The Effect of Implanted Functional Electrical Stimulation on Gait Performance in Stroke Survivors: A Systematic Review.

The emerging literature suggests that implantable functional electrical stimulation may improve gait performance in stroke survivors. However, there is no review providing the possible therapeutic effects of implanted functional electrical stimulation on gait performance in stroke survivors. We performed a web-based, systematic paper search using PubMed, the Cochrane Library, and EMBASE. We limited the search results to human subjects and papers published in peer-reviewed journals in English. We did not restrict demographic or clinical characteristics. We included 10 papers in the current systematic review. Across all included studies, we found preliminary evidence of the potential therapeutic effects of functional electrical stimulation on walking endurance, walking speed, ankle mobility, and push-off force in stroke survivors. However, due to the heterogeneity between the included studies, small sample size, and lack of randomized controlled trials, more studies are critically needed to confirm whether implanted functional electrical stimulation can improve gait performance in stroke survivors.

The Potential Role of Sensors, Wearables and Telehealth in the Remote Management of Diabetes-Related Foot Disease.

Diabetes-related foot disease (DFD), which includes foot ulcers, infection and gangrene, is a leading cause of the global disability burden. About half of people who develop DFD experience a recurrence within one year. Long-term medical management to reduce the risk of recurrence is therefore important to reduce the global DFD burden. This review describes research assessing the value of sensors, wearables and telehealth in preventing DFD. Sensors and wearables have been developed to monitor foot temperature, plantar pressures, glucose, blood pressure and lipids. The monitoring of these risk factors along with telehealth consultations has promise as a method for remotely managing people who are at risk of DFD. This approach can potentially avoid or reduce the need for face-to-face consultations. Home foot temperature monitoring, continuous glucose monitoring and telehealth consultations are the approaches for which the most highly developed and user-friendly technology has been developed. A number of clinical studies in people at risk of DFD have demonstrated benefits when using one of these remote monitoring methods. Further development and evidence are needed for some of the other approaches, such as home plantar pressure and footwear adherence monitoring. As yet, no composite remote management program incorporating remote monitoring and the management of all the key risk factors for DFD has been developed and implemented. Further research assessing the feasibility and value of combining these remote monitoring approaches as a holistic way of preventing DFD is needed.

Pilot study evaluating the efficacy of exergaming for the prevention of deep venous thrombosis.

OBJECTIVE: Current prophylactic protocols fail to prevent deep venous thrombosis (DVT) in a significant minority of patients, and it remains one of the leading causes of preventable death. We therefore quantified the efficacy of novel game-based exercises (exergaming) to augment femoral venous parameters relative to ankle movement and muscle flexion. METHODS: Healthy volunteers were recruited to perform a series of ankle and foot exercises using a wireless foot sensor (LEGSys; BioSensics LLC, Watertown, Mass) to navigate a computer cursor sequentially on a screen to the center of 200 circular targets. A single ultrasound technician (W.A.M.) measured each patient's mean flow volume, peak flow velocity, mean flow velocity, and cross-sectional area of the right femoral vein at baseline and obtained immediate postexercise (PEX), 5-minute PEX, and 15-minute PEX measurements. Electromyography (EMG) was performed at baseline and during the exercise. Baseline demographics and medical and surgical comorbidities were also recorded. The primary end point was the difference between baseline and immediate PEX mean flow volume estimates. We secondarily explored the association of baseline characteristics and EMG measurements with femoral vein parameters. RESULTS: Fifteen healthy subjects (53% male; 28.1 ± 4.6 years) completed the exergaming task within a mean of 4 minutes, 2 ± 21 seconds. Immediately after exercise, the femoral vein mean flow volume, mean velocity, and peak systolic velocity increased by 49%, 53%, and 48%, respectively (P < .02 for each). Mean flow volume and velocity remained significantly elevated 5 minutes after exercise (P < .04 for each). Plantar flexion and dorsiflexion velocities and EMG frequency and intensity were not significantly correlated with PEX mean flow volume estimates (P > .05). Subgroup analysis revealed that women (P < .01) and Hispanics (P < .01) exhibited significantly slower PEX responses. Subjects with the largest improvements in mean flow volume had lower peak plantar flexion velocities (P < .01). CONCLUSIONS: Exergaming increases mean flow volume, mean flow velocity, and peak systolic velocity within the femoral vein by approximately 50% above baseline. Exergaming represents a novel and potentially attractive method of DVT prevention by augmenting femoral vein mean volume flow and capitalizing on biofeedback. Less forceful but more uniform contractions were found to be most effective at augmenting venous blood flow. Exergaming will require further validation in larger study bases, among patients at higher risk of DVT.

