Comprehensive Intensive Stroke Rehabilitation (COMIRESTROKE)

Charles University, Czech Republic

Status: Enrolling

Conditions: Rehabilitation; Stroke; Physical Therapy Modalities

Treatments: Behavioral: Effectively managed rehabilitation implementing the recommendations of the World Health Organization; Behavioral: Technology based physical therapy; Behavioral: Standard care; Behavioral: Neuroproprioceptive "facilitation, inhibition"

Study type: Interventional

Funder types: Other

Identifiers

NCT05323916

12021 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 4 patient groups, including a placebo group

Neuroproprioceptive "facilitation, inhibition"

Active Comparator group

Description:

According to the doctor's indication, a multidisciplinary team participates in the program. The practitioner from each clinical field (rehabilitation and physical medicine, physiotherapy, occupational therapy, clinical speech therapy and psychology) selects appropriate treatment methodologies for each patient (three hours). In addition, participants undergoes one hour a day of individual physiotherapy on a neurophysiological basis - neuroproprioceptive "facilitation, inhibition", which, by combining appropriate stimuli in a suitable time sequence, maintains optimal motor pathway function and optimal irritability of control or regulation structures.

Treatment:

Behavioral: Neuroproprioceptive "facilitation, inhibition"

Technology based physical therapy

Active Comparator group

Description:

According to the doctor's indication, a multidisciplinary team participates in the program. The practitioner from each clinical field (rehabilitation and physical medicine, physiotherapy, occupational therapy, clinical speech therapy and psychology) selects appropriate treatment methodologies for each patient (three hours). In addition, they will undergo physiotherapy for an hour a day using the implementation of modern technologies based on the principles of sensorimotor learning, i.e. repeating specific and targeted functions in different environments / conditions in order to strengthen the memory footprint and initiate structural changes in the central nervous system. According to the indication, participants will be offered one of the robotic systems using an exoskeleton (Gloreha, Erigo and Meditutor, Lokomat and Ekso) or a therapy using virtual environment.

Treatment:

Behavioral: Technology based physical therapy

Effectively managed rehabilitation implementing the recommendations of the World Health Organization

Experimental group

Description:

The concept of therapy implementing the ICF model is based on a comprehensive, so-called biopsychosocial approach to the patient and his/her disease (four hours). The key is to set individual goals of the therapy together with the rehabilitator and with the use of so-called ICF core sets, which individually take into account the given situation of the rehabilitated person. This approach includes interdisciplinary diagnosis of the current condition, i.e. not only based on the diagnosis, but also on the functional status and activities performed, it also takes into account the socio-psychological background of the patient.

Treatment:

Behavioral: Effectively managed rehabilitation implementing the recommendations of the World Health Organization

Control group

Placebo Comparator group

Description:

Participants will undergo standard care.

Treatment:

Behavioral: Standard care