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A computational design of lower limb amputee rehabilitation using functional electrical stimulation

Lead Research Organisation: University of Birmingham
Department Name: Mechanical Engineering

Abstract

There are more than one million annual amputations globally as a result of vascular diseases, trauma and cancer. Due to the increasing rate of diabetes and the population ageing, a growth of amputation is expected with the prediction that the amputee population will double by 2050. A prosthesis allows a certain restoration of functional mobility after an amputation. However, neither passive nor active prostheses can directly address the fundamental problems of chronic pain and muscle atrophy in millions of amputees worldwide. Chronic amputation-related pain impairs function. In addition, the early decline in the use of the affected limb results in progressive muscle atrophy with strength loss. Concurrently, a mechanical adaption occurs in order to compensate for the collective effects due to limb loss. A common compensation strategy is to overload the intact limbs in terms of time and intensity, which will cause secondary musculoskeletal disorders, further compromising their health-related quality of life.
The project will target the clear unmet needs of amputees by developing a novel functional electrical stimulation (FES) device. A ground-breaking, computational approach based on predictive musculoskeletal modelling will be developed and integrated into the device to design patient-centred rehabilitation. This device has the potential to prescribe the optimal rehabilitation protocol in pain management and mobility enhancement; its long-term application will prevent the onset and progress of musculoskeletal disorders and ultimately improve the quality of life. Dr Ding will receive support from a multidisciplinary team of researchers, business experts, clinicians and patients to ensure the project will impact various stakeholders.
Patients: given the high risk of multiple complications after an amputation, the development of such a new generation of therapies will be attractive to millions of amputees worldwide. Of further importance, are the costs of amputee rehabilitation services. To a civilian amputee, the rehabilitation cost in the first 5 years is approximately $107,200. To the military amputees, the costs will be even higher as they are younger at the time of injury and societal costs will be incurred over a longer period. As such, to prove the efficacy of the novel device in amputee rehabilitation will have a significant socioeconomic impact.
Clinicians: the computational rehabilitation design has the potential to enhance clinical decision making in the rehabilitation pathway. By modelling individual patient's performance and predicting the outcomes in the in-silico environment, the modelling approach will improve patient's satisfaction to current practice. The project will create a collaborative environment for engineers and clinicians to share intellectual investment and make a broad impact of computational modelling and simulation in the clinic.
Medical device industry: the application of FES therapy to the amputee population will directly expand the market size of electrical stimulators. The FES manufacturers could instantiate the rehabilitation protocol in their existing products to fulfil the application or develop a standalone product for amputees. The incorporation of the predictive amputee musculoskeletal model in the product design will lead to a reduced time to market and improved patient outcomes. The long-term FES application will also benefit the manufacturers of FES components such as electrodes, sensors and battery and add a broader socioeconomic impact.
Educational beneficiaries: the project will allow Dr Ding as a STEM (Science, Technology, Engineering and Maths) Ambassador to run activities in local schools focus on the biomechanics applications of STEM subjects. Also, she will disseminate impressive animations and case studies on musculoskeletal modelling and simulation in her lab website to attract a broad range of students to study biomechanics, making a wider academic impact.

Publications

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Bian Q (2022) A Hybrid Method Integrating A Musculoskeletal Model with Long Short-Term Memory (LSTM) for Human Motion Prediction. in Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference

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Bian Q (2024) Gait Intention Prediction Using a Lower-Limb Musculoskeletal Model and Long Short-Term Memory Neural Networks. in IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society

 
Description We developed a pioneering solution using predictive simulation and musculoskeletal modelling techniques. A gait cycle is modelled as an optimal control problem, where customised cost functions enable us to explore how desired mechanical or physiological outcomes can be achieved by investigating musculoskeletal dynamics. For this patient population, we proposed a novel cost function aimed at reducing energy expenditure and mechanical loading in the intact limb. This approach seeks to mitigate the detrimental effects of musculoskeletal compensatory strategies, ultimately improving functional outcomes and reducing long-term complications. The in-silico simulations revealed the need to stimulate residual vastus muscles during stance, satisfying the patient-specific cost function. Our in-vivo lab experiments confirmed the beneficial effects of FES in improving gait performance and reducing pain.
Exploitation Route For the clinical adoption of the novel therapy, several issues remain. First, we need to evaluate its longer-term effects, typically over a six-week cycle, during which the musculoskeletal system adapts. In collaboration with clinicians, patients, and industry partners, we have co-created an initial FES therapy protocol for its repetitive use. This project will enable us to implement the protocol while collecting data to answer key questions, such as retention rates and compliance, and identify the obstacles the clinicians and patients may encounter with longer-term use. The findings will help refine the final protocol agreed upon by all stakeholders.

