scholarly journals Real-Time Foot Clearance Biofeedback to Assist Gait Rehabilitation Following Stroke: a Randomised Controlled Trial Protocol

2019 ◽  
Author(s):  
REZAUL BEGG ◽  
Mary Galea ◽  
Lisa James ◽  
Tony Sparrow ◽  
Pazit Levinger ◽  
...  

Abstract Background The risk of falling is significantly higher in people with chronic stroke and it is, therefore, important to design interventions to improve mobility and decrease falls risk. Minimum Toe Clearance (MTC) is the key gait cycle event for predicting tripping-falls because it occurs mid-swing during the walking cycle where forward velocity of the foot is maximum. High forward velocity coupled with low MTC increases the probability of unanticipated foot-ground contacts. Training procedures to increase toe-ground clearance (MTC) have potential, therefore, as a falls prevention intervention. The aim of this project is to determine whether augmented sensory information via real-time visual biofeedback during gait training can increase MTC. Methods Participants will be over 18 years, have sustained a single stroke (ischaemic or hemorrhagic) at least 6 months previously, able to walk 50 metres independently and capable of informed consent. Using a secure web-based application (REDCap) 150 participants will be randomly assigned to either no-feedback (Control) or feedback (Experimental) groups, all will receive 10 sessions of treadmill training for up to 10 minutes at a self-selected speed over five to six weeks. The intervention group will receive real-time, visual biofeedback of MTC during training and will be asked to modify their gait pattern to match a required “target” criterion. Biofeedback is continuous for the first six sessions then progressively reduced (faded) across the remaining four sessions. Control participants will walk on the treadmill without biofeedback. Gait assessments are conducted at baseline, immediately following the final training session and then during follow-up, at 1, 3 and 6 months. The primary outcome measure is MTC. Monthly falls calendars will also be collected for 12 months from enrolment. Discussion The project will contribute to understanding how stroke-related changes to sensory and motor processes influence gait biomechanics and associated tripping risk. The research findings will guide our work in gait rehabilitation following stroke and may reduce falls rates. Treadmill training procedures incorporating continuous real-time feedback may need to be modified to accommodate stroke patients who have greater difficulties with treadmill walking.

2018 ◽  
Author(s):  
Rezaul Begg ◽  
Mary Galea ◽  
Lisa James ◽  
Tony Sparrow ◽  
Pazit Levinger ◽  
...  

Abstract Background: The risk of falling is significantly higher in people with chronic stroke and it is, therefore, important to design interventions to improve mobility and decrease falls risk. Minimum Toe Clearance (MTC) is the key gait cycle event for predicting tripping-falls because it occurs mid-swing during the walking cycle where forward velocity of the foot is maximum. High forward velocity coupled with low MTC increases the probability of unanticipated foot-ground contacts. Training procedures to increase toe-ground clearance (MTC) have potential, therefore, as a falls prevention intervention. The aim of this project is to determine whether augmented sensory information via real-time visual biofeedback during gait training can increase MTC. Methods: Participants will be over 18 years, have sustained a single stroke (ischaemic or hemorrhagic) at least 6 months previously, able to walk 50 metres independently and capable of informed consent. Using a secure web-based application (REDCap) 150 participants will be randomly assigned to either no-feedback (Control) or feedback (Experimental) groups, all will receive 10 sessions of treadmill training for up to 10 minutes at a self-selected speed over five to six weeks. The intervention group will receive real-time, visual biofeedback of MTC during training and will be asked to modify their gait pattern to match a required “target” criterion. Biofeedback is continuous for the first six sessions then progressively reduced (faded) across the remaining four sessions. Control participants will walk on the treadmill without biofeedback. Gait assessments are conducted at baseline, immediately following the final training session and then during follow-up, at 1, 3 and 6 months. The primary outcome measure is MTC. Monthly falls calendars will also be collected for 12 months from enrolment. Discussion: This project will evaluate the impact of augmented sensory information, via visually presented biofeedback, for improving gait function in people with stroke. This has implications for the rehabilitation of gait disorders following stroke and may have the potential to reduce falls in this population.


2017 ◽  
Vol 21 (24) ◽  
pp. 1-198 ◽  
Author(s):  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Lorraine Green ◽  
Caroline Fairhurst ◽  
Joy Adamson ◽  
...  

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Rebecca L. Morris ◽  
Keith D. Hill ◽  
Ilana N. Ackerman ◽  
Darshini Ayton ◽  
Glenn Arendts ◽  
...  

Abstract Background RESPOND is a telephone-based falls prevention program for older people who present to a hospital emergency department (ED) with a fall. A randomised controlled trial (RCT) found RESPOND to be effective at reducing the rate of falls and fractures, compared with usual care, but not fall injuries or hospitalisations. This process evaluation aimed to determine whether RESPOND was implemented as planned, and identify implementation barriers and facilitators. Methods A mixed-methods evaluation was conducted alongside the RCT. Evaluation participants were the RESPOND intervention group (n = 263) and the clinicians delivering RESPOND (n = 7). Evaluation data were collected from participant recruitment and intervention records, hospital administrative records, audio-recordings of intervention sessions, and participant questionnaires. The Rochester Participatory Decision-Making Scale (RPAD) was used to evaluate person-centredness (score range 0 (worst) - 9 (best)). Process factors were compared with pre-specified criteria to determine implementation fidelity. Six focus groups were held with participants (n = 41), and interviews were conducted with RESPOND clinicians (n = 6). Quantitative data were analysed descriptively and qualitative data thematically. Barriers and facilitators to implementation were mapped to the ‘Capability, Opportunity, Motivation – Behaviour’ (COM-B) behaviour change framework. Results RESPOND was implemented at a lower dose than the planned 10 h over 6 months, with a median (IQR) of 2.9 h (2.1, 4). The majority (76%) of participants received their first intervention session within 1 month of hospital discharge with a median (IQR) of 18 (12, 30) days. Clinicians delivered the program in a person-centred manner with a median (IQR) RPAD score of 7 (6.5, 7.5) and 87% of questionnaire respondents were satisfied with the program. The reports from participants and clinicians suggested that implementation was facilitated by the use of positive and personally relevant health messages. Complex health and social issues were the main barriers to implementation. Conclusions RESPOND was person-centred and reduced falls and fractures at a substantially lower dose, using fewer resources, than anticipated. However, the low dose delivered may account for the lack of effect on falls injuries and hospitalisations. The results from this evaluation provide detailed information to guide future implementation of RESPOND or similar programs. Trial registration This study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12614000336684 (27 March 2014).


