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SIRRACT: An International Randomized Clinical Trial of Activity Feedback During Inpatient Stroke Rehabilitation Enabled by Wireless Sensing.

ABSTRACT: Walking-related disability is the most frequent reason for inpatient stroke rehabilitation. Task-related practice is a critical component for improving patient outcomes.To test the feasibility of providing quantitative feedback about daily walking performance and motivating greater skills practice via remote sensing.In this phase III randomized, single blind clinical trial, patients participated in conventional therapies while wearing wireless sensors (triaxial accelerometers) at both ankles. Activity-recognition algorithms calculated the speed, distance, and duration of walking bouts. Three times a week, therapists provided either feedback about performance on a 10-meter walk (speed only) or walking speed feedback plus a review of walking activity recorded by the sensors (augmented). Primary outcomes at discharge included total daily walking time, derived from the sensors, and a timed 15-meter walk.Sixteen rehabilitation centers in 11 countries enrolled 135 participants over 15 months. Sensors recorded more than 1800 days of therapy, 37 000 individual walking bouts, and 2.5 million steps. No significant differences were found between the 2 feedback groups in daily walking time (15.1 ± 13.1 vs 16.6 ± 14.3 minutes, P = .54) or 15-meter walking speed (0.93 ± 0.47 vs 0.91 ± 0.53 m/s, P = .96). Remarkably, 30% of participants decreased their total daily walking time over their rehabilitation stay.In this first trial of remote monitoring of inpatient stroke rehabilitation, augmented feedback beyond speed alone did not increase the time spent practicing or improve walking outcomes. Remarkably modest time was spent walking. Wireless sensing, however, allowed clinicians to audit skills practice and provided ground truth regarding changes in clinically important, mobility-related activities.

SUBMITTER: Dorsch AK

PROVIDER: S-EPMC4375021 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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SIRRACT: An International Randomized Clinical Trial of Activity Feedback During Inpatient Stroke Rehabilitation Enabled by Wireless Sensing.

Dorsch Andrew K AK Thomas Seth S Xu Xiaoyu X Kaiser William W Dobkin Bruce H BH

Neurorehabilitation and neural repair 20140926 5

<h4>Background</h4>Walking-related disability is the most frequent reason for inpatient stroke rehabilitation. Task-related practice is a critical component for improving patient outcomes.<h4>Objective</h4>To test the feasibility of providing quantitative feedback about daily walking performance and motivating greater skills practice via remote sensing.<h4>Methods</h4>In this phase III randomized, single blind clinical trial, patients participated in conventional therapies while wearing wireless ...[more]

PMID: 25261154

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Project description:BACKGROUND:Practicing activities improves recovery after stroke, but many people in hospital do little activity. Feedback on activity using an accelerometer is a potential method to increase activity in hospital inpatients. This study's goal is to investigate the effect of feedback, enabled by a Smart watch, on daily physical activity levels during inpatient stroke rehabilitation and the short-term effects on simple functional activities, primarily mobility. METHODS/DESIGN:A randomized controlled trial will be undertaken within the stroke rehabilitation wards of the Second Affiliated hospital of Anhui University of Traditional Chinese Medicine, Hefei, China. The study participants will be stroke survivors who meet inclusion criteria for the study, primarily: able to participate, no more than 4 months after stroke and walking independently before stroke. Participants will all receive standard local rehabilitation and will be randomly assigned either to receive regular feedback about activity levels, relative to a daily goal tailored by the smart watch over five time periods throughout a working day, or to no feedback, but still wearing the Smart watch. The intervention will last up to 3 weeks, ending sooner if discharged. The data to be collected in all participants include measures of daily activity (Smart watch measure); mobility (Rivermead Mobility Index and 10-metre walking time); independence in personal care (Barthel Activities of Daily Living (ADL) Index); overall activities (the World Health Organization (WHO) Disability Assessment Scale, 12-item version); and quality of life (the Euro-Qol 5L5D). Data will be collected by assessors blinded to allocation of the intervention at baseline, 3 weeks or at discharge (whichever is the sooner); and a reduced data set will be collected at 12 weeks by telephone interview. The primary outcome will be change in daily accelerometer activity scores. Secondary outcomes are compliance and adherence to wearing the watch, and changes in mobility, independence in personal care activities, and health-related quality of life. DISCUSSION:This project is being implemented in a large city hospital with limited resources and limited research experience. There has been a pilot feasibility study using the Smart watch, which highlighted some areas needing change and these are incorporated in this protocol. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02587585 . Registered on 30 September 2015. Chinese Clinical Trial Registry, ChiCTR-IOR-15007179 . Registered on 8 August 2015.