Secondly, we will conduct a proof-of-concept study of our new technique using wearable IMU sensors for musculoskeletal modelling. This approach will enable us to gather biomechanical data in a cost- and time-efficient manner, eliminating reliance on marker-based motion capture systems and force plates. Furthermore, the novel technique will facilitate large-scale data collection, supporting evidence-based clinical decision-making regarding gait function and its underlying musculoskeletal dynamics, thereby strengthening our follow-on funding application.

We have secured funding support from MRC IAA and are now moving into the next stage of assessing FES therapy. This phase will explore the potential for clinical adoption and commercialization of our novel wearable-based musculoskeletal modeling tool.
Sectors Healthcare

 
Description MRC IAA 2021 University of Birmingham
Amount £2,225,664 (GBP)
Funding ID MR/X502996/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 03/2022 
End 03/2026
 
Title IMU to OpenSense Toolbox 
Description In this study, we developed a whole framework to track human locomotion using IMU sensors, which is a cheaper solution than the camera-based motion tracking technique and has great potential to facilitate large-scale multi-centre clinical trials for which the traditional camera-based motion tracking technique is infeasible. The whole framework is developed using the IMU sensors (Trigno Avanti, Delsys, USA) and an open-source musculoskeletal modelling software toolkit OpenSense (https://simtk.org/projects/bailey2021_imu). A toolbox to convert the IMU data to the OpenSense input data is shared with other musculoskeletal modellers (https://simtk.org/projects/imu2opensense/). 
Type Of Material Model of mechanisms or symptoms - human 
Year Produced 2023 
Provided To Others? Yes  
Impact The study will facilitate large-scale multi-centre clinical trials to track the locomotion of lower limb amputees. In the next step, patients don't need to visit our lab at the University of Birmingham, instead, clinical from the NHS sits will put the sensors on patients and acquire accurate and reliable data based on some simple training. 
URL https://simtk.org/projects/imu2opensense/
 
Description Poornashree Ramamurthy/Consultant in amputee rehabilitation;Christine Singleton/Clinical Specialist Physio in Functional Electrical Stimulation (FES) and Conor Wood/Research Assistant 
Organisation Birmingham Community Healthcare NHS Trust
Department West Midlands Rehabilitation Centre
Country United Kingdom 
Sector Hospitals 
PI Contribution Our collaboration with the West Midland Rehabilitation Centre, Birmingham Community Healthcare NHS Trust is investigating the clinical utility of functional electronic stimulation (FES) that improves mobility and reduces pain (named 'motion study') for NHS patients with one below-knee amputation.
Collaborator Contribution The motion study intervention is taking place at the University of Birmingham (UoB) for the purpose of the experimental data measures, however, the time has been captured by the NHS staff member (Miss Christine Singleton/Clinical Specialist Physio in Functional Electrical Stimulation) attending UoB for the intervention delivery with Dr Ziyun Ding and the NHS medical NHS FES device (ODFS Pace V1); Intervention also utilises additional site appointments prior to and after the motion study which will be organised and delivered by the NHS staff members (Poornashree Ramamurthy/Consultant in amputee rehabilitation and Conor Wood/Research Assistant) at the NHS Trust.
Impact The collaboration is multi-disciplinary involving engineers and NHS clinicians. Under the collaboration, our study protocol (entitled "A computational design of lower limb amputee rehabilitation using functional electrical stimulation"; protocol number: RG_21-137) has been approved by the Health and Social Care Research Ethics Committee; our collaborative study (Ref number: CPMS ID 51737) has been confirmed as being covered by Specialised Commissioning funding for it's incurred Excess Treatment Costs by NIHR Clinical Research Network.
Start Year 2022
 
