StrokeCOMIRESTROKENCT05323916
Comprehensive Intensive Stroke Rehabilitation
A study testing Neuroproprioceptive "facilitation, inhibition", Technology based physical therapy and Effectively managed rehabilitation implementing the recommendations of the World Health Organization in people with Stroke and Rehabilitation, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Rehabilitation, Physical Therapy Modalities
- What is being tested?
- Neuroproprioceptive "facilitation, inhibition", Technology based physical therapy and Effectively managed rehabilitation implementing the recommendations of the World Health Organization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2022to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Thomayer University Hospital
Prague, 140 59
Tom Philip, MD, Ph.D., +420737273589, tom.philipp@ftn.cz
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Stroke, Rehabilitation, Physical Therapy Modalities
- Being tested
- Neuroproprioceptive "facilitation, inhibition", Technology based physical therapy, Effectively managed rehabilitation implementing the recommendations of the World Health Organization, Standard care
- Keywords
- Technology, Goals, Neuroproprioceptive "facilitation and inhibition"
- Medical subject headings
- Stroke, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroproprioceptive "facilitation, inhibition"Behavioural
Participants will undergo a standard comprehensive intensive rehabilitation program three hours a day for three weeks and moreover one hour a day of neuroproprioceptive "facilitation, inhibition" physical therapy.
Technology based physical therapyBehavioural
Participants will undergo a standard comprehensive intensive rehabilitation program three hours a day for three weeks and moreover one hour a day of technology based physical therapy.
Effectively managed rehabilitation implementing the recommendations of the World Health OrganizationBehavioural
Participants will undergo a four hour a day for three weeks of effectively managed comprehensive intensive rehabilitation implementing the recommendations of the World Health Organization.
Standard careBehavioural
Participants will undergo standardly provided care including face to face physiotherapy (bed mobility, transfers, gait, therapeutic exercises, positioning, education).
| Study group | Role | What they receive |
|---|---|---|
| Neuroproprioceptive "facilitation, inhibition" | Active comparator | 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. Receives: Behavioral: Neuroproprioceptive "facilitation, inhibition" |
| Technology based physical therapy | Active comparator | 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. Receives: Behavioral: Technology based physical therapy |
| Effectively managed rehabilitation implementing the recommendations of the World Health Organization | Experimental | 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. Receives: Behavioral: Effectively managed rehabilitation implementing the recommendations of the World Health Organization |
| Control group | Placebo comparator | Participants will undergo standard care. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Patient-reported Outcomes Measurement Information System - Global Health at 3 weeks, 3 and 12 months
a 10 item scale that assesses an individual's physical, mental, and social health where a standardized score with a mean of 50 and a standard deviation of 10, so a person with a T-score of 40 is one SD below the mean.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up assessments (3 and 12 months after the admission respectively)
Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 3 weeks, 3 and 12 months
the 36-item questionnaire, higher score means higher disability
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).
Change from Baseline Goal Attainment scale at 3 weeks, 3 and 12 months
Each goal is rated on 5-point scale (-2 much less than expected, 0 achieved the expected level, 2 much more than expected). Higher score means a better outcome.
Measured: 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 (19)
Change from Baseline Jamar Hydraulic Hand Dynamometer at 3 weeks
isometric grip force and strength. The higher value, the better function (higher strength)
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline a power of the signal in band from frequency 1 to 2 at 3 weeks
The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - a power of the signal in band from f1 to f2 - lower value, lower tremor.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline a frequency for which the smoothed power spectral density is maximal at 3 weeks
The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - a frequency for which the smoothed power spectral density is maximal - lower value, lower tremor.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Nine Hole Peg Test at 3 weeks
A client takes the pegs from a container, one by one, and places them into the holes on the board, as quickly as possible. Shorter times reflect better function.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Action Research Arm Test at 3 weeks
A 19 item observational measure to assess upper extremity performance (coordination, dexterity and functioning). Higher score means better function.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Motor Activity Log at 3 weeks
Measure real-world upper extremity function. The MAL adopts a 6-point ordinal scale (0 - 5). Higher score means better function.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Timed Up And Go at 3 weeks
The subject stands up from a chair, walks 3m, turns back, and sits down again as quickly and safely as possible while being timed. Higher times reflect worse mobility.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Berg Balance Scale at 3 weeks
A 14-task scale that requires subjects to maintain their balance in positions and tasks of increasing difficulty (0 - 56). Higher score means better balance.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The 10 Metre Walk Test at 3 weeks
A performance measure used to assess walking speed in meters per second over 10 meters. Shorter times reflect better mobility.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The 6 Minute Walk Test at 3 weeks
A long walking capacity test recording the maximal distance a subject walks at the fastest speed possible in 6 minutes. The more distance covered, the better the walking performance is.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Functional Independence Measure at 3 weeks
An 18-item measurement tool that explores an individual's physical, psychological and social function. Higher score is better (higher independence).
