG amplitude in soleus (P=0.01 and P=0.04) and medial gastrocnemius (P=0.03 and P=0.09) when standing with eyes closed on firm and foam surfaces. SIGNIFICANCE: Our findings of signs of improved balance and altered muscle activity with suprasensory vibrating insoles provides new insights into how these devices can be used to inform innovative rehabilitation approaches in individuals with DPN. This will be strengthened by further research into possible clinical benefits of these devices - given that the effects we detected were small with uncertain clinical meaning.

The Effect of a Combination of Vibration and External Cold on Pain Caused during Vaccine Injection in Infants: A Randomized Clinical Trial.

Aim: This study was conducted to determine the effect of combining vibration and external cold on pain caused by vaccine injection among six-month-old infants. Design: Randomized controlled trial. Methods: In this clinical trial, 80 eligible infants were selected from the infants referred to a health center as per the inclusion criteria. The infants were assigned to either a control group or an intervention group by block randomization. In the intervention group, a vibrating and cold device was placed above the injection site from one minute before to 15 seconds after the pentavalent vaccine injection. In the control group, no intervention was performed, and they were vaccinated according to the routine procedure. The pain status in the two groups was measured using the Modified Behavioral Pain Scale (MBPS) 15 seconds after the injection, and the crying duration was assessed from the injection of the vaccine till the end of it. Data were analyzed in SPSS 23 software using Mann-Whitney, t, Spearman, and chi-square tests. The level of significance was set to p < 0.05. Results: Most participants in the control (55%) and intervention (55%) groups were girls. Statistical data analysis of 80 infants showed that the mean pain intensity (p = 0.032) and duration of crying (p = 0.0001) in the intervention group (6.1 ± 1.8, 32.47 ± 16.78) were lower than those of the control group (7.2 ± 0.1, 51.02 ± 25.9), respectively. Conclusion: Because the intensity of pain, especially the duration of crying, was lower in the intervention group than in the control group, we may suggest that nurses use simple pain relief solutions in vaccination centers, such as a combination of vibration and cold. This trial is registered with IRCT201207157130N2.