Abstract
Objective: This study set out to co-design a wearable Focal Muscle Vibration (FMV) device and test its feasibility as a rehabilitation tool to reduce spasticity and improve upper limb function in stroke population. Methods: The objective was achieved through carrying out: a) a semi-structured workshop involving chronic stroke patients, clinicians and researchers to gather systematic user feedback, b) changes to the device design based on this feedback, c) feasibility study comparing effectiveness of 40 minutes of INTERVENTION (FMV+ conventional therapy) with CONTROL (conventional therapy alone), in reducing spasticity and improving upper limb function in 10 stroke participants, d) Quantitative (Fugl Meyer Upper Limb (FMUL), Modified Ashworth (MASh), Pittsburgh Rehabilitation Participation Scale (PRPS), Recruitment Rate and Retention Rate)) and Qualitative (verbal and written feedback), measures to assess participants perception of the wearable technology and its potential as a rehabilitation tool in reducing spasticity and improving function. Results: Participant recruitment and retention rates were high (>80%) along with high PRPS score (6/6), indicating high level of participant engagement throughout the study. FMV intervention improved FMUE scores compared to the Control however did not improve MASh scores. Discussion/Conclusion: This study systematically investigated a wearable FMV device to reduce spasticity and/or improve upper limb function in stroke patients, from co-designing a device with patients and clinicians to carrying out a feasibility study. Clinical outcome measure indicates technology’s potential in improving upper limb function but reduction in spasticity was non-significant, potentially due to small population and duration of intervention. Participants feedback on usability the and acceptability of the technology was also highly positive, indicating its potential as a transformative rehabilitation tool. Clinical and Translational Impact—The Focal Muscle Vibration (FMV) device co-developed and tested in this study has significant potential as a wearable, easy to use, rehabilitation aid to improve upper-limb function in stroke patients.
| Original language | English |
|---|---|
| Pages (from-to) | 354 - 364 |
| Number of pages | 11 |
| Journal | IEEE Journal of Translational Engineering in Health and Medicine |
| Volume | 13 |
| Early online date | 18 Jul 2025 |
| DOIs | |
| Publication status | Published - 2025 |
Bibliographical note
The authors would like to sincerely thank all the stroke volunteers who participated in the experiments for this study. They would like to thank Dr. Jonathan Sinclair (Chartered Statistician) for his expert advice on statistical analyses of this study.Funding
The work of Amit N. Pujari was supported by the Royal Academy of Engineering, U.K., through the \u2018\u2018Industrial Fellowship\u2019\u2019 and Research England \u2018\u2018Proof of Concept Funding.\u2019\u2019 This work involved human subjects or animals in its research. Approval of all ethical and experimental procedures and protocols was granted by the Ethical Review Committee of the University of Hertfordshire under Application No. SPECS/SF/UH/05488, and performed in line with the Declaration of Helsinki. This article has supplementary downloadable material available at https://doi.org/10.1109/JTEHM.2025.3590582, provided by the authors.
| Funders | Funder number |
|---|---|
| Royal Academy of Engineering | \u2018\u2018Industrial Fellowship\u2019\u2019 |
Keywords
- wearable rehabilitation
- Focal muscle vibration
- spasticity
- stroke rehabilitation
- upper limb function