An initial evaluation of the safety of a disposable oscillating positive expiratory pressure device in patients with chronic obstructive pulmonary disease: a sort-term pilot study.

BACKGROUND: Handheld oscillating positive expiratory pressure (OPEP) devices have been a mainstay of treatment for patients with hypersecretory conditions such as cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) since the 1970s. Current devices are reusable and require regular cleaning and disinfection to prevent harbouring potentially pathogenic organisms. Adherence to cleaning regimens for respiratory devices is often poor and in response to this, a prototype disposable OPEP device-the 'UL-OPEP' (University of Limerick-Oscillating Positive Expiratory Pressure device)-was developed to mitigate the risk of contamination by pathogens. The device was previously evaluated successfully in a group of paediatric CF patients. The aim of the current study was to initially evaluate the safety of the prototype in patients with COPD over a period of 1 month to ensure no adverse events, negative impacts on lung function, exercise tolerance, or quality of life. Data on user experience of the device were also collected during post-study follow-up. METHODS: A sample of 50 volunteer participants were recruited from pulmonary rehabilitation clinics within the local hospital network. The patients were clinically stable, productive, and not current or previous users of OPEP devices. Participants were invited to use a prototype disposable OPEP device daily for a period of 1 month. Pre- and post-study lung function was assessed with standard spirometry, and exercise tolerance with the 6-min-walk-test (6MWT). Quality of life was assessed using the St. George's Respiratory Questionnaire (SGRQ), and user experience of the prototype device evaluated using a post-study questionnaire. RESULTS: 24 Participants completed the study: 9 were female. Overall median age was 67.5 years, range 53-85 years. Lung function, 6-min walk test, and SGRQ scores showed no significant change post-study. User feedback was positive overall. CONCLUSIONS: The results indicate that the UL-OPEP is safe to use in patients with COPD. No adverse events were recorded during the study or in the follow-up period of 2 weeks. The device did not negatively impact patients' lung function, exercise tolerance, or quality of life during short term use (1 month), and usability feedback received was generally positive. Larger, longer duration studies will be required to evaluate efficacy. Registration The study was approved as a Clinical Investigation by the Irish Health Products Regulatory Authority (CRN-2209025-CI0085).

A short-term evaluation of a prototype disposable Oscillating Positive Expiratory Pressure (OPEP) device in a cohort of children with cystic fibrosis.

BACKGROUND: Oscillating Positive Expiratory Pressure (OPEP) devices are important adjuncts to airway clearance therapy in patients with cystic fibrosis (CF). Current devices are typically reusable and require daily, or often more frequent, cleaning to prevent risk of infection by acting as reservoirs of potentially pathogenic organisms. In response, a daily disposable OPEP device, the UL-OPEP, was developed to mitigate the risk of contamination and eliminate the burdensome need for cleaning devices. METHODS: A convenience sample of 36 participants, all current OPEP device users, was recruited from a paediatric CF service. For one month, participants replaced their current OPEP device with a novel daily disposable device. Assessment included pre- and post-intervention lung function by spirometry, as well as Lung Clearance Index. Quality of life was assessed using the Cystic Fibrosis Questionnaire - Revised, while user experience was evaluated with a post-study survey. RESULTS: 31 participants completed the study: 18 males; median age 10 years, range 4-16 years. Lung function (mean difference ± SD, %FEV1 = 1.69 ± 11.93; %FVC = 0.58 ± 10.04; FEV1: FVC = 0.01 ± 0.09), LCI (mean difference ± SD, 0.08 ± 1.13), six-minute walk test, and CFQ-R were unchanged post-intervention. Participant-reported experiences of the device were predominantly positive. CONCLUSIONS: The disposable OPEP device maintained patients' lung function during short term use (≤ 1 month), and was the subject of positive feedback regarding functionality while reducing the risk of airway contamination associated with ineffective cleaning. REGISTRATION: The study was approved as a Clinical Investigation by the Irish Health Products Regulatory Authority (CRN-2209025-CI0085).

Kinematic and kinetic functional requirements for industrial exoskeletons for lifting tasks and overhead lifting.