Neurology ◽  
2018 ◽  
Vol 91 (14) ◽  
pp. e1319-e1327 ◽  
Author(s):  
Jeannine Bergmann ◽  
Carmen Krewer ◽  
Klaus Jahn ◽  
Friedemann Müller

ObjectiveTo determine the effects of 2 weeks of intensive robot-assisted gait training (RAGT) on pusher behavior compared to nonrobotic physiotherapy (nR-PT).MethodsIn a single-blind, randomized, controlled trial with 2 parallel arms, we compared 2 weeks of daily RAGT (intervention group) with the same amount of nR-PT (control group). Patients with subacute stroke who had pusher behavior according to the Scale for Contraversive Pushing (SCP) were included. The primary research questions were whether changes in pusher behavior would differ between groups post intervention, and at a follow-up 2 weeks afterward (SCP and Burke Lateropulsion Scale, Class II evidence). Secondary outcomes included the Performance-Oriented Mobility Assessment, the Functional Ambulation Classification, and the Subjective Visual Vertical.ResultsThirty-eight patients were randomized. Thereof, 30 patients received the allocated intervention and were included in the analyses. RAGT led to a larger reduction of pusher behavior than nR-PT at post test (SCP: U = 69.00, r = −0.33, p = 0.037; Burke Lateropulsion Scale: U = 47.500, r = −0.50, p = 0.003) and at follow-up (SCP: U = 54.00, r = −0.44, p = 0.008). Pusher behavior had ceased in 6 of 15 participants in the intervention group and 1 of 15 participants in the control group at post test. At follow-up, 9 of 15 and 5 of 15 participants, respectively, no longer exhibited the behavior.ConclusionsTwo weeks of RAGT seems to persistently reduce pusher behavior, possibly by recalibrating the disturbed inner reference of verticality. The potential benefits of RAGT on pusher behavior and verticality perception require further investigation.Trial registrationGerman Clinical Trials Register (registration number: DRKS00003444).Classification of evidenceThis study provides Class II evidence that RAGT is beneficial to reduce pusher behavior in patients with stroke.


2020 ◽  
Vol 10 (12) ◽  
pp. 978
Author(s):  
Hanatsu Nagano ◽  
Catherine M. Said ◽  
Lisa James ◽  
Rezaul K. Begg

Hemiplegic stroke often impairs gait and increases falls risk during rehabilitation. Tripping is the leading cause of falls, but the risk can be reduced by increasing vertical swing foot clearance, particularly at the mid-swing phase event, minimum foot clearance (MFC). Based on previous reports, real-time biofeedback training may increase MFC. Six post-stroke individuals undertook eight biofeedback training sessions over a month, in which an infrared marker attached to the front part of the shoe was tracked in real-time, showing vertical swing foot motion on a monitor installed in front of the subject during treadmill walking. A target increased MFC range was determined, and participants were instructed to control their MFC within the safe range. Gait assessment was conducted three times: Baseline, Post-training and one month from the final biofeedback training session. In addition to MFC, step length, step width, double support time and foot contact angle were measured. After biofeedback training, increased MFC with a trend of reduced step-to-step variability was observed. Correlation analysis revealed that MFC height of the unaffected limb had interlinks with step length and ankle angle. In contrast, for the affected limb, step width variability and MFC height were positively correlated. The current pilot-study suggested that biofeedback gait training may reduce tripping falls for post-stroke individuals.


Work ◽  
2021 ◽  
pp. 1-10
Author(s):  
Jenny Hultqvist ◽  
Pernilla Bjerkeli ◽  
Gunnel Hensing ◽  
Kristina Holmgren

BACKGROUND: Work-related stress (WRS) presents a risk for sick leave. However, effective methods to identify people at risk for sick leave due to WRS at an early stage are lacking in primary health care. OBJECTIVE: To evaluate whether a systematic early identification of WRS can prevent sick leave over 24 months after the intervention. METHODS: Study participants (n = 132 intervention; n = 139 control) were employed, non-sick-listed persons seeking care at primary health care centres. The intervention included early identification of WRS by a validated instrument, general practitioner (GP) awareness supported by a brief training session, patients’ self-reflection by instrument completion, GP giving the patient feedback at consultation and GP identifying preventive measures. The control group received treatment as usual. Outcome data were retrieved from the Swedish Social Insurance Agency. RESULTS: The intervention group had less registered median sick leave days (n = 56) than the control group (n = 65) but the difference was not statistically significant. CONCLUSIONS: The brief intervention was not proven effective in preventing sick leave in the following 24 months compared to treatment as usual. Further research on how to identify, advice and treat those at high risk for sick leave in primary health care is needed.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Rezaul Begg ◽  
Mary P. Galea ◽  
Lisa James ◽  
W. A. Tony Sparrow ◽  
Pazit Levinger ◽  
...  

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