Movement therapy in advanced heart failure assisted by a lightweight wearable robot: a feasibility pilot study

Isabell Anna Just, Denis Fries, Sina Loewe, Volkmar Falk, Nikola Cesarovic, Frank Edelmann, Anna Feuerstein, Florian L Haufe, Michele Xiloyannis, Robert Riener, Felix Schoenrath, Isabell Anna Just, Denis Fries, Sina Loewe, Volkmar Falk, Nikola Cesarovic, Frank Edelmann, Anna Feuerstein, Florian L Haufe, Michele Xiloyannis, Robert Riener, Felix Schoenrath

Abstract

Aims: The aim of this pilot study was to investigate the safety, feasibility, tolerability, and acceptability of an assisted mobilization of advanced heart failure patients, using a lightweight, exoskeleton-type robot (Myosuit, MyoSwiss AG, Zurich, Switzerland).

Methods and results: Twenty patients in functional NYHA class III performed activities of daily life (ADL, n = 10) or participated in a single, standardized, 60 min rehabilitation exercise unit (REU, n = 10) with and without the Myosuit. The outcome assessment included the evaluation of vital signs, adverse events, rates of perceived exertion and dyspnoea (RPE, RPD), the ability to perform ADL or REU, and the individual acceptability. The mean age of the subjects was 49.4 (±11.0) years; 80% were male. The mean left ventricular ejection fraction was 22.1% (±7.4%) and the median NT-proBNP 2054 pg/mL (IQR 677, 3270 pg/mL). In all patients, mobilization with the Myosuit was feasible independently or with minor support. The mean individual difference in the total walking distance of the patients without and with robotic assistance was -26.5 m (95% confidence interval (CI) -142 to 78 m, P = 0.241). No adverse events occurred. RPE and RPD showed no significant difference with or without the device (ADL: RPE -0.1 m, 95% CI -1.42 to 1.62, P = 0.932 and RPD -0.95 m, 95% CI -0.38 to 2.28, P = 0.141; REU: RPE 1.1 m, 95% CI -2.90 to 0.70, P = 0.201 and RPD 0.5 m, 95% CI -2.02 to 1.02, P = 0.435). All median responses in the acceptability questionnaire were positive. The patients felt safe and enjoyed the experience; 85% would be interested in participating in robot-assisted training on a regular basis.

Conclusion: This feasibility pilot trial provides first indications that a robotic exoskeleton-assisted mobilization of patients with advanced heart failure is safe, feasible, well-tolerated, and well-accepted. The results are highly encouraging to further pursue this innovative approach in rehabilitation programmes. This trial was registered at ClinicalTrials.gov: NCT04839133.

Keywords: Exercise training; Exoskeleton; Heart failure; Myosuit; Rehabilitation; Robotic-assisted.

Conflict of interest statement

V.F. has relevant (institutional) financial activities outside the submitted work with following commercial entities: Medtronic GmbH, Biotronik SE & Co., Abbott GmbH & Co. KG, Boston Scientific, Abiomed, Edwards Lifesciences, Berlin Heart, Novartis Pharma GmbH, JOTEC/CryoLife GmbH, Zurich Heart. N.C. reports consulting fees from Abbott Cardiovascular, DiNAQOR. F.E. reports grants from German Research Foundation (DFG), grants from German Ministry of Education and Research, during the conduct of the study; personal fees and non‐financial support from Novartis, grants and personal fees from Boehringer Ingelheim, personal fees from CVRx, Pfizer, Medtronic, grants and personal fees from Servier, personal fees from MSD/Bayer, personal fees from Bayer, personal fees from Resmed, personal fees from Berlin Chemie, grants from Thermo Fischer, personal fees from Vifor Pharma, personal fees from PharmaCosmos, personal fees from Merck, outside the submitted work. R.R. holds a shared patent together with MyoSwiss staff (soft wearable muscle assisting device), is member of the scientific advisory board of MyoSwiss AG and owes a small amount of MyoSwiss AG stocks. F.S. reports institutional grants from Novartis, Abbott, non‐financial support from Medtronic, institutional fees (speaker honoraria) from Orion Pharma and Astra Zeneca outside the submitted work. The other authors declare that there is no conflict of interests.

© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Figures

Figure 1
Figure 1
The Myosuit—an exoskeleton‐type robotic device.
Figure 2
Figure 2
Study design of the Myosuit Feasibility Trial. ADL activities of daily life (including walking, standing, sitting‐standing‐transfer, and stairclimbing). REU, rehabilitation exercise unit.
Figure 3
Figure 3
(A) Ability to perform ADL with and without wearing the Myosuit. The evaluation was performed using a numerical scale from 1–4 (1 = unable, 2 = with major support, 3 = with minor support, 4 = independently). Data presented as mean ± standard deviation. (B) Walked distances of patients in G1 with and without robotic assistance.
Figure 4
Figure 4
RPE and RPD in G1 performing the 6MWT and ADL (A) and G2 performing a REU (B). Data are presented as mean and SD.

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Source: PubMed

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