Dataset Information

The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial.

ABSTRACT: Background:Sensory peripheral neuropathy (PN) is associated with gait, balance problems and high fall risk. The walk2Wellness trial investigates effects of long-term, home-based daily use of a wearable sensory prosthesis on gait function, balance, quality of life and fall rates in PN patients. The device (Walkasins®, RxFunction Inc., MN, United States) partially substitutes lost nerve function related to plantar sensation providing directional tactile cues reflecting plantar pressure measurements during standing and walking. We tested the null hypothesis that the Functional Gait Assessment (FGA) score would remain unchanged after 10 weeks of use. Methods:Participants had PN with lost plantar sensation, gait and balance problems, an FGA score < 23 (high fall risk), and ability to sense tactile stimuli above the ankle. Clinical outcomes included FGA, Gait Speed, Timed Up&Go (TUG) and 4-Stage Balance Test. Patient-reported outcomes included Activities-Specific Balance Confidence (ABC) scale, Vestibular Disorders Activities of Daily Living Scale, PROMIS participation and satisfaction scores, pain rating, and falls. Evaluations were performed at baseline and after 2, 6, and 10 weeks. Subjects were not made aware of changes in outcomes. No additional balance interventions were allowed. Results:Forty-five participants of 52 enrolled across four sites completed in-clinic assessments. FGA scores improved from 15.0 to 19.1 (p < 0.0001), normal and fast gait speed from 0.86 m/s to 0.95 m/s (p < 0.0001) and 1.24 m/s to 1.33 m/s (p = 0.002), respectively, and TUG from 13.8 s to 12.5 s (p = 0.012). Four-Stage Balance Test did not improve. Several patient-reported outcomes were normal at baseline and remained largely unchanged. Interestingly, subjects with baseline ABC scores lower than 67% (high fall risk cut-off) increased their ABC scores (49.9% to 59.3%, p = 0.01), whereas subjects with ABC scores above 67% showed a decrease (76.6% to 71.8%, p = 0.019). Subjects who reported falls in the prior 6 months (n = 25) showed a decrease in the number of fall-risk factors (5.1 to 4.3, p = 0.023) and a decrease in fall rate (13.8 to 7.4 falls/1000 days, p = 0.014). Four pre-study non-fallers (n = 20) fell during the 10 weeks. Conclusion:A wearable sensory prosthesis presents a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN. Trial registration:ClinicalTrials.gov (#NCT03538756).

SUBMITTER: Oddsson LIE

PROVIDER: S-EPMC7680959 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial.

Oddsson Lars I E LIE Bisson Teresa T Cohen Helen S HS Jacobs Laura L Khoshnoodi Mohammad M Kung Doris D Lipsitz Lewis A LA Manor Brad B McCracken Patricia P Rumsey Yvonne Y Wrisley Diane M DM Koehler-McNicholas Sara R SR

Frontiers in aging neuroscience 20201109

<h4>Background</h4>Sensory peripheral neuropathy (PN) is associated with gait, balance problems and high fall risk. The walk2Wellness trial investigates effects of long-term, home-based daily use of a wearable sensory prosthesis on gait function, balance, quality of life and fall rates in PN patients. The device (Walkasins<sup>®</sup>, RxFunction Inc., MN, United States) partially substitutes lost nerve function related to plantar sensation providing directional tactile cues reflecting plantar p ...[more]

PMID: 33240077

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Project description:Motor functions are deteriorated by aging. Some conditions may magnify this deterioration. This study examined whether hemodialysis (HD) process would negatively impact gait and balance beyond diabetes condition among mid-age adults (48⁻64 years) and older adults (65+ years). One hundred and ninety-six subjects (age = 66.2 ± 9.1 years, body-mass-index = 30.1 ± 6.4 kg/m², female = 56%) in 5 groups were recruited: mid-age adults with diabetes undergoing HD (Mid-age HD+, n = 38) and without HD (Mid-age HD-, n = 40); older adults with diabetes undergoing HD (Older HD+, n = 36) and without HD (Older HD-, n = 37); and non-diabetic older adults (Older DM-, n = 45). Gait parameters (stride velocity, stride length, gait cycle time, and double support) and balance parameters (ankle, hip, and center of mass sways) were quantified using validated wearable platforms. Groups with diabetes had overall poorer gait and balance compared to the non-diabetic group (p < 0.050). Among people with diabetes, HD+ had significantly worsened gait and balance when comparing to HD- (Cohen's effect size d = 0.63⁻2.32, p < 0.050). Between-group difference was more pronounced among older adults with the largest effect size observed for stride length (d = 2.32, p < 0.001). Results suggested that deterioration in normalized gait speed among HD+ was negatively correlated with age (r = -0.404, p < 0.001), while this correlation was diminished among HD-. Interestingly, results also suggested that poor gait among Older HD- is related to poor ankle stability, while no correlation was observed between poor ankle stability and poor gait among Older HD+. Using objective assessments, results confirmed that the presence of diabetes can deteriorate gait and balance, and this deterioration can be magnified by HD process. Among HD- people with diabetes, poor ankle stability described poor gait. However, among people with diabetes undergoing HD, age was a dominate factor describing poor gait irrespective of static balance. Results also suggested feasibility of using wearable platforms to quantify motor performance during routine dialysis clinic visit. These objective assessments may assist in identifying early deterioration in motor function, which in turn may promote timely intervention.