Effects of Wearable Sensor-Based Balance and Gait Training on Balance, Gait, and Functional Performance in Healthy and Patient Populations: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Wearable sensors (WS) can accurately measure body motion and provide interactive feedback for supporting motor learning. OBJECTIVE: This review aims to summarize current evidence for the effectiveness of WS training for improving balance, gait and functional performance. METHODS: A systematic literature search was performed in PubMed, Cochrane, Web of Science, and CINAHL. Randomized controlled trials (RCTs) using a WS exercise program were included. Study quality was examined by the PEDro scale. Meta-analyses were conducted to estimate the effects of WS balance training on the most frequently reported outcome parameters. RESULTS: Eight RCTs were included (Parkinson n = 2, stroke n = 1, Parkinson/stroke n = 1, peripheral neuropathy n = 2, frail older adults n = 1, healthy older adults n = 1). The sample size ranged from n = 20 to 40. Three types of training paradigms were used: (1) static steady-state balance training, (2) dynamic steady-state balance training, which includes gait training, and (3) proactive balance training. RCTs either used one type of training paradigm (type 2: n = 1, type 3: n = 3) or combined different types of training paradigms within their intervention (type 1 and 2: n = 2; all types: n = 2). The meta-analyses revealed significant overall effects of WS training on static steady-state balance outcomes including mediolateral (eyes open: Hedges' g = 0.82, CI: 0.43-1.21; eyes closed: g = 0.57, CI: 0.14-0.99) and anterior-posterior sway (eyes open: g = 0.55, CI: 0.01-1.10; eyes closed: g = 0.44, CI: 0.02-0.86). No effects on habitual gait speed were found in the meta-analysis (g = -0.19, CI: -0.68 to 0.29). Two RCTs reported significant improvements for selected gait variables including single support time, and fast gait speed. One study identified effects on proactive balance (Alternate Step Test), but no effects were found for the Timed Up and Go test and the Berg Balance Scale. Two studies reported positive results on feasibility and usability. Only one study was performed in an unsupervised setting. CONCLUSION: This review provides evidence for a positive effect of WS training on static steady-state balance in studies with usual care controls and studies with conventional balance training controls. Specific gait parameters and proactive balance measures may also be improved by WS training, yet limited evidence is available. Heterogeneous training paradigms, small sample sizes, and short intervention durations limit the validity of our findings. Larger studies are required for estimating the true potential of WS technology.

Using Plantar Electrical Stimulation to Improve Postural Balance and Plantar Sensation Among Patients With Diabetic Peripheral Neuropathy: A Randomized Double Blinded Study.

OBJECTIVE: People with diabetic peripheral neuropathy (DPN) often exhibit deteriorations in motor-performance mainly due to lack of plantar-sensation. The study explored effectiveness of plantar electrical-stimulation therapy to enhance motor-performance among people with DPN. DESIGN AND METHODS: Using a double-blinded model, 28 volunteers with DPN (age: 57.8 ± 10.2 years) were recruited and randomized to either intervention (IG: n = 17) or control (CG: n = 11) group. Both groups received identical plantar-stimulation devices for six weeks of daily use at home; however, only the IG devices were set to deliver stimulation. Balance (ankle, hip, and center of mass [COM] sway) and gait (stride velocity [SV], stride time [ST], stride length [SL], and cadence) were measured using validated wearable sensors. Outcomes were assessed at baseline and at six-week. Clinical assessment including vascular as measured by ankle-brachial-index (ABI) and plantar-sensation as quantified by vibratory plantar threshold (VPT) were also measured at baseline and six weeks. RESULTS: No difference were observed between groups for baseline characteristics ( P > .050). Posttherapy, ankle and COM sway with eyes open were significantly improved ( P < .05, Cohen's effect size d = 0.67-0.76) in the IG with no noticeable changes in CG. All gait parameters were significantly improved in the IG with highest effect size observed for cadence ( d = 1.35, P = .000). Results revealed improvement in VPT ( P = .004, d = 1.15) with significant correlation with stride velocity improvement ( r = .56, P = .037). ABI was improved in the IG in particulate among those with ABI>1.20 ( P = .041, d = 0.99) Conclusion: This study suggests that daily home use of plantar electrical-stimulation may be a practical means to enhance motor-performance and plantar-sensation in people with DPN.