Title A study of functional electrical stimulation on lower limb amputees 
Description The study will design and evaluate a new rehabilitation intervention using functional electrical stimulation (FES) for people with unilateral transtibial (below knee) amputation. FES is a non-invasive, electrical stimulator. It delivers small amounts of electrical current in the form of pulses into the skin. It is a common and established method in rehabilitation. Some known effects of FES were investigated in several studies e.g. avoiding disuse atrophy, improving muscle strength, muscle force output, and reducing pain. Most of the studies investigated the effect of FES on patients with brain and musculoskeletal injuries, such as stroke, and spinal cord injuries. For the cohort of lower limb amputees, fewer studies exist. However, it is supposed that the effects of FES are similar. The hypothesis of the study is: the application of FES on the lower limb amputees has the potential to reduce pain and improve mobility. Its long-term application has the potential to mitigate the higher risk of musculoskeletal disorders. In this study, based on the experimental measures of lower limb amputees (including their motion during activities of daily living and medical imaging) we will develop a detailed computational model to assess the efficacy of FES on the amputee cohort. The intervention is in its initial development stage. After the patient recruitment; experimental/computational studies we will gather evidence that the new intervention could improve mobility and reduce pain for the amputee population. This is the first application of FES in NHS patients. Therefore the feedback from the initial development stage will help us design a clinical trial. 
Type Health and Social Care Services
Current Stage Of Development Initial development
Year Development Stage Completed 2023
Development Status Under active development/distribution
Impact Participants who involve in the study will have potential improvements in their mobility in their daily activities of living and reduce pain. 
 
Title Model-driven FES therapy improves gait in people with limb loss (MoFit) -- A feasibility study for a randomised control trial 
Description We propose a single-blind, randomized, two-period crossover design to evaluate the safety and efficacy of FES therapy for patients with limb amputation over a six-week application period in home and community settings (IRAS Project ID: 354627). This project collaborates with the BCHC, including Dr Poornashree Ramamurthy -- an amputee consultant -- and her team in the Prosthetics Service; Christine Singleton -- a consultant physiotherapist -- and her team in the FES service. This project partners with OML, the UK's leading FES device provider. In addition to manufacturing and distributing FES devices, OML operates FES clinics across the UK and offers clinical training courses. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Initial development
Year Development Stage Completed 2025
Development Status Under active development/distribution
Impact More than one million people every year undergo a major limb amputation worldwide. This number is predicted to double by 2050 due to the increasing prevalence of diabetes and an ageing population. A limb amputation can lead to long-term effects. While prosthetics allow people to walk again, they do not address chronic pain. Additionally, walking with a prosthesis often results in secondary conditions. People tend to rely more on their unaffected limb, and over time, this uneven weight-bearing increases the risk of joint wear and tear in the unaffected limb, while also weakening the bone and muscle in the affected limb. To address this issue, we have designed a novel therapy using functional electrical stimulation (FES) for this patient group. Our previous lab study shows its treatment effect in one single application. Clear evidence includes improved walking performance and positive patient feedback. One patient, after using the FES, expressed a strong desire to take the device home. Another patient, wrote to us saying, "I have experienced significantly more marked improvements in comfort, walking, standing, weight distribution, and reduced pain." However, for patients to safely use the device in their daily walking activities, many questions remain. We need to test its longer-term effects (i.e., starting from 6 weeks) and understand patient acceptance. If they do not accept it, we need to identify the reasons. Additionally, we need to analyse different outcome measures to assess whether the design is practical, and the outcomes are relevant to the patients' lives. 
 
Description Invite a collaborator from the EU to visit our lab and plan the next grant application for digital rehabilitation for patients with movement impairments. 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Third sector organisations
Results and Impact Invite our international collaborator, Assistant Professor Dr. Eline van der Kruk, from the Faculty of Mechanical Engineering at Delft University of Technology. Dr. van der Kruk leads the BODIES research lab, which focuses on advancing the mechanics of human movement.

During her visit, we will discuss future grant application plans, including a submission for the 2025 MSCA Doctoral Training Network. She will also visit several labs within the School of Engineering and the School of Sport, Exercise, and Rehabilitation Sciences. Additionally, Dr. van der Kruk will present at the regional Cross Birmingham Medical Engineering and Biomechanics Conference 2024, hosted by the School of Engineering at the University of Birmingham.
Year(s) Of Engagement Activity 2024
 
Description Patient group workshop 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact Since June of 2024, we have conducted a series of in-person meetings with patients and clinicians at BCHC in Birmingham to initiate the 6-week FES protocol. These discussions addressed the role of each clinical team, and the time commitment required for each patient's two-period crossover design; patients' walking activity levels, and their willingness to use the device at home. Additionally, we held a meeting with clinicians and FES suppliers during the IFESS 2024 conference in Bath to confirm the in-kind contributions of OML and gather feedback on the protocol. After receiving feedback on the outline, we have extensively exchanged emails with clinicians and FES suppliers, made the necessary amendments, and developed the full application. This co-creation process helped us move on to the next stage with successful grant application to the MRC IAA, starting to asses the safety and efficacy of our FES therapy during 6-weeks of home use
Year(s) Of Engagement Activity 2024