Project description:BackgroundClinicians are routinely required to make decisions about fall risk among lower limb prosthesis (LLP) users. These decisions can be guided by standardized clinical balance tests but require population- and test-specific cutoff scores and validity indices to categorize individuals as probable fallers or nonfallers on the basis of test performance. Despite the importance of cutoff scores and validity indices to clinical interpretation of clinical balance test scores, they are rarely reported for LLP users. In their absence, clinicians cannot use results from clinical balance tests to assess the likelihood of a fall by any one patient.ObjectiveDerive cutoff scores, and associated validity indices, for clinical balance tests administered to established unilateral LLP users.DesignCross-sectional study.SettingOutpatient clinic and research laboratory.ParticipantsEstablished ambulatory unilateral transtibial and transfemoral prosthesis users (n?=?40).InterventionNot applicable.Main outcome measure(s)Optimal cutoff scores and related validity indices (ie, area under the curve, sensitivity, specificity, likelihood ratios) were computed for five balance tests, the activities-specific balance confidence scale (ABC), timed up and go (TUG), four square step test (FSST), Berg balance scale (BBS), and narrowing-beam walking test (NBWT).ResultsCutoff scores were identified for the NBWT (?.43/1.0), TUG (?8.17?seconds], FSST (?8.49 seconds), BBS (?50.5/56), and ABC (?80.2/100). Validity indices (ie, area under the curve, sensitivity, specificity, and likelihood ratios) for the NBWT, TUG, and FSST had greater diagnostic accuracy and provided more information about the probability of a fall than those for the BBS or ABC.ConclusionPerformance above or below identified cutoff scores for the NBWT, FSST, and TUG provides information about potentially important shifts in the probability of falling among established unilateral LLP users. These results can serve as initial benchmarks to reduce uncertainty surrounding fall risk assessment in established unilateral LLP users but require future prospective evaluation.Level of evidenceIII.

Project description:AIM:The main purpose of the present study was to verify the feasibility of wearable inertial sensors (IMUs) in a clinical setting to screen gait and functional mobility in Italian older persons. In particular, we intended to verify the capability of IMUs to discriminate individuals with and without cognitive impairments and assess the existence of significant correlations between mobility parameters extracted by processing trunk accelerations and cognitive status. METHODS:This is a cross-sectional study performed on 213 adults aged over 65 years (mean age 77.0?±?5.4; 62% female) who underwent cognitive assessment (through Addenbrooke's Cognitive Examination Revised, ACE-R) instrumental gait analysis and the Timed Up and Go (TUG) test carried out using a wearable IMU located in the lower back. RESULTS:Individuals with cognitive impairments exhibit a peculiar gait pattern, characterized by significant reduction of speed (-?34% vs. healthy individuals), stride length (-?28%), cadence (-?9%), and increase in double support duration (+?11%). Slight, but significant changes in stance and swing phase duration were also detected. Poorer performances in presence of cognitive impairment were observed in terms of functional mobility as overall and sub-phase TUG times resulted significantly higher with respect to healthy individuals (overall time,?+?38%, sub-phases times ranging from?+?22 to?+?34%), although with some difference associated with age. The severity of mobility alterations was found moderately to strongly correlated with the ACE-R score (Spearman's rho?=?0.58 vs. gait speed, 0.54 vs. stride length, 0.66 vs. overall TUG time). CONCLUSION:The findings obtained in the present study suggest that wearable IMUs appear to be an effective solution for the clinical assessment of mobility parameters of older persons screened for cognitive impairments within a clinical setting. They may represent a useful tool for the clinician in verifying the effectiveness of interventions to alleviate the impact of mobility limitations on daily life in cognitively impaired individuals.

Project description:Poor balance control and increased fall risk have been reported in people with diabetic peripheral neuropathy (DPN). Traditional body sway measures are unable to describe underlying postural control mechanism. In the current study, we used stabilogram diffusion analysis to examine the mechanism under which balance is altered in DPN patients under local-control (postural muscle control) and central-control (postural control using sensory cueing). DPN patients and healthy age-matched adults over 55 years performed two 15-second Romberg balance trials. Center of gravity sway was measured using a motion tracker system based on wearable inertial sensors, and used to derive body sway and local/central control balance parameters. Eighteen DPN patients (age = 65.4±7.6 years; BMI = 29.3±5.3 kg/m2) and 18 age-matched healthy controls (age = 69.8±2.9; BMI = 27.0±4.1 kg/m2) with no major mobility disorder were recruited. The rate of sway within local-control was significantly higher in the DPN group by 49% (healthy local-controlslope = 1.23±1.06×10-2 cm2/sec, P<0.01), which suggests a compromised local-control balance behavior in DPN patients. Unlike local-control, the rate of sway within central-control was 60% smaller in the DPN group (healthy central-controlslope-Log = 0.39±0.23, P<0.02), which suggests an adaptation mechanism to reduce the overall body sway in DPN patients. Interestingly, significant negative correlations were observed between central-control rate of sway with neuropathy severity (rPearson = 0.65-085, P<0.05) and the history of diabetes (rPearson = 0.58-071, P<0.05). Results suggest that in the lack of sensory feedback cueing, DPN participants were highly unstable compared to controls. However, as soon as they perceived the magnitude of sway using sensory feedback, they chose a high rigid postural control strategy, probably due to high concerns for fall, which may increase the energy cost during extended period of standing; the adaptation mechanism using sensory feedback depends on the level of neuropathy and the history of diabetes.

Dataset Information

The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial.

Publications

The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial.

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