Translating digital healthcare to enhance clinical management: a protocol for an observational study using a digital health technology system to monitor medication adherence and its effect on mobility in people with Parkinson's.

INTRODUCTION: In people with Parkinson's (PwP) impaired mobility is associated with an increased falls risk. To improve mobility, dopaminergic medication is typically prescribed, but complex medication regimens result in suboptimal adherence. Exploring medication adherence and its impact on mobility in PwP will provide essential insights to optimise medication regimens and improve mobility. However, this is typically assessed in controlled environments, during one-off clinical assessments. Digital health technology (DHT) presents a means to overcome this, by continuously and remotely monitoring mobility and medication adherence. This study aims to use a novel DHT system (DHTS) (comprising of a smartphone, smartwatch and inertial measurement unit (IMU)) to assess self-reported medication adherence, and its impact on digital mobility outcomes (DMOs) in PwP. METHODS AND ANALYSIS: This single-centre, UK-based study, will recruit 55 participants with Parkinson's. Participants will complete a range of clinical, and physical assessments. Participants will interact with a DHTS over 7 days, to assess self-reported medication adherence, and monitor mobility and contextual factors in the real world. Participants will complete a motor complications diary (ON-OFF-Dyskinesia) throughout the monitoring period and, at the end, a questionnaire and series of open-text questions to evaluate DHTS usability. Feasibility of the DHTS and the motor complications diary will be assessed. Validated algorithms will quantify DMOs from IMU walking activity. Time series modelling and deep learning techniques will model and predict DMO response to medication and effects of contextual factors. This study will provide essential insights into medication adherence and its effect on real-world mobility in PwP, providing insights to optimise medication regimens. ETHICS AND DISSEMINATION: Ethical approval was granted by London-142 Westminster Research Ethics Committee (REC: 21/PR/0469), protocol V.2.4. Results will be published in peer-reviewed journals. All participants will provide written, informed consent. TRIAL REGISTRATION NUMBER: ISRCTN13156149.

Feasibility and usability of a digital health technology system to monitor mobility and assess medication adherence in mild-to-moderate Parkinson's disease.

Introduction: Parkinson's disease (PD) is a neurodegenerative disorder which requires complex medication regimens to mitigate motor symptoms. The use of digital health technology systems (DHTSs) to collect mobility and medication data provides an opportunity to objectively quantify the effect of medication on motor performance during day-to-day activities. This insight could inform clinical decision-making, personalise care, and aid self-management. This study investigates the feasibility and usability of a multi-component DHTS to remotely assess self-reported medication adherence and monitor mobility in people with Parkinson's (PwP). Methods: Thirty participants with PD [Hoehn and Yahr stage I (n = 1) and II (n = 29)] were recruited for this cross-sectional study. Participants were required to wear, and where appropriate, interact with a DHTS (smartwatch, inertial measurement unit, and smartphone) for seven consecutive days to assess medication adherence and monitor digital mobility outcomes and contextual factors. Participants reported their daily motor complications [motor fluctuations and dyskinesias (i.e., involuntary movements)] in a diary. Following the monitoring period, participants completed a questionnaire to gauge the usability of the DHTS. Feasibility was assessed through the percentage of data collected, and usability through analysis of qualitative questionnaire feedback. Results: Adherence to each device exceeded 70% and ranged from 73 to 97%. Overall, the DHTS was well tolerated with 17/30 participants giving a score > 75% [average score for these participants = 89%, from 0 (worst) to 100 (best)] for its usability. Usability of the DHTS was significantly associated with age (ρ = -0.560, BCa 95% CI [-0.791, -0.207]). This study identified means to improve usability of the DHTS by addressing technical and design issues of the smartwatch. Feasibility, usability and acceptability were identified as key themes from PwP qualitative feedback on the DHTS. Conclusion: This study highlighted the feasibility and usability of our integrated DHTS to remotely assess medication adherence and monitor mobility in people with mild-to-moderate Parkinson's disease. Further work is necessary to determine whether this DHTS can be implemented for clinical decision-making to optimise management of PwP.

Role of Knee and Ankle Extensors' Muscle-Tendon Properties in Dynamic Balance Recovery from a Simulated Slip.

