AUTHOR=Řasová Kamila , Martinková Patrícia , Vařejková Michaela , Miznerová Barbora , Pavlíková Markéta , Hlinovská Jana , Hlinovský David , Philippová Štěpánka , Novotný Michal , Pospíšilová Karolína , Biedková Paula , Vojíková Romana , Havlík Jan , O'Leary Valerie Bríd , Černá Marie , Bartoš Aleš , Philipp Tom 

TITLE=COMIRESTROKE—A clinical study protocol for monitoring clinical effect and molecular biological readouts of COMprehensive Intensive REhabilitation program after STROKE: A four-arm parallel-group randomized double blinded controlled trial with a longitudinal design

JOURNAL=Frontiers in Neurology

VOLUME=Volume 13 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.954712

DOI=10.3389/fneur.2022.954712

ISSN=1664-2295

ABSTRACT=Introduction
While the role of physiotherapy as part of a COMprehensive Intensive REhabilitation Programs after STROKE (COMIRESTROKE) is indisputable, clear evidence concerning the effectiveness of different physiotherapy approaches are still lacking. In this study, three kinds of COMIRESTROKE will be compared with standard care. Moreover, focus will be placed on the identification of novel biological molecules reflective of effective rehabilitation. Long non-coding RNAs (lncRNAs) are transcripts (>200 bps) of limited coding potential, which have recently been recognised as key factors in neuronal signalling pathways in ischemic stroke and as such, may provide a valuable readout of patient recovery and neuroprotection during therapeutic progression. 
Methods and analysis
Adults after the first ischemic stroke in an early sub-acute phase with motor disability will be randomly assigned to one of four groups. Three groups will undergo an inpatient COMIRESTROKE intervention (4 hours/day for 3 weeks) of different types: COMIRESTROKE – ICF using the International Classification of Functioning, disability and health model as a guide; COMIRESTROKE – NEFI implementing neuroproprioceptive “facilitation and inhibition” physiotherapy; COMIRESTROKE – TECH implementing technology-based physiotherapy; CONTROL standard inpatient care. Primary (the Goal Attainment Scale, the Patient-Reported Outcomes Measurement Information System, and the World Health Organization Disability Assessment Schedule) and secondary (motor, cognitive, psychological, speech and swallowing functions, functional independence) outcomes will be measured. A blood sample will be obtained upon consent (20mls; representing pre-rehabilitation molecular) before and after the inpatient program. Primary outcomes will be followed up again three and twelve months after the end of the program. 
The overarching aim of this study is to determine the effectiveness of various rehabilitation approaches implemented by patients post ischemic stroke via analysis of primary, secondary and long non-coding RNA readouts.  This clinical trial will offer an innovative approach not previously tested and will provide new complex analysis along with public assessable molecular biological evidence of various rehabilitation methodology for the alleviation of the effects of ischemic stroke. Trial registration number: NCT05323916.