A Pilot Clinical Trial to Objectively Assess the Efficacy of Electroacupuncture on Gait in Patients with Parkinson's Disease Using Body Worn Sensors.

BACKGROUND: Gait disorder, a key contributor to fall and poor quality of life, represents a major therapeutic challenge in Parkinson's disease (PD). The efficacy of acupuncture for PD remains unclear, largely due to methodological flaws and lack of studies using objective outcome measures. OBJECTIVE: To objectively assess the efficacy of electroacupuncture (EA) for gait disorders using body-worn sensor technology in patients with PD. METHODS: In this randomized pilot study, both the patients and assessors were masked. Fifteen PD patients were randomly assigned to an experimental group (n = 10) or to a control group (n = 5). Outcomes were assessed at baseline and after completion of three weekly EA treatments. Measurements included gait analysis during single-task habitual walking (STHW), dual-task habitual walking (DTHW), single-task fast walking (STFW), dual-task fast walking (DTFW). In addition, Unified Parkinson's Disease Rating Scale (UPDRS), SF-12 health survey, short Falls Efficacy Scale-International (FES-I), and visual analog scale (VAS) for pain were utilized. RESULTS: All gait parameters were improved in the experimental group in response to EA treatment. After adjustment by age and BMI, the improvement achieved statistical significant level for gait speed under STHW, STFW, and DTFW (9%-19%, p<0.05) as well as stride length during DTFW (9%, p = 0.037) and midswing speed during STFW (6%, p = 0.033). No significant changes were observed in the control group (p>0.110). The highest correlation between gait parameters and UPRDS scores at baseline was observed between gait speed during STFW and UPDRS II (r = -0.888, p = 0.004). The change in this gait parameter in response to active intervention was positively correlated with baseline UPDRS (r = 0.595, p = 0.057). Finally, comparison of responses to treatment between groups showed significant improvement, prominently in gait speed (effect size 0.32-1.16, p = 0.001). CONCLUSIONS: This study provides the objective proof of concept for potential benefits of non-pharmaceutical based EA therapy on enhancing gait in patients with PD. TRIAL REGISTRATION: ClinicalTrials.gov NCT02556164.

New and Future Directions in Integrative Medicine Research Methods with a Focus on Aging Populations: A Review.

This review discusses existing and developing state-of-the-art noninvasive methods for quantifying the effects of integrative medicine (IM) in aging populations. The medical conditions of elderly patients are often more complex than those of younger adults, making the multifaceted approach of IM particularly suitable for aging populations. However, because IM interventions are multidimensional, it has been difficult to examine their effectiveness and mechanisms of action. Optimal assessment of IM intervention effects in the elderly should include a multifaceted approach, utilizing advanced analytic methods to integrate psychological, behavioral, physiological, and biomolecular measures of a patient's response to IM treatment. Research is presented describing methods for collecting and analyzing psychological data; wearable unobtrusive devices for monitoring heart rate variability, activity and other behavioral responses in real time; immunochemical methods for noninvasive molecular biomarker analysis, and considerations and analytical approaches for the integration of these measures. The combination of methods and devices presented in this review will provide new approaches for evaluating the effects of IM interventions in real-life ambulatory settings of older adults, and will extend the concept of mobile health to the domains of IM and healthy aging.

Treatment options for venous leg ulcers: effectiveness of vascular surgery, bioengineered tissue, and electrical stimulation.