Participants exposed to a simulated slip with forward loss of balance (FLB) develop large lower limb joint moments which may be a limiting factor for those whose muscle-tendon units' (MTUs) properties are deteriorated. Whether the age-related decline in these properties limits participants' capacity to recover their balance following a slip with FLB remains unclear. We combined isokinetic dynamometry, ultrasound and EMG to understand how knee extensor and ankle plantarflexor muscle strength and power, rate of moment development, electromechanical delay, and tendon stiffness affected the balance of young (25.3 ± 3.9 years) and older adults (62.8 ± 7.1 years) when recovering from a single slip with FLB triggered whilst walking on a split-belt instrumented treadmill. Except for the patellar tendon's stiffness, knee extensor and ankle plantarflexor electromechanical delays, older adults' MTUs properties were deteriorated compared to those of young participants (p < 0.05). We found no significant relationship between age or the MTUs properties of participants and balance recovery. These findings provide additional support that neither maximal nor explosive strength training are likely to be successful in preventing a fall for healthy older adults, and that other type of interventions, such as task-specific training that has already proved efficacious in reducing the risk of falling, should be developed.

Biomechanical Mechanisms of Improved Balance Recovery to Repeated Backward Slips Simulated by Treadmill Belt Accelerations in Young and Older Adults.

Aim: Exposure to repeated gait perturbations improves the balance of older adults (OAs) and decreases their risks of falling, but little is known about the underpinning mechanical adjustments. We aimed to quantify the changing temporo-spatial and kinetic characteristics of balance recovery following repeated backward slips to better understand the mechanical adjustments responsible for improved balance. Methods: We exposed 17 young adults (YAs) (25.2 ± 3.7 years) and 17 OAs (62.4 ± 6.6 years) to 10 backward slips simulated on an instrumented treadmill by unilateral backward belt accelerations. We measured the balance of the participants (margin of stability: MoS), balance recovery (nsteps: number of steps necessary to return to a steady gait for at least three consecutive steps), temporo-spatial (step length), and kinetics [ground reaction force (GRF) angle, lower limb joint moments] for 15 steps following each slip. The results were compared with baseline. Results: Participants in both groups improved their MoS and nsteps with repeated exposure to the slips, but no significant effect of age was detected. During the perturbed step, the GRF vector was directed more posteriorly during mid-stance and more anteriorly during push-off than baseline, which resulted in a longer step. These adjustments were maintained from the first (Slip01) to the last (Slip10) slip, and by Slip10 were correlated with better balance (MoS) on the second recovery step. During the first recovery step following Slip01, participants developed lower plantarflexor and larger knee extensor moments whilst taking a shorter step, these adjustments were correlated with poorer balance and were not maintained with repeated slips. Joint moments and step length of the first recovery step returned to normal levels by Slip10. Conclusion: Young adults and OAs improved their balance with repeated slips. The adjustments that were positively correlated with balance (changes in step length, GRF angle) were maintained whilst those that were not (changes in joint moments) were discarded. All the responses observed in Slip10 were observed in Slip01. The observed balance improvements were achieved by refining the initial strategy rather than by developing a new one. The underlying mechanics were correlated with step length of the first recovery steps, which was associated with balance and should be monitored in fall prevention interventions.

Recovery From a Forward Falling Slip: Measurement of Dynamic Stability and Strength Requirements Using a Split-Belt Instrumented Treadmill.