Project description:Objective: It was the aim to assess feasibility, safety, and potential efficacy of a new intensive, focused arm-hand BOOST program and to investigate whether there is a difference between early vs. late delivery of the program in the sub-acute phase post stroke. Methods: In this pilot RCT, patients with stroke were randomized to the immediate group (IG): 4 weeks (4 w) BOOST +4 w CONTROL or the delayed group (DG): 4 w CONTROL +4 w BOOST, on top of their usual inpatient care program. The focused arm-hand BOOST program (1 h/day, 5x/week, 4 weeks) consisted of group exercises with focus on scapula-setting, core-stability, manipulation and complex ADL tasks. Additionally, 1 h per week the Armeo®Power (Hocoma AG, Switzerland) was used. The CONTROL intervention comprised a dose-matched program (24 one-hour sessions in 4 w) of lower limb strengthening exercises and general reconditioning. At baseline, after 4 and 8 weeks of training, the Fugl-Meyer assessment upper extremity (FMA-UE), action research arm test (ARAT), and stroke upper limb capacity scale (SULCS) were administered. Results: Eighteen participants (IG: n = 10, DG: n = 8) were included, with a median (IQR) time post stroke of 8.6 weeks (5-12). No adverse events were experienced. After 4 weeks of training, significant between-group differences were found for FMA-UE (p = 0.003) and SULCS (p = 0.033) and a trend for ARAT (p = 0.075) with median (IQR) change scores for the IG of 9 (7-16), 2 (1-3), and 12.5 (1-18), respectively, and for the DG of 0.5 (-3 to 3), 1 (0-1), and 1.5 (-1 to 9), respectively. In the IG, 80% of patients improved beyond the minimal clinical important difference of FMA-UE after 4 weeks, compared to none of the DG patients. Between 4 and 8 weeks of training, patients in the DG tend to show larger improvements when compared to the IG, however, between-group comparisons did not reach significance. Conclusions: Results of this pilot RCT showed that an intensive, specific arm-hand BOOST program, on top of usual care, is feasible and safe in the sub-acute phase post stroke and suggests positive, clinical meaningful effects on upper limb function, especially when delivered in the early sub-acute phase post stroke. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04584177.

Project description:BackgroundAs many as 80% of stroke survivors experience upper limb (UL) disability. The strong relationships between disability, lost productivity, and ongoing health care costs mean reducing disability after stroke is critical at both individual and society levels. Unfortunately, the amount of UL-focused rehabilitation received by people with stroke is extremely low. Activity monitoring and promotion using wearable devices offer a potential technology-based solution to address this gap. Commonly, wearable devices are used to deliver a haptic nudge to the wearer with the aim of promoting a particular behavior. However, little is known about the effectiveness of haptic nudging in promoting behaviors in patient populations.ObjectiveThis study aimed to estimate the effect of haptic nudging delivered via a wrist-worn wearable device on UL movement in people with UL disability following stroke undertaking inpatient rehabilitation.MethodsA multiple-period randomized crossover design was used to measure the association of UL movement with the occurrence of haptic nudge reminders to move the affected UL in 20 people with stroke undertaking inpatient rehabilitation. UL movement was observed and classified using movement taxonomy across 72 one-minute observation periods from 7:00 AM to 7:00 PM on a single weekday. On 36 occasions, a haptic nudge to move the affected UL was provided just before the observation period. On the other 36 occasions, no haptic nudge was given. The timing of the haptic nudge was randomized across the observation period for each participant. Statistical analysis was performed using mixed logistic regression. The effect of a haptic nudge was evaluated from the intention-to-treat dataset as the ratio of the odds of affected UL movement during the observation period following a "Planned Nudge" to the odds of affected limb movement during the observation period following "No Nudge."ResultsThe primary intention-to-treat analysis showed the odds ratio (OR) of affected UL movement following a haptic nudge was 1.44 (95% CI 1.28-1.63, P<.001). The secondary analysis revealed an increased odds of affected UL movement following a Planned Nudge was predominantly due to increased odds of spontaneous affected UL movement (OR 2.03, 95% CI 1.65-2.51, P<.001) rather than affected UL movement in conjunction with unaffected UL movement (OR 1.13, 95% CI 0.99-1.29, P=.07).ConclusionsHaptic nudging delivered via a wrist-worn wearable device increases affected UL movement in people with UL disability following stroke undertaking inpatient rehabilitation. The promoted movement appears to be specific to the instructions given.Trial registrationAustralia New Zealand Clinical Trials Registry 12616000654459; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370687&isReview=true.

Project description:Purpose: Robot-assisted training has been widely used in neurorehabilitation, but its effect on facilitating recovery after stroke remains controversial. One possible reason might be lacking consideration of the role of embodiment in robotic systems. Mirror visual feedback is an ideal method to approach embodiment. Thus, we hypothesized that mirror visual feedback priming with subsequent robot-assisted training might provide additional treatment benefits in rehabilitation. Method: This is a prospective, assessor-blinded, randomized, controlled study. Forty subacute stroke patients were randomly assigned into an experimental group (N = 20) or a control group (N = 20). They received either mirror visual feedback or sham-mirror visual feedback prior to robot-assisted training for 1.5 h/day, 5 days/week for 4 weeks. Before and after intervention, the Fugl-Meyer Assessment Upper Limb subscale, the Functional Independence Measure, the modified Barthel Index, and grip strength were measured. Scores of four specified games were recorded pre and post one-time mirror visual feedback priming before intervention in the experimental group. Results: All measurements improved significantly in both groups following interventions. Moreover, the Fugl-Meyer Assessment Upper Limb subscale, self-care subscale of the Functional Independence Measure, and the grip strength were improved significantly in the experimental group after a 4-week intervention, compared with the control group. Significantly higher scores of two games were revealed after one-time priming. Conclusions: Mirror visual feedback prior to robot-assisted training could prompt motor recovery, increase ability of self-care, and potentially enhance grip strength in stroke patients, compared to control treatment. Moreover, mirror visual feedback priming might have the capability to improve the patient's performance and engagement during robot-assisted training, which could prompt the design and development of robotic systems. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: ChiCTR1900023356.

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SIRRACT: An International Randomized Clinical Trial of Activity Feedback During Inpatient Stroke Rehabilitation Enabled by Wireless Sensing.

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SIRRACT: An International Randomized Clinical Trial of Activity Feedback During Inpatient Stroke Rehabilitation Enabled by Wireless Sensing.

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