Clinical trial NCT05323916: Comprehensive Intensive Stroke Rehabilitation
Official title: Motor Recovery Following the Comprehensive Intensive Rehabilitation Program After Stroke Implementing the International Classification of Functioning, Disability and Health Model: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Rehabilitation
Physical Therapy Modalities
Keywords: Technology
Goals
Neuroproprioceptive "facilitation and inhibition"
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Thomayer University Hospital
name: Academy of Science Czech Republic
name: Ministry of Health, Czech Republic
name: Vascular surgery, University hospital Královské Vinohrady, Prague
First posted: 2022-04-12
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Double Blinded Controlled Trial with a longitudinal design
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aim to assess the effectiveness of the Comprehensive Intensive Rehabilitation Program After Stroke implementing the International Classification of Functioning, Disability and Health model, and to compare it with two cohorts receiving Comprehensive Intensive Rehabilitation Program After Stroke of the same length but different in physical therapy content (program implementing modern technological approach and neuroproprioceptive "facilitation and inhibition"). Moreover, control group will undergo standard care.

Detailed description: Aim of this study is to define the predictors of effective rehabilitation after stroke. In order to compare the improvement from many different aspects, a wide range of patient characteristic, self-report measures and clinical assessments according to framework of the International Classification of Functioning, Disability and Health (ICF) model, and other data will be collected. The investigators consider, as the most important aspect, the subjective feelings of the participants about how they improved. Therefore, the Goal Attainment scale together with the Patient-reported Outcomes Measurement Information Global Health, and the World Health Organization Disability Assessment Schedule were chosen as primary outcomes. As secondary outcomes, will be measured the motor, cognitive, psychological, speech and swallowing functions and the functional independence. Moreover, focus will be placed on the identification of novel biological molecules reflective of effective rehabilitation.

This clinical trial will test the following scientific hypotheses:

I. COMIRESTROKE under all three settings has a positive influence on all outcomes and higher effect than control group. .

II. COMIRESTROKE - ICF will have the highest impact on primary outcomes (GAS, PROMIS, WHODAS 2.0) and on such secondary outcomes that were identified as treatment goals. Furthermore, it is expected that the highest impact will be on the primary outcomes in the follow-up (three and twelve months after finishing the rehabilitation).

III. COMIRESTROKE - NEFI will have the highest effect on the secondary outcomes, mainly on motor functions. Moreover, it will most significantly lead to the initiation of plastic and adaptive processes, assessed by the level of lncRNAs in the peripheral blood.

IV. The most important predictor of effective rehabilitation will be the level of disability at admission time; however, the content of the rehabilitation will have an impact on perceived, clinical, and physiological changes of the rehabilitant.

Eligibility criteria: Inclusion Criteria:

* adults
* after first ischemic stroke
* early sub-acute phase
* slight to moderately severe disability \[2 - 4 on the Modified Rankin Scale\]
* 0 - 2 on the Pre-Stroke Modified Rankin Score
* potential to accept 4 hours of comprehensive rehabilitation per day and to profit from physiotherapy
* minimal or moderate motor deficit of upper or lower extremities (on NIHSS Item 5 or 6 scores 1-3 points)
* able to perform activities of daily living prior to stroke event (0 - 2 on the Pre-Stroke Modified Rankin Score)
* Czech is participants' native language or its knowledge is at the level of the mother tongue

Exclusion Criteria:

* low level of consciousness (vegetative state and/or minimally conscious state); severe cognitive decline that would interfere with administration of the tests, premorbid illiteracy, severe visual and/or auditory deficit that would prevent proper completion of the tests
* behavioural disorders and/or lack of cooperation with therapist
* severe medical problems with a poor prognosis, (e.g., severe frailty, advanced and incurable cancer, fracture, cardiovascular disorders as chronic heart failure NYHA III, IV, symptomatic coronary artery disease Angina Severity Class III, IV, respiratory insufficiency as chronic obstructive pulmonary disease GOLD IV, and other severe disease)

Primary outcomes:
measure: Change from Baseline Patient-reported Outcomes Measurement Information System - Global Health at 3 weeks, 3 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up assessments (3 and 12 months after the admission respectively)
measure: Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 3 weeks, 3 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).
measure: Change from Baseline Goal Attainment scale at 3 weeks, 3 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).
Secondary outcomes:
measure: Change from Baseline Jamar Hydraulic Hand Dynamometer at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline a power of the signal in band from frequency 1 to 2 at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline a frequency for which the smoothed power spectral density is maximal at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Nine Hole Peg Test at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Action Research Arm Test at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Motor Activity Log at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Timed Up And Go at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Berg Balance Scale at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline The 10 Metre Walk Test at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline The 6 Minute Walk Test at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Functional Independence Measure at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline The Gugging Swallowing Screen at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline The 3F Test - Dysarthric Profile at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline The Mississippi Aphasia Screening Test at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Image Naming Test at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Amnesia Light and Brief Assessment at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Naming Pictures and Their Equipment at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline Neuro - Quality of Life depression at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
measure: Change from Baseline The Montreal Cognitive Assessment at 3 weeks
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Other outcomes:
measure: Change from Baseline the serum level of Long non-coding ribonucleic acid (lncRNA) at 3 weeks, 3 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up at 3 and 12 months.
Locations:
city: Prague
country: Czechia
facility: Thomayer University Hospital
Study officials:
affiliation: Third Faculty of Medicine Charles University
name: Kamila Řasová, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasova K, Martinkova P, Varejkova M, Miznerova B, Pavlikova M, Hlinovska J, Hlinovsky D, Philippova S, Novotny M, Pospisilova K, Biedkova P, Vojikova R, Havlik J, O'Leary VB, Cerna M, Bartos A, Philipp T. 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. Front Neurol. 2022 Nov 1;13:954712. doi: 10.3389/fneur.2022.954712. eCollection 2022.