Pilot comparative effectiveness study of surface perturbation treadmill training to prevent falls in older adults.
ABSTRACT: Falls are the leading cause of fatal and non-fatal injuries among older adults. Exercise programs appear to reduce fall risk, but the optimal type, frequency, and duration of exercise is unknown. External perturbations such as tripping and slipping are a major contributor to falls, and task-specific perturbation training to enhance dynamic stability has emerged as a promising approach to modifying fall risk. The purpose of this pilot study was 1) to determine the feasibility of conducting a large pragmatic randomized trial comparing a multidimensional exercise program inclusive of the surface perturbation treadmill training (SPTT) to multidimensional exercise alone (Standard PT); and 2) to assess fall outcomes between the two groups to determine whether an effect size large enough to warrant further study might be present.A randomized pilot study at two outpatient physical therapy clinics. Participants were over age 64 and referred for gait and balance training. Feasibility for a larger randomized trial was assessed based on the ability of therapists to incorporate the SPTT into their clinical practice and acceptance of study participation by eligible patients. Falls were assessed by telephone interview 3 months after enrollment.Of 83 patients who were screened, 73 met inclusion criteria. SPTT was successfully adapted into clinical practice and 88% of eligible subjects were willing to be randomized, although 10% of the SPTT cohort dropped out prior to treatment. The SPTT group showed fewer subjects having any fall (19.23% vs. 33.33% Standard PT; p < 0.227) and fewer having an injurious fall (7.69% vs. 18.18%; p < 0.243). These results were not statistically significant but this pilot study was not powered for hypothesis testing.Physical therapy inclusive of surface perturbation treadmill training appears clinically feasible, and randomization between these two PT interventions is acceptable to the majority of patients. These results appear to merit longer-term study in an adequately powered trial.clinicaltrials.gov: NCT01006967.
Project description:<h4>Background</h4>Falls are the leading cause of injuries among older adults, and trips and slips are major contributors to falls.<h4>Objective</h4>The authors sought to compare the effectiveness of adding a component of surface perturbation training to usual gait/balance training for reducing falls and fall-related injury in high-risk older adults referred to physical therapy.<h4>Design</h4>This was a multi-center, pragmatic, randomized, comparative effectiveness trial.<h4>Setting</h4>Treatment took place within 8 outpatient physical therapy clinics.<h4>Patients</h4>This study included 506 patients 65+ years of age at high fall risk referred for gait/balance training.<h4>Intervention</h4>This trial evaluated surface perturbation treadmill training integrated into usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone.<h4>Measurements</h4>Falls and injurious falls were assessed with a prospective daily fall diary, which was reviewed via telephone interview every 3 months for 1 year.A total of 211/253 (83%) patients randomized to perturbation training and 210/253 (83%) randomized to usual treatment provided data at 3-month follow-up. At 3 months, the perturbation training group had a significantly reduced chance of fall-related injury (5.7% versus 13.3%; relative risk 0.43) but no significant reduction in the risk of any fall (28% versus 37%, relative risk 0.78) compared with usual treatment. Time to first injurious fall showed reduced hazard in the first 3 months but no significant reduction when viewed over the entire first year.<h4>Limitations</h4>The limitations of this trial included lack of blinding and variable application of interventions across patients based on pragmatic study design.<h4>Conclusion</h4>The addition of some surface perturbation training to usual physical therapy significantly reduced injurious falls up to 3 months posttreatment. Further study is warranted to determine the optimal frequency, dose, progression, and duration of surface perturbation aimed at training postural responses for this population.
Project description:BACKGROUND:The European population is rapidly ageing. There is an urgent need for innovative solutions to reduce fall risk in older adults. Perturbation-based gait training is a promising new method to improve reactive balance responses. Whereas positive effects on task-specific dynamic balance recovery during gait have been shown in clinical or laboratory settings, translation of these effects to daily life gait function and fall risk is limited. We aim to evaluate the effect of a 4-week perturbation-based treadmill training on daily-life dynamic gait stability, assessed with inertial sensor data. Secondary outcomes are balance recovery performance, clinical balance and gait assessment scores, the amount of physical activity in daily life and falls incidence during 6?months follow-up. METHODS:The study is a monocenter assessor-blinded randomized controlled trial. The target study sample consists of 70 older adults of 65?years and older, living in the community and with an elevated risk of falling. A block-randomization to avoid seasonal effects will be used to allocate the participants into two groups. The experimental group receives a 4-week, two times per week perturbation-based gait training programme on a treadmill, with simulated slips and trips, in combination with cognitive dual tasks. The control group receives a 4-week, two times per week treadmill training programme under cognitive dual-task conditions without perturbations. Participants will be assessed at baseline and after the 4-weeks intervention period on their daily-life gait stability by wearing an inertial sensor on the lower back for seven consecutive days. In addition, clinical balance and gait assessments as well as questionnaires on falls- and gait-efficacy will be taken. Daily life falls will be followed up over 6 months by a fall calendar. DISCUSSION:Whereas perturbation-based training has shown positive effects in improving balance recovery strategies and in reducing laboratory falls, this study will contribute to investigate the translation of perturbation-based treadmill training effects in a clinical setting towards improving daily life gait stability and reducing fall risk and falls. TRIAL REGISTRATION:NTR7703 / NL66322.028.18, Registered: January 8, 2019; Enrolment of the first participant April 8, 2019.