OBJECTIVE: To evaluate the peer-reviewed literature that compares advanced venous leg ulcer therapies to standard of care with compression dressings. METHODS: A MEDLINE search for venous ulcer treatment with electrical stimulation, surgical vein correction, and bioengineered tissues was conducted. Randomized clinical trials comparing advanced treatment with standard of care using compression dressing were included. A total of 7 bioengineered tissue, 4 surgical treatment, and 4 electrical stimulation randomized clinical trials were identified. RESULTS: Compared with nonstandard treatments, electrical stimulation demonstrated improved wound healing, fewer adverse events, and shorter duration of healing. Healing rates at the end of the study were greater for surgical intervention, followed by similar outcomes for electrical stimulation and bioengineered tissues. Studies involving bioengineered tissues and surgical venous ablation demonstrated inconsistent/inconclusive results. CONCLUSIONS: Utilization of electrical stimulation in venous ulcer management has not been fully explored. Further studies of dosing electrical stimulation therapy may reveal therapeutic and preventive benefits for managing venous ulcers not yet elucidated.

Does integrative medicine enhance balance in aging adults? Proof of concept for the benefit of electroacupuncture therapy in Parkinson's disease.

BACKGROUND: Postural balance and potentially fall risk increases among older adults living with neurological diseases, especially Parkinson's disease (PD). Since conventional therapies such as levodopa or deep brain stimulation may fail to alleviate or may even worsen balance, interest is growing in evaluating alternative PD therapies. OBJECTIVE: The purpose of the current study was to assess improvement in postural balance in PD patients following electroacupuncture (EA) as an alternative therapy. METHODS: 15 aging adults (71.2 ± 6.3 years) with idiopathic PD and 44 healthy age-matched participants (74.6 ± 6.5 years) were recruited. The PD participants were randomly assigned (at a ratio of 2:1) to an intervention (n = 10) or to a control group (n = 5). The intervention group received a 30-min EA treatment on a weekly basis for 3 weeks, while the control group received a sham treatment. Outcomes were assessed at baseline and after the final therapy. Measurements included balance assessment, specifically the ratio of medial-lateral (ML) center-of-gravity (COG) sway to anterior-posterior (AP) sway (COGML/AP) and ankle/hip sway during eyes-open, eyes-closed, and eyes-open dual-task trials, the Unified Parkinson's Disease Rating Scale (UPDRS), as well as quality of life, concerns for fall, and pain questionnaires. RESULTS: No difference was observed for the assessed parameters between the intervention and the control group at baseline. After treatment, an improvement in balance performance was observed in the intervention group. Compared with the healthy population, PD patients prior to treatment had larger COGML/AP sway with more dependency on upper-body movements for maintaining balance. Following EA therapy, COGML/AP sway was reduced by 31% and ankle/hip sway increased by 46% in the different conditions (p = 0.02 for the dual-task condition). The clinical rating revealed an overall improvement (p < 0.01) in mentation, behavior, and mood (UPDRS part I, 49%), activities of daily living (UPDRS part II, 46%), and motor examination (UPDRS part III, 40%). There was a significant reduction (p < 0.02) in the specific items regarding UPDRS fall status (67%) and rigidity (48%). Changes were small and nonsignificant in the controls (p > 0.29). CONCLUSIONS: This pilot study demonstrates improvement in rigidity and balance following EA. These preliminary results suggest EA could be a promising alternative treatment for balance disturbance in PD.

Effect of Tai Chi on physical function, fall rates and quality of life among older stroke survivors.