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The Gugging Swallowing Screen at 3 weeks
It assesses the severity of aspiration risk (0 - 20). Higher score means better function.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The 3F Test - Dysarthric Profile at 3 weeks
The overall Index of Dysarthria (ID) is a sum of 45 items with the maximum score of 90 (the best function). This examination will be recorded and analysed by the beta version of the freely available Dysarthria Analyzer (Czech Technical University in Prague, available at http://dysan.cz/)
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The Mississippi Aphasia Screening Test at 3 weeks
A brief, repeatable screening measure for individuals with severely impaired communication/language skills. The sum of subtests 1-3 and 8-9 scores forms the MAST-E (range 0-50), while the subtests 4-7 form the MAST-R (range 0-50), and the sum of all subtests forms the MAST-T (range 0-100). Higher score, better function.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Image Naming Test at 3 weeks
a test of confrontational naming of nouns and verbs. Words are selected based on success, frequency of occurrence, age of adoption, length, and visual complexity. The maximum sum is 60 points (30 verbs and 30 nouns), the results can be assessed qualitatively according to the type of unexplained words (0 - 60). Higher score means better function.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Amnesia Light and Brief Assessment at 3 weeks
the original Czech and innovative test of how to easily (therefore in the name Light) and quickly examine the state of memory (therefore Amnesia Assessment) within two to three minutes (therefore Brief). The sum, called ALBA score, is derived from correctly recalled words of the sentence and correctly recalled gestures together (W2 + G2: 0-12). Higher score means better function.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Naming Pictures and Their Equipment at 3 weeks
an original Czech and short test, the purpose of which is to quickly check simultaneously written speech, long-term semantic and short-term visual memory. The title describes the main content of testing and the abbreviation POBAV (Naming Pictures and Their Equipment) was created from the key letters. The task of the examinee is to write the names of 20 pictures in one word and at the same time remember them. Participant is then asked to rewrite the names of the pictures he remembers (0 - 20). Higher score means better function.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Neuro - Quality of Life depression at 3 weeks
a self-report of health-related quality of life in domain concerning depression, The T-score rescales the raw sum score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean, while a person who has T-score of 60 is one standard deviation better (healthier) than the general population.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The Montreal Cognitive Assessment at 3 weeks
an assesment for detecting cognitive impairment ranged between 0 and 30 points. The more the better.
Measured: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 May 2022
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Double Blinded Controlled Trial with a longitudinal design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Thomayer University Hospital, Academy of Science Czech Republic, Ministry of Health, Czech Republic, Vascular surgery, University hospital Královské Vinohrady, Prague
- Responsible party
- Principal investigator, Kamila Řasová, Charles University, Czech Republic
- Investigators
- Kamila Řasová, Dr., Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323916
- Sponsor's protocol ID
- 12021
- Acronym
- COMIRESTROKE
- Status last verified
- Aug 2024
- First submitted
- 22 Oct 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan, Informed Consent Form are shared as attachment of this registration. Clinical Study Report and Analytic Code will be shared when data will be collected.
Publications
K R, P M, M V, B M, J H, D H, D I, L L, R V, J Z, J B, V M, T P. Improvements in upper extremity isometric muscle strength, dexterity, and self-care independence during the sub-acute phase of stroke recovery: an observational study on the effects of intensive comprehensive rehabilitation. Front Neurol. 2024 Oct 23;15:1442120. doi: 10.3389/fneur.2024.1442120. eCollection 2024.
PubMed 39507626Rasova 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.