Project description:Recent work has demonstrated that fall risk can be attributed to cognitive as well as motor deficits. Indeed, everyday walking in complex environments utilizes executive function, dual tasking, planning and scanning, all while walking forward. Pilot studies suggest that a multi-modal intervention that combines treadmill training to target motor function and a virtual reality obstacle course to address the cognitive components of fall risk may be used to successfully address the motor-cognitive interactions that are fundamental for fall risk reduction. The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.Three hundred older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (n=100), and patients with Parkinson's disease (n=100). These three sub-groups will be recruited in order to evaluate the effects of the intervention in people with a range of motor and cognitive deficits. Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training. A falls calendar will be kept by each participant for 6 months after completing the training to assess fall incidence (i.e., the number of falls, multiple falls and falls rate). In addition, we will measure gait under usual and dual task conditions, balance, community mobility, health related quality of life, user satisfaction and cognitive function.This randomized controlled trial will demonstrate the extent to which an intervention that combines treadmill training augmented by virtual reality reduces fall risk, improves mobility and enhances cognitive function in a diverse group of older adults. In addition, the comparison to an active control group that undergoes treadmill training without virtual reality will provide evidence as to the added value of addressing motor cognitive interactions as an integrated unit.(NIH)-NCT01732653.
Project description:BACKGROUND:Exercise has failed to reduce falls in those with chronic stroke. A limitation of traditional exercise is that the motor responses needed to prevent a fall are not elicited (i.e. they lack processing specificity). Balance reactions often require compensatory steps. Therefore, interventions that target such steps have the potential to reduce falls. Computerized treadmills can deliver precise, repeatable, and challenging perturbations as part of a training protocol. The objective of this study was to develop and determine the feasibility of such training applied to those with chronic stroke. We developed the training to address specificity, appropriate duration and repetition, and progressive overloading and individualization. We hypothesized that our intervention would be acceptable, practical, safe, and demonstrate initial signs of efficacy. METHODS:In this single-arm study, thirteen individuals with chronic stroke (29-77?years old, 2-15?years post stroke) performed up to six training sessions using a computer-controlled treadmill. Each session had separate progressions focused on initial steps with the non-paretic or paretic limbs in response to anterior or posterior falls. Perturbation magnitudes were altered based on performance and tolerance. Acceptability was determined by adherence, or the number of sessions completed. Practicality was documented by the equipment, space, time, and personnel. Adverse events were documented to reflect safety. In order to determine the potential-efficacy of this training, we compared the proportion of successful recoveries and the highest perturbation magnitude achieved on the first and last sessions. RESULTS:The training was acceptable, as evident by 12/13 participants completing all 6 sessions. The protocol was practical, requiring one administrator, the treadmill, and a harness. The protocol was safe, as evident by no serious or unanticipated adverse events. The protocol demonstrated promising signs of efficacy. From the first to last sessions, participants had a higher proportion of successful recoveries and progressed to larger disturbances. CONCLUSIONS:Using a computerized treadmill, we developed an approach to fall-recovery training in individuals with chronic stroke that was specific, considered duration and repetition, and incorporated progressive overloading and individualization. We demonstrated that this training was acceptable, practical, safe, and potentially beneficial for high-functioning individuals with chronic stroke. TRIAL REGISTRATION:Retrospectively registered at clinicaltrials.gov ( NCT03638089 ) August 20, 2018.
