Comprehensive Intensive Stroke Rehabilitation

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Description

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.

Study Overview

Start Date
May 1, 2022
Completion Date
January 15, 2025
Enrollment
280
Date Posted
April 12, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Thomayer University Hospital
Prague 140 59, Czechia

Eligibility

Minimum Age (years)
18
Maximum Age (years)
85
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)

Study Contact Info

Study Contact Name
Kamila Řasová, Dr.
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT05323916