PubMed 36388199
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05323916
- Acronym / sponsor ID
- COMIRESTROKE / 12021
- Conditions
- Stroke, Rehabilitation, Physical Therapy Modalities
- Keywords
- Technology, Goals, Neuroproprioceptive "facilitation and inhibition"
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Thomayer University Hospital, Academy of Science Czech Republic, Ministry of Health, Czech Republic, Vascular surgery, University hospital Královské Vinohrady, Prague
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomised Double Blinded Controlled Trial with a longitudinal design
| Arm | Type | Receives |
|---|---|---|
| Neuroproprioceptive "facilitation, inhibition" | Active comparator | Behavioral: Neuroproprioceptive "facilitation, inhibition"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. |
| Technology based physical therapy | Active comparator | Behavioral: Technology based physical therapyAccording 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. |
| Effectively managed rehabilitation implementing the recommendations of the World Health Organization | Experimental | Behavioral: Effectively managed rehabilitation implementing the recommendations of the World Health OrganizationThe 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. |
| Control group | Placebo comparator | Behavioral: Standard careParticipants will undergo standard care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroproprioceptive "facilitation, inhibition"Participants will undergo a standard comprehensive intensive rehabilitation program three hours a day for three weeks and moreover one hour a day of neuroproprioceptive "facilitation, inhibition" physical therapy. | Behavioural | Neuroproprioceptive "facilitation, inhibition" |
| Technology based physical therapyParticipants will undergo a standard comprehensive intensive rehabilitation program three hours a day for three weeks and moreover one hour a day of technology based physical therapy. | Behavioural | Technology based physical therapy |
| Effectively managed rehabilitation implementing the recommendations of the World Health OrganizationParticipants will undergo a four hour a day for three weeks of effectively managed comprehensive intensive rehabilitation implementing the recommendations of the World Health Organization. | Behavioural | Effectively managed rehabilitation implementing the recommendations of the World Health Organization |
| Standard careParticipants will undergo standardly provided care including face to face physiotherapy (bed mobility, transfers, gait, therapeutic exercises, positioning, education). | Behavioural | Control group |
Primary outcome
Change from Baseline Patient-reported Outcomes Measurement Information System - Global Health at 3 weeks, 3 and 12 months
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up assessments (3 and 12 months after the admission respectively)
a 10 item scale that assesses an individual's physical, mental, and social health where a standardized score with a mean of 50 and a standard deviation of 10, so a person with a T-score of 40 is one SD below the mean.
Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 3 weeks, 3 and 12 months
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).
the 36-item questionnaire, higher score means higher disability
Change from Baseline Goal Attainment scale at 3 weeks, 3 and 12 months
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).
Each goal is rated on 5-point scale (-2 much less than expected, 0 achieved the expected level, 2 much more than expected). Higher score means a better outcome.
19 secondary outcomes
Change from Baseline Jamar Hydraulic Hand Dynamometer at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline a power of the signal in band from frequency 1 to 2 at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline a frequency for which the smoothed power spectral density is maximal at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Nine Hole Peg Test at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Action Research Arm Test at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Motor Activity Log at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Timed Up And Go at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Berg Balance Scale at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The 10 Metre Walk Test at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The 6 Minute Walk Test at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Functional Independence Measure at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The Gugging Swallowing Screen at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The 3F Test - Dysarthric Profile at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The Mississippi Aphasia Screening Test at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Image Naming Test at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Amnesia Light and Brief Assessment at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Naming Pictures and Their Equipment at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline Neuro - Quality of Life depression at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Change from Baseline The Montreal Cognitive Assessment at 3 weeks
Time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 39507626K R, P M, M V, B M, J H, D H, D I, L L, R V, J Z, J B, V M, T P. Improvements in upper extremity isometric muscle strength, dexterity, and self-care independence during the sub-acute phase of stroke recovery: an observational study on the effects of intensive comprehensive rehabilitation. Front Neurol. 2024 Oct 23;15:1442120. doi: 10.3389/fneur.2024.1442120. eCollection 2024.
- Derived from this study: PubMed 36388199Rasova 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.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan, Informed Consent Form are shared as attachment of this registration. Clinical Study Report and Analytic Code will be shared when data will be collected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamila Řasová, Dr. principal investigator
Charles University, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroproprioceptive "facilitation, inhibition", Technology based physical therapy and Effectively managed rehabilitation implementing the recommendations of the World Health Organization in people with Stroke and Rehabilitation, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamila Řasová, Dr. (+420604511416, kamila.rasova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Patient-reported Outcomes Measurement Information System - Global Health at 3 weeks, 3 and 12 months (time frame: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up assessments (3 and 12 months after the admission respectively)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323916, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.