The aim of this study was to sample human kinematics and kinetics during simulated tasks to aid the design of industrial exoskeletons. Twelve participants performed two dynamic tasks; a simulated lifting task and an overhead lifting task. Based on the current data, to completely assist a worker with lifting loads up to 15 kg, hip actuators would need to supply up to 111 Nm of extensor torque at speeds up to 139°/s of extension velocity and 26°/s of flexion velocity. The actuators should allow the hip to extend to 11° and flex to 95°, and supply a power of 212 W. To completely assist workers lifting a 3 kg load overhead, actuators assisting shoulder flexion would need to supply up to 20 Nm of flexor torque at speeds up to 21°/s of extension velocity and 116°/s of flexion velocity. The actuators should also allow 67° of shoulder flexion and supply a power of 27 W. Practitioner summary: There is increasing interest in developing exoskeletons for industrial applications. This study details relevant kinetic and kinematic exposures for common production tasks, which can be used to inform functional requirements of industrial exoskeletons.AbbreviationsWMSD(s)work-related musculoskeletal disordersMMHmanual materials handlingDOFdegrees of freedomBLEEXBerkeley lower extremity exoskeletonLED(s)light emitting diodeRelrelativeHighlightsThis study sampled joint kinematic and kinetic activity to inform design of industrial exoskeletons.The study presents sample values to two types of common industrial tasks across the major joints as are often assisted.We also indicate considerations on which joints should be considered to be actively assisted.

Exoscore: A Design Tool to Evaluate Factors Associated With Technology Acceptance of Soft Lower Limb Exosuits by Older Adults.

OBJECTIVE: This pilot study proposed and performs initial testing with Exoscore, a design evaluation tool to assess factors related to acceptance of exoskeleton by older adults, during the technology development and testing phases. BACKGROUND: As longevity increases and our aging population continues to grow, assistive technologies such as exosuits and exoskeletons can provide enhanced quality of life and independence. Exoscore is a design and prototype stage evaluation method to assess factors related to perceptions of the technology, the aim being to optimize technology acceptance. METHOD: In this pilot study, we applied the three-phase Exoscore tool during testing with 11 older adults. The aims were to explore the feasibility and face validity of applying the design evaluation tool during user testing of a prototype soft lower limb exoskeleton. RESULTS: The Exoscore method is presented as part of an iterative design evaluation process. The method was applied during an exoskeleton research and development project. The data revealed the aspects of the concept design that rated favorably with the users and the aspects of the design that required more attention to improve their potential acceptance when deployed as finished products. CONCLUSION: Exoscore was effectively applied to three phases of evaluation during a testing session of a soft exoskeleton. Future exoskeleton development can benefit from the application of this design evaluation tool. APPLICATION: This study reveals how the introduction of Exoscore to exoskeleton development will be advantageous when assessing technology acceptance of exoskeletons by older adults.

The effect of control strategies for an active back-support exoskeleton on spine loading and kinematics during lifting.

With mechanical loading as the main risk factor for LBP, exoskeletons (EXO) are designed to reduce the load on the back by taking over part of the moment normally generated by back muscles. The present study investigated the effect of an active exoskeleton, controlled using three different control modes (INCLINATION, EMG & HYBRID), on spinal compression forces during lifting with various techniques. Ten healthy male subjects lifted a 15 kg box, with three lifting techniques (free, squat & stoop), each of which was performed four times, once without EXO and once each with the three different control modes. Using inverse dynamics, we calculated L5/S1 joint moments. Subsequently, we estimated spine forces using an EMG-assisted trunk model. Peak compression forces substantially decreased by 17.8% when wearing the EXO compared to NO EXO. However, this reduction was partly, by about one third, attributable to a reduction of 25% in peak lifting speed when wearing the EXO. While subtle differences in back load patterns were seen between the three control modes, no differences in peak compression forces were found. In part, this may be related to limitations in the torque generating capacity of the EXO. Therefore, with the current limitations of the motors it was impossible to determine which of the control modes was best. Despite these limitations, the EXO still reduced both peak and cumulative compression forces by about 18%.

Cuff Pressure Algometry in Patients with Chronic Pain as Guidance for Circumferential Tissue Compression for Wearable Soft Exoskeletons: A Systematic Review.

In this article, we report on a systematic review of the literature on pressure-pain thresholds induced and assessed by computerized cuff pressure algometry (CPA). The motivation for this review is to provide design guidance on pressure levels for wearable soft exoskeletons and similar wearable robotics devices. In our review, we focus on CPA studies of patients who are candidates for wearable soft exoskeletons, as pain-related physiological mechanisms reportedly differ significantly between healthy subjects and patients with chronic pain. The results indicate that circumferential limb compression in patients most likely becomes painful at ∼10-18 kPa and can become unbearable even below 25 kPa. The corresponding ranges for healthy control subjects are 20-42 kPa (painful limits) and 34-84 kPa (unbearable levels). In addition, the increase of pain with time tends to be significantly higher, and the adaptation to pain significantly lower, than in healthy subjects. The results of this review provide guidance to designers of wearable robotics for populations with chronic pain regarding rates and magnitudes of tissue compression that may be unacceptable to users.

Elongation of the surface of the spine during lifting and lowering, and implications for design of an upper body industrial exoskeleton.

