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Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors.

ABSTRACT: Peripheral sensory stimulation augments post-stroke upper extremity rehabilitation outcomes. Most sensory stimulations interfere with natural hand tasks and the stimulation duration is limited. We developed TheraBracelet, low-level random-frequency vibration applied via a wristwatch, to enable stimulation during hand tasks and potentially extend stimulation durations. To determine safety of prolonged exposure to TheraBracelet. Single-site double-blind crossover randomized controlled trial. Chronic stroke survivors were instructed to wear a device on the affected wrist for > 8 h/day everyday for 2 months while coming to the laboratory weekly for evaluations, with a 2-week break between each month. The device applied vibration at 60% and 1% of the sensory threshold for the real and sham month, respectively. The order of the real and sham months was randomized/balanced. Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling. Device-related AE rates were compared between the real and sham month. Twenty-five participants completed the study. Six participants (24%) experienced mild AEs involving worsened sensory scores that may be related to the intervention with reasonable possibility. Two experienced them in the real stimulation month only, 3 in the sham month only, and 1 in both months. Therefore, less participants experienced device-related AEs in the real than sham month. Daily stimulation using the device for a month is safe for chronic stroke survivors. Future studies examining the efficacy of pairing TheraBracelet with therapy for increasing neurorehabilitation outcomes are a logical next step. Trial registration: NCT03318341.

SUBMITTER: Seo NJ

PROVIDER: S-EPMC7035973 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: Huntington's disease (HD) leads to altered gait patterns and reduced daily-living physical activity. Accurate measurement of daily-living walking that takes into account involuntary movements (e.g. chorea) is needed. Objective: To evaluate daily-living gait quantity and quality in HD, taking into account irregular movements. Methods: Forty-two individuals with HD and fourteen age-matched non-HD peers completed clinic-based assessments and a standardized laboratory-based circuit of functional activities, wearing inertial measurement units on the wrists, legs, and trunk. These activities were used to train and test an algorithm for the automated detection of walking. Subsequently, 29 HD participants and 22 age-matched non-HD peers wore a tri-axial accelerometer on their non-dominant wrist for 7 days. Measures included gait quantity (e.g., steps per day), gait quality (e.g., regularity) metrics, and percentage of walking bouts with irregular movements. Results: Measures of daily-living gait quantity including step counts, walking time and bouts per day were similar in HD participants and non-HD peers (p > 0.05). HD participants with higher clinician-rated upper body chorea had a greater percentage of walking bouts with irregular movements compared to those with lower chorea (p = 0.060) and non-HD peers (p < 0.001). Even after accounting for irregular movements, within-bout walking consistency was lower in HD participants compared to non-HD peers (p < 0.001), while across-bout variability of these measures was higher (p < 0.001). Many of the daily-living measures were associated with disease-specific measures of motor function. Conclusions: Results suggest that a wrist-worn accelerometer can be used to evaluate the quantity and quality of daily-living gait in people with HD, while accounting for the influence of irregular (choreic-like) movements, and that gait features related to within- and across-bout consistency markedly differ in individuals with HD and non-HD peers.

Project description:IntroductionWrist-mounted motion sensors can quantify the volume and intensity of physical activities, but little is known about their long-term validity. Our aim was to validate a wrist motion sensor in estimating daily energy expenditure, including any change induced by long-term participation in endurance and strength training. Supplemental heart rate monitoring during weekly exercise was also investigated.MethodsA 13-day doubly labeled water (DLW) measurement of total energy expenditure (TEE) was performed twice in healthy male subjects: during two last weeks of a 12-week Control period (n = 15) and during two last weeks of a 12-week combined strength and aerobic Training period (n = 13). Resting energy expenditure was estimated using two equations: one with body weight and age, and another one with fat-free mass. TEE and activity induced energy expenditure (AEE) were determined from motion sensor alone, and from motions sensor combined with heart rate monitor, the latter being worn during exercise only.ResultsWhen body weight and age were used in the calculation of resting energy expenditure, the motion sensor data alone explained 78% and 62% of the variation in TEE assessed by DLW at the end of Control and Training periods, respectively, with a bias of +1.75 (p <.001) and +1.19 MJ/day (p = .002). When exercise heart rate data was added to the model, the combined wearable device approach explained 85% and 70% of the variation in TEE assessed by DLW with a bias of +1.89 and +1.75 MJ/day (p <.001 for both). While significant increases in TEE and AEE were detected by all methods as a result of participation in regular training, motion sensor approach underestimated the change measured by DLW: +1.13±0.66 by DLW, +0.59±0.69 (p = .004) by motion sensor, and +0.98±0.70 MJ/day by combination of motion sensor and heart rate. Use of fat-free mass in the estimation of resting energy expenditure removed the biases between the wearable device estimations and the golden standard reference method of TEE and demonstrated a training-induced increase in resting energy expenditure by +0.18±0.13 MJ/day (p <.001).ConclusionsWrist motion sensor combined with a heart rate monitor during exercise sessions, showed high agreement with the golden standard measurement of daily TEE and its change induced by participation in a long-term training protocol. The positive findings concerning the validity, especially the ability to follow-up the change associated with a lifestyle modification, can be considered significant because they partially determine the feasibility of wearable devices as quantifiers of health-related behavior.

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Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors.

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