Aim: Falls commonly occur from trips and slips while walking. Recovery strategies from trips and backward falling slips have been extensively studied. However, until recently, forward falling slips (FFSs) have been considered less dangerous and have been understudied. This study aimed first to create an application to realistically simulate FFSs using a split-belt instrumented treadmill and then to understand the biomechanical requirements for young adults to recover from an FFS. Methods: We developed a semi-automatic custom-made application on D-Flow that triggered FFSs by briefly and unexpectedly increasing the speed (a = 5 m·s-2) of the right belt during stance. To validate the protocol, we tested against criteria defined for an ecologically and experimentally valid FFS: unexpected occurrence of the slip, increased foot velocity, forward loss of balance during the slip and consistent perturbation timing. We evaluated the recovery strategies of 17 young adults by measuring dynamic stability, joint moments and ground reaction force (GRF) vector angles before, during and on 15 steps following the FFS. Results: The application successfully triggered FFSs, according to the criteria we defined. Participants' balance returned to normal for a minimum of three consecutive steps in 10.9 (7.0) steps. Recovery from the FFSs was characterised by larger hip flexor and knee extensor moments to support the centre of mass during the slip, and a longer first recovery step with large hip extensor moments to arrest the fall followed by large knee extensor moments to raise and advance the centre of mass into the next step (p < 0.001 compared with normal gait). Subsequent steps progressively returned to normal. Conclusion: This is the first study to experimentally simulate FFSs meeting the aforementioned criteria, and to measure their effects on the dynamic balance and kinetic parameters. The split-belt instrumented treadmill proved a promising tool to better study the mechanisms of falls and recovery. The required large hip and knee joint moments generally agree with findings on trips and backward falling slips and provide an indication of the functional capacities that should be targeted in fall-prevention interventions. These findings should be used to better understand and target the mechanisms of balance loss and falls in older adults following FFSs.

Effective Mechanical Advantage About the Ankle Joint and the Effect of Achilles Tendon Curvature During Toe-Walking.

Aim: To study the causes of locomotor dysfunction, estimate muscle forces, or understand the influence of altered sarcomere and muscle properties and behaviours on whole body function, it is necessary to examine the leverage with which contractile forces operate. At the ankle joint, current methods to quantify this leverage for the plantarflexors do not account for curvature of the Achilles tendon, and so may not be appropriate when studying equinus gait. Thus, novel methodologies need to be developed and implemented to quantify the Achilles tendon moment arm length during locomotion. Methods: Plantarflexor internal moment arm length and effective mechanical advantage of 11 typically developed young adults were calculated throughout stance, while heel-toe walking and voluntarily toe-walking on an instrumented treadmill. Achilles tendon moment arm was defined in two-ways: (1) assuming a straight tendon, defined between the gastrocnemius medialis myotendinous junction and Achilles tendon insertion point, and (2) accounting for tendon curvature, by tracking the initial path of the Achilles tendon from the calcaneal insertion. Results: When accounting for tendon curvature, Achilles tendon moment arm length and plantarflexor effective mechanical advantage did not differ between walking conditions (p > 0.05). In contrast, when assuming a straight tendon, Achilles tendon moment arm length (p = 0.043) and plantarflexor effective mechanical advantage (p = 0.007) were significantly greater when voluntary toe-walking than heel-toe walking in late stance. Discussion: Assuming a straight Achilles tendon led to a greater Achilles tendon moment arm length and plantarflexor effective mechanical advantage during late stance, compared to accounting for tendon curvature. Consequently, plantarflexor muscle force would appear smaller when assuming a straight tendon. This could lead to erroneous interpretations of muscular function and fascicle force-length-velocity behaviour in vivo, and potentially inappropriate and ineffective clinical interventions for equinus gait.

Ankle Motion Is Associated With Soft Tissue Displacement in the Dorsal Thigh: An in vivo Investigation Suggesting Myofascial Force Transmission Across the Knee Joint.

Experiments in cadavers have demonstrated significant mechanical interactions between constituents of myofascial chains. However, evidence for such force transmission effects is scarce under in vivo conditions. The purpose of this trial was to examine the impact of ankle motion on soft tissue displacement of the dorsal thigh. Eleven healthy active individuals (26.8 ± 4.3 years, six males), in prone position and with the knee extended, underwent passive calf stretches (ankle dorsal extension) imposed by an isokinetic dynamometer. High-resolution ultrasound was used to simultaneously capture the displacement of the semimembranosus muscle, which was quantified by means of cross-correlation analysis. Inactivity of the leg muscles was controlled using surface electromyography (EMG). One participant had to be excluded due to major EMG activity during the experiment. According to a one-sample t test testing the difference to the neutral zero position, ankle dorsal extension induced substantial caudal muscle displacements (5.76 ± 2.67 mm, p < 0.0001). Correlation analysis (Spearman), furthermore, revealed a strong association between maximal dorsal extension and semimembranosus motion (rho = 0.76, p = 0.02). In conclusion, the present trial provides initial in vivo evidence for a mechanical force transmission between serially connected skeletal muscles. This means that local alterations of the mechanical tissue properties may modify flexibility in neighboring (superior or inferior) joints.