OBJECTIVE: To examine the effect of a 12-week Tai Chi (TC) intervention on physical function and quality of life. DESIGN: Single-blind, randomized controlled trial. SETTING: General community. PARTICIPANTS: Community-dwelling survivors of stroke (N=145; 47% women; mean age, 70y; time poststroke: 3y; ischemic stroke: 66%; hemiparesis: 73%) who were aged ≥50 years and were ≥3 months poststroke. INTERVENTIONS: Yang style 24-posture short-form TC (n=53), strength and range of movement exercises (SS) (n=44), or usual care (UC) (n=48) for 12 weeks. The TC and SS groups attended a 1-hour class 3 times per week, whereas the UC group had weekly phone calls. MAIN OUTCOME MEASURES: Physical function: Short Physical Performance Battery, fall rates, and 2-minute step test; quality of life: Medical Outcomes Study 36-Item Short-Form Health Survey, Center for Epidemiologic Studies Depression Scale, and Pittsburgh Sleep Quality Index. RESULTS: During the intervention, TC participants had two thirds fewer falls (5 falls) than the SS (14 falls) and UC (15 falls) groups (χ(2)=5.6, P=.06). There was a significant group by time interaction for the 2-minute step test (F2,142=4.69, P<.01). Post hoc tests indicated that the TC (t53=2.45, P=.02) and SS (t44=4.63, P<.01) groups had significantly better aerobic endurance over time, though not in the UC group (t48=1.58, P=.12). Intervention adherence rates were 85%. CONCLUSIONS: TC and SS led to improved aerobic endurance, and both are suitable community-based programs that may aid in stroke recovery and community reintegration. Our data suggest that a 12-week TC intervention was more effective in reducing fall rates than SS or UC interventions. Future studies examining the effectiveness of TC as a fall prevention strategy for community-dwelling survivors of stroke are recommended.

Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy.

BACKGROUND: The objective of this review is to evaluate the use of electrical stimulation to treat diabetic neuropathy. Application of electrical stimulation may provide a novel treatment option for large and small fiber neuropathy in persons with diabetes. Large and small nerve neuropathy alters pain, proprioception, touch perception, and motor function, which cause burning foot pain and serve as protective mechanisms from ulcerations. METHODS: A content search for clinical trials involving electrical stimulation, neuropathy, and diabetes was conducted through PubMed. Randomized clinical trials and prospective studies with outcome measures affecting the lower extremity function were selected for review. RESULTS: We identified eight studies in which electrical stimulation was used to treat diabetic neuropathy. Six studies evaluated small fiber neuropathy. Two studies evaluated patients with both small and large fiber neuropathy and reported significant improvement in vibration and monofilament testing and reduction in symptoms in the electrical stimulation treatment group. Six of the eight painful neuropathy studies identified significant improvement in symptoms. There were no studies that evaluated electrical stimulation to treated diabetic motor neuropathy, fall prevention or postural instability. CONCLUSIONS: Electrical stimulation may be an effective alternative and adjunctive therapy to current interventions for diabetic peripheral neuropathy.

A novel plantar stimulation technology for improving protective sensation and postural control in patients with diabetic peripheral neuropathy: a double-blinded, randomized study.

BACKGROUND: Many diabetes-related peripheral neuropathy (DPN) patients also experience postural instability. OBJECTIVE: This study examined the effect of electrical stimulation therapy on DPN patients' postural control as well as recovery of plantar sensation. METHODS: 54 patients with mild to moderate DPN were enrolled into this study evaluating treatment of DPN with electrical stimulation provided via aqueous solution. The subjects were randomized into either sham or active stimulation. Treatments were administered 5 times per week for 6 weeks. Changes in neuropathy severity were assessed via Semmes-Weinstein monofilament tests and vibration perception threshold (VPT) tests. The potential benefit in postural control was assessed in a subsample of 13 subjects by measuring the area of center of mass (COM) sway. RESULTS: The active group saw a significant (p < 0.05) improvement in VPT at treatment week 6 in comparison to the sham group. The difference did not remain significant at follow-up visits. There were no significant differences between groups for the Semmes-Weinstein monofilament test. However, time was a significant main effect, with both groups improving over the course of the study. The area of COM sway was significantly reduced on average by 36% at treatment week 2 compared to the baseline. Although at treatment week 6 an additional 7% reduction in COM sway was observed compared to treatment week 2, the improvement from treatment week 2 to treatment week 6 was not significant (p > 0.6). Interestingly, no significant difference was observed in the sham group during the study (p > 0.7). CONCLUSION: This randomized pilot study provides preliminary data on the potential of electrical stimulation via aqueous solution to improve protective sensation and postural stability in DPN patients.