AN INTENSIVE REHABILITATION SETTING INVOLVING NEW TECHNOLOGIES IN PATIENTS AFTER STROKE: PRELIMINARY RESULTS OF A MULTICENTRE SINGLE ARM FEASIBILITY TRIAL

C. Schuster-Amft1,2,3, J. Kool4, C. Müller5, S. Wieser6, M. Schwab7, C. Möller8, C. Ziller1, H. Rosemeyer4, M. Ernst9, L. Reicherzer9, R. Schweinfurther8, B. Bujan10, M. Kluge10, L. Schmid10, V. Klamroth-Marganska11, G. Greitemann10, M. Wirz9
1Reha Rheinfelden, Research Department, Rheinfelden, Switzerland, 2University of Basel, Department of Sport, Exercise and Health, Basel, Switzerland, 3Bern University of Applied Science, Institute for Rehabilitation and Performance Technology, Burgdorf, Switzerland, 4Clinics Valens, Valens, Switzerland, 5Hocoma AG, DIH Medical Group, Volketswil, Switzerland, 6Zurich University of Applied Sciences, Institute of Health Economics, School of Management and Law, Winterthur, Switzerland, 7ETH Zurich, Department of Health Science and Technology, Zurich, Switzerland, 8Rehabilitation Clinic Zihlschlacht, Zihlschlacht, Switzerland, 9Zurich University of Applied Sciences, Institute of Physiotherapy, School of Health Professions, Winterthur, Switzerland, 10Clinic Lengg, Zurich, Switzerland, 11Zurich University of Applied Sciences, Institute of Occupational Therapy, School of Health Professions, Winterthur, Switzerland

Background: After a stroke, patients often suffer from hemiparesis, which limits their body functions, activities, and participation in activities of daily living. Modern neurorehabilitation is characterised as intensive, repetitive, and task-oriented. Technology-assisted training includes robotics and other therapies such as sensor-based therapy. This rehabilitation approach seems a cost-efficient way to intensify therapy for patients after stroke and has shown promising potential in improving impairments and disabilities related to the upper extremity (UE) and lower extremity.

Purpose: The aim was to develop and investigate training concepts involving technology-assisted training, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity while keeping the motivation of patients high. The evaluation focuses on implementation feasibility and acceptability, practicability, and costs.

Methods: In a multicentre, longitudinal single arm feasibility design, in- or outpatients after their first-ever stroke after the finalisation of their primary rehabilitation phase were included. Intervention included 5x 45min of technology-assisted training per day for 3-5 days/week for 4 weeks. Primary outcome was feasibility of the intensive technology-based training. Secondary outcomes focussed on intervention-related outcomes (frequency, duration, adherence), patient-related outcomes (FIM, SIS, BBT, FAC, 10mWT, CMSA walking index, BBS, Borg scale, global impression of change, FMS), and costs-specific outcomes (5Q-5D, patient-therapist ratio). The study was registered with clinicaltrials.gov: NCT03641651.

Results: From the 788 screened patients between January 2019 and Mai 2020 were 30 patients eligible for study inclusion. Only 14 out of the 30 eligible patients participated (age 60.8±12.5; 4 females; 10x CVI; MoCA 24.9±2.8; FIM 90±25.8, FAC 2.8±1.4). Main exclusion criteria were no resulting hemiparesis (n=247), no first-ever stroke (n=392), impaired cognition or neuropsychological impairment (n=336), respiratory or cardiovascular impairment (n=100), and instable fractures (n=33).
Overall, patients received 727 technology-assisted training interventions and trained between 12 and 21 days and between 2 and 7 hours/day. Training adherence was best for training sessions lasting between 16 and 30 minutes or between 31 and 45 minutes. Training sessions with a duration of less than 15 or more than 45 minutes were not reasonable. About 8% of the planned training sessions were not carried out due to various reasons. No adverse events related to the intensive training regime were reported. 
Detectable improvements were observed in UE function, physical functions, balance, and health-related quality of life.
Study and assessment analyses are ongoing. Final results are expected in autumn 2020.

Conclusion(s): The implemented high-intensity technology-assisted training was accepted, safe, and partly feasible for in- or outpatients after a stroke. Patient screening-eligibility ratio was low. Further research is required to provide guidance regarding the most effective technology, the optimum intensity and training parameters.

Implications: The present study showed that an intensive technology-assisted training with up to 5x 45min per day seems a reasonable approach to intensify stroke rehabilitation.

Funding, acknowledgements: The study was partially funded by an anonymous foundation.

Keywords: Stroke, feasibility, high intensity technology-assisted training

Topic: Innovative technology: robotics

Did this work require ethics approval? Yes
Institution: Ethics Committee of the Canton Zurich
Committee: With Ethics Committee of Eastern Switzerland and Central- and North-western Switzerland
Ethics number: 2018-01214


All authors, affiliations and abstracts have been published as submitted.

Back to the listing