Project description:<h4>Background</h4>Balance control, and specifically balance reactive responses that contribute to maintaining balance when balance is lost unexpectedly, is impaired in older people. This leads to an increased fall risk and injurious falls. Improving balance reactive responses is one of the goals in fall-prevention training programs. Perturbation training during standing or treadmill walking that specifically challenges the balance reactive responses has shown very promising results; however, only older people who are able to perform treadmill walking can participate in these training regimes. Thus, we aimed to develop, build, and pilot a mechatronic Perturbation Stationary Bicycle Robotic system (i.e., PerStBiRo) that can challenge balance while sitting on a stationary bicycle, with the aim of improving balance proactive and reactive control.<h4>Methods</h4>This paper describes the development, and building of the PerStBiRo using stationary bicycles. In addition, we conducted a pilot randomized control trial (RCT) with 13 older people who were allocated to PerStBiRo training (N?=?7) versus a control group, riding stationary bicycles (N?=?6). The Postural Sway Test, Berg Balance Test (BBS), and 6-min Walk Test were measured before and after 3 months i.e., 20 training sessions.<h4>Results</h4>The PerStBiRo System provides programmed controlled unannounced lateral balance perturbations during stationary bicycling. Its software is able to identify a trainee's proactive and reactive balance responses using the Microsoft Kinect™ system. After a perturbation, when identifying a trainee's trunk and arm reactive balance response, the software controls the motor of the PerStBiRo system to stop the perturbation. The pilot RCT shows that, older people who participated in the PerStBiRo training significantly improved the BBS (54 to 56, p?=?0.026) and Postural Sway velocity (20.3?m/s to 18.3?m/s, p?=?0.018), while control group subject did not (51.0 vs. 50.5, p?=?0.581 and 15?m/s vs. 13.8?m/s, p?=?0.893, respectively), 6MWT tended to improve in both groups.<h4>Conclusions</h4>Our participants were able to perform correct balance proactive and reactive responses, indicating that older people are able to learn balance trunk and arm reactive responses during stationary bicycling. The pilot study shows that these improvements in balance proactive and reactive responses are generalized to performance-based measures of balance (BBS and Postural Sway measures).
Project description:BACKGROUND:The presence of mild cognitive impairment (MCI) in older adults increases their fall risk. While physical exercise is effective in reducing falls rate and risk of falls, and cognitive training in improving cognitive functioning in healthy older adults, their effectiveness in preventing falls and reducing risks of falls in MCI when administered simultaneously is not yet established. Therefore, this study aims to determine the effectiveness of combined physical and cognitive training in preventing falls and decreasing risks of falls among community-dwelling older persons with MCI. METHODS/DESIGN:This is a single-blind, multicentre, randomized controlled trial. At least ninety-three community-dwelling older adults with MCI aged 60 or above will be recruited. They will be randomly allocated into four groups: Physical Training alone (PT), Cognitive Training alone (CT), combined Physical And Cognitive Training (PACT) and Waitlist Group (WG). The PT group will perform exercises (flexibility, endurance, strengthening, and balance training) for 60-90 min three times per week for 12 weeks. The CT group will be involved in a paper-based training focusing on orientation, memory, attention and executive functioning for 60-90 min per session, once a week for 12 weeks. The PACT group will undergo cognitive training incorporated in physical exercise for 60-90 min three times per week for 12 weeks. The WG will receive the intervention, combined physical and cognitive training, at a later date. Assessors blinded to participant allocation will conduct pre-intervention, post-intervention, and 6-month follow-up assessments. The primary outcome measure will be falls rate. The secondary outcome measures will be Physiologic Profile Assessment and Falls Risk for Older Persons in the Community, and assessments that evaluate cognitive, physical and psychological factors related to falls. DISCUSSION:Considering the possible physical, social, financial and psychological consequences of a fall, we hope to provide insights on the effectiveness of combining physical and cognitive training on falls and fall-related factors for older adults with MCI. It is projected that the combined interventions will lead to significantly lower falls rate and reduced risk of falls compared to using single or no intervention. TRIAL REGISTRATION:ClinicalTrials.gov NCT03167840 . Registered on May 30, 2017.
Project description:The purpose of this study was to determine any potential falls-resistance benefits that might arise from treadmill-slip-perturbation training. One hundred sixty-six healthy community-dwelling older adults were randomly assigned to either the treadmill-slip-training group (Tt) or the treadmill-control group (Tc). Tt received 40 slip-like perturbations during treadmill walking. Tc received unperturbed treadmill walking for 30?min. Following their treadmill session, both groups were exposed to a novel slip during over-ground walking. Their responses to this novel slip were also compared to previously collected data from participants who received either over-ground-slip training (Ot) with 24 slips or over-ground walking (Oc) with no training before experiencing their novel over-ground slip. Fall rates and both proactive (pre-slip) and reactive (post-slip) stability were assessed and compared for the novel over-ground slip in groups Tt, Tc, and Oc, as well as for the 24th slip in Ot. Results showed Tt had fewer falls than Tc (9.6% versus 43.8%, p?<?0.001) but more falls than Ot (9.6% versus 0%, p?<?0.001). Tt also had greater proactive and reactive stability than Tc (Tt?>?Tc, p?<?0.01), however, Tt's stabilities were lower than those of Ot (p?<?0.01). There was no difference in fall-rate or reactive stability between Tc and Oc, though treadmill walking did improve the proactive stability control of the latter. While the treadmill-slip-training protocol could immediately reduce the numbers of falls from a novel laboratory-reproduced slip, such improvements were far less than that from the motor adaptation to the over-ground-slip-training protocol.
