Using early health economic modeling to inform medical innovation development: a soft robotic sock in poststroke patients in Singapore.

OBJECTIVES: Based on a real-world collaboration with innovators in applying early health economic modeling, we aimed to offer practical steps that health technology assessment (HTA) researchers and innovators can follow and promote the usage of early HTA among research and development (R&D) communities. METHODS: The HTA researcher was approached by the innovator to carry out an early HTA ahead of the first clinical trial of the technology, a soft robotic sock for poststroke patients. Early health economic modeling was selected to understand the potential value of the technology and to help uncover the information gap. Threshold analysis was used to identify the target product profiles. Value-of-information analysis was conducted to understand the uncertainties and the need for further research. RESULTS: Based on the expected price and clinical effectiveness by the innovator, the new technology was found to be cost-saving compared to the current practice. Risk reduction in deep vein thrombosis and ankle contracture, the incidence rate of ankle contracture, the compliance rate of the new technology, and utility scores were found to have high impacts on the value-for-money of the new technology. The value of information was low if the new technology can achieve the expected clinical effectiveness. A list of parameters was recommended for data collection in the impending clinical trial. CONCLUSIONS: This work, based on a real-world collaboration, has illustrated that early health economic modeling can inform medical innovation development. We provided practical steps in order to achieve more efficient R&D investment in medical innovation moving forward.

Effect of a Soft Robotic Sock Device on Lower Extremity Rehabilitation Following Stroke: A Preliminary Clinical Study With Focus on Deep Vein Thrombosis Prevention.

BACKGROUND AND OBJECTIVE: Immobility of the lower extremity due to medical conditions such as stroke can lead to medical complications such as deep vein thrombosis or ankle contracture, and thereafter prolonged recovery process of the patients. In this preliminary clinical study, we aimed to examine the effect of a novel soft robotic sock device, capable of providing assisted ankle exercise, in improving blood flow in the lower limb to prevent the complication of strokes such as deep vein thrombosis and joint contracture. METHODS: Stroke patients were recruited (n = 17) to compare patients using the conventional pneumatic compression device with our robotic sock device on separate days. The primary outcome was to compare the venous flow profile of the superficial femoral vein in terms of the time average mean velocity and volumetric flow. The secondary outcome was to identify the ankle joint range of motion with the assistance of the device. RESULTS: We noted improvements in the venous profile at the early phase of the device use, though its efficacy seemed to drop with time, as compared to the IPC device, where there was a significant improvement in the venous profile. The ankle joint dorsiflexion-plantarflexion range of motion assisted by the device was 11.5±6.3°. Conclusion and clinical impact: The current version of our sock device appears to be capable of improving venous blood flow in the early phase of device use and assisting with ankle joint exercise. The insights from this preliminary clinical study will serve as the basis for further improvement of the device and subsequent conduct of a longitudinal clinical trial. FUNDING: National Health Innovation Centre Singapore (NHIC) grant, R-172-000-391-511, MOE AcRF Tier 1 R-397-000-301-114.

Design, characterisation and evaluation of a soft robotic sock device on healthy subjects for assisted ankle rehabilitation.

Motor impairment is one of the common neurological conditions suffered by stroke patients, where this chronic immobility together with the absence of early limb mobilisation can lead to conditions such as joint contracture with spastic limbs. In this study, a soft robotic sock device was developed, which can provide compliant actuation to the ankle joint in the early stage of stroke recovery. The device is fitted with soft extension actuators and when the actuators are inflated, they extend and guide the foot into plantarflexion; upon deflation, the actuators will resume their initial conformations. Each actuator is linked to a pneumatic pump-valve control system that injects pressurised air into or release air from the system. In this study, the design and characterisation of the soft actuators will be presented, where the theoretical and experimental forces generated by the actuators were compared. The performance of the device was also evaluated on healthy subjects and the results had shown that the device was able to move the subjects' ankles into cycles of dorsiflexion-plantarflexion, in the absence of voluntary muscle effort. The findings suggested that the soft wearable robotic device was capable of assisting the subjects in performing repeated cycles of ankle flexion.

Effects of Mattress Material on Body Pressure Profiles in Different Sleeping Postures.

OBJECTIVES: This study compared the body contact pressure profiles of 2 types of mattresses: latex and polyurethane. METHODS: Twenty participants were required to lie down on the different mattresses in 3 different postures for 6 minutes, and their body contact pressure profiles were recorded with a pressure mat sensor. RESULTS: The data indicated that the latex mattress was able to reduce the peak body pressure on the torso and buttocks and achieve a higher proportion of low-pressure regions compared with the polyurethane mattress. CONCLUSIONS: Latex mattress reduced peak body pressure and achieved a more even distribution of pressure compared with polyurethane mattress across different sleeping postures.

Waardenburg syndrome type II in a Chinese patient caused by a novel nonsense mutation in the SOX10 gene.

OBJECTIVE: Waardenburg syndrome is a congenital genetic disorder. It is the most common type of syndromic hearing impairment with highly genetic heterogeneity and proved to be related by 6 genes as follows: PAX3, MITF, SNAI2, EDN3, EDNRB and SOX10. This article aims to identify the genetic causes of a Chinese WS child patient. METHODS: A Chinese WS child was collected for clinical data collection by questionnaire survey. DNA samples of proband and his parents were extracted from peripheral blood samples. Six candidate genes were sequenced by the Trusight One sequencing panel on the illumina NextSeq 500 platform. RESULTS: A novel nonsense heterozygous mutation was found in the coding region of exon 2 in the SOX10 gene of proband. The novel nonsense heterozygous mutation could cause the replacement of the 55th lysine codon by stop codon (484T > C, C142R) and further more possibly cause terminating the protein translation in advance. However, both proband's parents had no mutation of genes above mentioned. CONCLUSION: The gene mutation of SOX10 [NM_006941.3 c.163A > T] is a novel nonsense mutation. No record of this mutation has been found in dbSNP, HGMD, 1000 Genomes Project, ClinVar and ESP6500 databases. It meets the condition of PS2 of strong evidence in 2015 ACMG Standards and Guidelines.