The aim of this study was to assess the elongation of the skin surface of the spine for simulated industrial lifting and lowering tasks to aid the design of industrial exoskeletons worn on the back. Eighteen male participants lifted and lowered a box of varying loads (5 kg, 10 kg, 15 kg) using three techniques (squat, semi-squat, stooped) from the ground to a table. Motion capture sensors attached to the spine from C7 to S1 measured movement. Stoop lifting involved significantly more elongation (mean 71.1 mm; margin of error ±6.9) than squat lifting (mean 36.8 mm; margin of error ±6.9). Load and Task (lift vs. lower) did not have a significant effect on elongation. Elongation of the skin surface of the lumbar spine was greater than for the thoracic spine. These data detail example levels of elongation of the skin surface of the spine, which should be considered in upper body wearable industrial exoskeleton design. Further, exoskeleton design should take into account that the skin surface of the lumbar spine involves greater elongation than the skin surface of the thoracic spine during deep lifting.

Computerized Cuff Pressure Algometry as Guidance for Circumferential Tissue Compression for Wearable Soft Robotic Applications: A Systematic Review.

In this article, we review the literature on quantitative sensory testing of deep somatic pain by means of computerized cuff pressure algometry (CPA) in search of pressure-related safety guidelines for wearable soft exoskeleton and robotics design. Most pressure-related safety thresholds to date are based on interface pressures and skin perfusion, although clinical research suggests the deep somatic tissues to be the most sensitive to excessive loading. With CPA, pain is induced in deeper layers of soft tissue at the limbs. The results indicate that circumferential compression leads to discomfort at ∼16-34 kPa, becomes painful at ∼20-27 kPa, and can become unbearable even below 40 kPa.

Rationale, Implementation and Evaluation of Assistive Strategies for an Active Back-Support Exoskeleton.

Active exoskeletons are potentially more effective and versatile than passive ones, but designing them poses a number of additional challenges. An important open challenge in the field is associated to the assistive strategy, by which the actuation forces are modulated to the user's needs during the physical activity. This paper addresses this challenge on an active exoskeleton prototype aimed at reducing compressive low-back loads, associated to risk of musculoskeletal injury during manual material handling (i.e., repeatedly lifting objects). An analysis of the biomechanics of the physical task reveals two key factors that determine low-back loads. For each factor, a suitable control strategy for the exoskeleton is implemented. The first strategy is based on user posture and modulates the assistance to support the wearer's own upper body. The second one adapts to the mass of the lifted object and is a practical implementation of electromyographic control. A third strategy is devised as a generalized combination of the first two. With these strategies, the proposed exoskeleton can quickly adjust to different task conditions (which makes it versatile compared to using multiple, task-specific, devices) as well as to individual preference (which promotes user acceptance). Additionally, the presented implementation is potentially applicable to more powerful exoskeletons, capable of generating larger forces. The different strategies are implemented on the exoskeleton and tested on 11 participants in an experiment reproducing the lifting task. The resulting data highlights that the strategies modulate the assistance as intended by design, i.e., they effectively adjust the commanded assistive torque during operation based on user posture and external mass. The experiment also provides evidence of significant reduction in muscular activity at the lumbar spine (around 30%) associated to using the exoskeleton. The reduction is well in line with previous literature and may be associated to lower risk of injury.

The Effects of Rearfoot Position on Lower Limb Kinematics during Bilateral Squatting in Asymptomatic Individuals with a Pronated Foot Type.

Clinicians frequently assess movement performance during a bilateral squat to observe the biomechanical effects of foot orthotic prescription. However, the effects of rearfoot position on bilateral squat kinematics have not been established objectively to date. This study aims to investigate these effects in a population of healthy adults with a pronated foot type. Ten healthy participants with a pronated foot type bilaterally (defined as a navicular drop >9mm) performed three squats in each of three conditions: barefoot, standing on 10mm shoe pitch platforms and standing on the platforms with foam wedges supporting the rearfoot in subtalar neutral. Kinematic data was recorded using a 3D motion analysis system. Between-conditions changes in peak joint angles attained were analysed. Peak ankle dorsiflexion (p=0.0005) and hip abduction (p=0.024) were significantly reduced, while peak knee varus (p=0.028) and flexion (p=0.0005) were significantly increased during squatting in the subtalar neutral position compared to barefoot. Peak subtalar pronation decreased by 5.33° (SD 4.52°) when squatting on the platforms compared to barefoot (p=0.006), but no additional significant effects were noted in subtalar neutral. Significant changes in lower limb kinematics may be observed during bilateral squatting when rearfoot alignment is altered. Shoe pitch alone may significantly reduce peak pronation during squatting in this population, but additional reductions were not observed in the subtalar neutral position. Further research investigating the effects of footwear and the subtalar neutral position in populations with lower limb pathology is required.