Project description:Falls are a leading cause of injury, hospitalization and even death among older adults. Although various strength and balance exercise interventions have shown moderate reductions in falls incidence among healthy older adults, no significant falls incidence improvements have been consistently seen in frail older adults or in patient groups with an increased falls risk (e.g. people with Parkinson's disease and stroke). This might be due to a lack of task specificity of previous exercise interventions to the recovery actions required to prevent a fall. Perturbation-based balance training (PBT) is an emerging task-specific intervention that aims to improve reactive balance control after destabilizing perturbations in a safe and controlled environment. Although early studies were carried out predominantly in research laboratory settings, work in clinical settings with various patient groups has been proliferating. A systematic search of recent PBT studies showed a significant reduction of falls incidence among healthy older adults and certain patient groups (e.g. people with Parkinson's disease and stroke), with clinically relevant reductions in frail older adults. The most practical methods in clinical settings might be treadmill-based systems and therapist-applied perturbations, and PBT that incorporates multiple perturbation types and directions might be of most benefit. Although more controlled studies with long-term follow-up periods are required to better elucidate the effects of PBT on falls incidence, PBT appears to be a feasible and effective approach to falls reduction among older adults in clinical settings. Geriatr Gerontol Int 2017; 17: 2294-2303..
Project description:<h4>Background</h4>Walking requires gait adjustments in order to walk safely in continually changing environments. Gait adaptability is reduced in older adults, and (near) falls, fall-related hip fractures and fear of falling are common in this population. Most falls occur due to inaccurate foot placement relative to environmental hazards, such as obstacles. The C-Mill is an innovative, instrumented treadmill on which visual context (e.g., obstacles) is projected. The C-Mill is well suited to train foot positioning relative to environmental properties while concurrently utilizing the high-intensity practice benefits associated with conventional treadmill training. The present protocol was designed to examine the efficacy of C-Mill gait adaptability treadmill training for improving walking ability and reducing fall incidence and fear of falling relative to conventional treadmill training and usual care. We hypothesize that C-Mill gait adaptability treadmill training and conventional treadmill training result in better walking ability than usual care due to the enhanced training intensity, with superior effects for C-Mill gait adaptability treadmill training on gait adaptability aspects of walking given the concurrent focus on practicing step adjustments.<h4>Methods/design</h4>The protocol describes a parallel group, single-blind, superiority randomized controlled trial with pre-tests, post-tests, retention-tests and follow-up. Hundred-twenty-six older adults with a recent fall-related hip fracture will be recruited from inpatient rehabilitation care and allocated to six weeks of C-Mill gait adaptability treadmill training (high-intensity, adaptive stepping), conventional treadmill training (high-intensity, repetitive stepping) or usual care physical therapy using block randomization, with allocation concealment by opaque sequentially numbered envelopes. Only data collectors are blind to group allocation. Study parameters related to walking ability will be assessed as primary outcome pre-training, post-training, after 4 weeks retention and 12 months follow-up. Secondary study parameters are measures related to fall incidence, fear of falling and general health.<h4>Discussion</h4>The study will shed light on the relative importance of adaptive versus repetitive stepping and practice intensity for effective intervention programs directed at improving walking ability and reducing fall risk and fear of falling in older adults with a recent fall-related hip fracture, which may help reduce future fall-related health-care costs.
Project description:BACKGROUND:Physical activity is linked to many positive health outcomes, stimulating the development of exercise programs. However, many falls occur while walking and so promoting activity might paradoxically increase fall rates, causing injuries, and worse quality of life. The relationship between activity exposure and fall rates remains unclear. We investigated the relationship between walking activity (exposure to risk) and fall rates before and after an exercise program (V-TIME). METHODS:One hundred and nine older fallers, 38 fallers with mild cognitive impairment (MCI), and 128 fallers with Parkinson's disease (PD) were randomly assigned to one of two active interventions: treadmill training only or treadmill training combined with a virtual reality component. Participants were tested before and after the interventions. Free-living walking activity was characterized by volume, pattern, and variability of ambulatory bouts using an accelerometer positioned on the lower back for 1 week. To evaluate that relationship between fall risk and activity, a normalized index was determined expressing fall rates relative to activity exposure (FRA index), with higher scores indicating a higher risk of falls per steps taken. RESULTS:At baseline, the FRA index was higher for fallers with PD compared to those with MCI and older fallers. Walking activity did not change after the intervention for the groups but the FRA index decreased significantly for all groups (p???.035). CONCLUSIONS:This work showed that V-TIME interventions reduced falls risk without concurrent change in walking activity. We recommend using the FRA index in future fall prevention studies to better understand the nature of intervention programs.