A bidirectional fabric-based soft robotic glove for hand function assistance in patients with chronic stroke.

BACKGROUND: Chronic stroke patients usually experience reduced hand functions, impeding their ability to perform activities of daily living (ADLs) independently. Additionally, improvements in hand functions by physical therapy beyond six months after the initial onset of stroke are much slower than in the earlier months. As such, chronic stroke patients could benefit from an assistive device to enhance their hand functions, allowing them to perform ADLs independently daily. In recent years, soft robotics has provided a novel approach to assistive devices for motor impaired individuals, offering more compliant and lightweight alternatives to traditional robotic devices. The scope of this study is to demonstrate the viability of a fabric-based soft robotic (SR) glove with bidirectional actuators in assisting chronic stroke study participants with hand impairments in performing ADLs. METHODS: Force and torque measurement tests were conducted to characterize the SR Glove, and hand functional tasks were given to eight chronic stroke patients to assess the efficacy of the SR Glove as an assistive device. The tasks involved object manipulation tasks that simulate ADLs, and the series of tasks was done by the participants once without assistance for baseline data, and once while using the SR Glove. A usability questionnaire was also given to each participant after the tasks were done to gain insight into how the SR Glove impacts their confidence and reliance on support while performing ADLs. RESULTS: The SR Glove improved the participants' manipulation of objects in ADL tasks. The difference in mean scores between the unassisted and assisted conditions was significant across all participants. Additionally, the usability questionnaire showed the participants felt more confident and less reliant on support while using the SR Glove to perform ADLs than without the SR Glove. CONCLUSIONS: The results from this study demonstrated that the SR Glove is a viable option to assist hand function in chronic stroke patients who suffer from hand motor impairments.

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 proprioceptive stimulation using a soft robotic glove on motor activation and brain connectivity in stroke survivors.

OBJECTIVE: Soft-robotic-assisted training may improve motor function during post-stroke recovery, but the underlying physiological changes are not clearly understood. We applied a single-session of intensive proprioceptive stimulation to stroke survivors using a soft robotic glove to delineate its short-term influence on brain functional activity and connectivity. APPROACH: In this study, we utilized task-based and resting-state functional magnetic resonance imaging (fMRI) to characterize the changes in different brain networks following a soft robotic intervention. Nine stroke patients with hemiplegic upper limb engaged in resting-state and motor-task fMRI. The motor tasks comprised two conditions: active movement of fingers (active task) and glove-assisted active movement using a robotic glove (glove-assisted task), both with visual instruction. Each task was performed using bilateral hands simultaneously or the affected hand only. The same set of experiments was repeated following a 30-minute treatment of continuous passive motion (CPM) using a robotic glove. MAIN RESULTS: On simultaneous bimanual movement, increased activation of supplementary motor area (SMA) and primary motor area (M1) were observed after CPM treatment compared to the pre-treatment condition, both in active and glove-assisted task. However, when performing the tasks solely using the affected hand, the phenomena of increased activity were not observed either in active or glove-assisted task. The comparison of the resting-state fMRI between before and after CPM showed the connectivity of the supramarginal gyrus and SMA was increased in the somatosensory network and salience network. SIGNIFICANCE: This study demonstrates how passive motion exercise activates M1 and SMA in the post-stroke brain. The effective proprioceptive motor integration seen in bimanual exercise in contrast to the unilateral affected hand exercise suggests that the unaffected hemisphere might reconfigure connectivity to supplement damaged neural networks in the affected hemisphere. The somatosensory modulation rendered by the intense proprioceptive stimulation would affect the motor learning process in stroke survivors.

Brain-Computer Interface-Based Soft Robotic Glove Rehabilitation for Stroke.

OBJECTIVE: This randomized controlled feasibility study investigates the ability for clinical application of the Brain-Computer Interface-based Soft Robotic Glove (BCI-SRG) incorporating activities of daily living (ADL)-oriented tasks for stroke rehabilitation. METHODS: Eleven recruited chronic stroke patients were randomized into BCI-SRG or Soft Robotic Glove (SRG) group. Each group underwent 120-minute intervention per session comprising 30-minute standard arm therapy and 90-minute experimental therapy (BCI-SRG or SRG). To perform ADL tasks, BCI-SRG group used motor imagery-BCI and SRG, while SRG group used SRG without motor imagery-BCI. Both groups received 18 sessions of intervention over 6 weeks. Fugl-Meyer Motor Assessment (FMA) and Action Research Arm Test (ARAT) scores were measured at baseline (week 0), post- intervention (week 6), and follow-ups (week 12 and 24). In total, 10/11 patients completed the study with 5 in each group and 1 dropped out. RESULTS: Though there were no significant intergroup differences for FMA and ARAT during 6-week intervention, the improvement of FMA and ARAT seemed to sustain beyond 6-week intervention for BCI-SRG group, as compared with SRG control. Incidentally, all BCI-SRG subjects reported a sense of vivid movement of the stroke-impaired upper limb and 3/5 had this phenomenon persisting beyond intervention while none of SRG did. CONCLUSION: BCI-SRG suggested probable trends of sustained functional improvements with peculiar kinesthetic experience outlasting active intervention in chronic stroke despite the dire need for large-scale investigations to verify statistical significance. SIGNIFICANCE: Addition of BCI to soft robotic training for ADL-oriented stroke rehabilitation holds promise for sustained improvements as well as elicited perception of motor movements.