Stroke RehabilitationNCT05944666
Substantiation and Standardization of the Multimodal Cognitive-motor Rehabilitation System for Afterstroke Patients
A study testing Multimodal technology (MT) and Conventional rehabilitation in people with Stroke Rehabilitation, run by Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine at 1 site in Russia.
Trial summary
The aim of the study is to develop and scientifically substantiate a standardized system of multimodal cognitive-motor rehabilitation and its differentiated application in patients with cerebral stroke, according to verified rehabilitation potential based on the patient's rehabilitation model for the stages of medical… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- Multimodal technology (MT) and Conventional rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteRussia
- Study dates
- 15 May 2023to 31 Dec 2025
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 45 to 70 years after a first-onset IS, acute (1-21 days), early (22 days- 6 months), late recovery (6-12 months) periods.
- Supratentorial IS according to MRI of the brain.
- The severity of UL and LL paresis ranged from a score of 4 to 2 according to the Medical Research Council Scale (MRCS)
- Spasticity of 3 points or less by the Modified Ashworth Scale (MAS)
- Cognitive function more than 20 points on the Montreal Cognitive Assessment (MoCA)
- Affective disorders score less than 11 on the Hospital Anxiety and Depression Scale (HADS)
- The patient's ability and willingness to comply with the requirements of this protocol.
Who cannot join
- Concomitant neurological diseases causing decreased muscle strength or increased muscle tone in the UL (e.g., cerebral palsy, brain injury).
- Clinically significant limitation of the passive movement amplitude in the joints of the investigated hand, pronounced contracture and deformities of the upper extremity.
- Use of other DIT, BFB techniques to restore impaired UL function within 30 days prior to the patient Inclusion Visit.
- Severe visual impairment, decreased visual acuity of less than 0.2 in the worst eye according to the Golovin-Sivtsev Table24.
- Sensory aphasia, gross motor aphasia.
- Recurrent stroke.
Show all 15Show fewer
- Epilepsy
- Unstable angina and/or heart attack in previous month.
- Uncontrolled arterial hypertension.
- Somatic diseases in decompensation stage.
- Thrombosis of deep and superficial veins of the lower extremities
- The presence of left-handedness in the patient according to the Edinburgh manual asymmetry questionnaire
- Alcohol abuse, medical marijuana use or soft drug abuse within the 12 months prior to the Inclusion Visit.
- Any medical condition, including mental disease or epilepsy that could affect the interpretation of study results, the study procedures or patient safety.
- 15 Pregnancy. 16. Lactation.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 3 and branch7
Moscow, 105120
Liudmila V Petrova, PhD, +79166728894, ludmila.v.petrova@yandex.ru
Elena V Kostenko, MD, +79057685856, ekostenko58@mail.ru
About this study
Official title: Standardization of the System of Multimodal Cognitive-motor Poststroke Rehabilitation, in Accordance With the Verification of Rehabilitation Potential, Rehabilitation Diagnosis and Patient Model, at the Stages of Medical Rehabilitation
The aim of the study is to develop and scientifically substantiate a standardized system of multimodal cognitive-motor rehabilitation and its differentiated application in patients with cerebral stroke, according to verified rehabilitation potential based on the patient's rehabilitation model for the stages of medical rehabilitation, including inpatient-replacement technologies
Read the detailed description
The object of the study The study will include 405 patients (men and women) with the diagnosis of ischemic stroke (IS) in the acute (0-21 day), early recovery (up to 6 months) and late recovery (6-12 months) periods with stato-locomotor disturbances, dysfunction (violation of neuromuscular movement control) of the upper limb (UL), lower limb (LL), mild or moderate cognitive impairment.
Patients will be randomly assigned to one of 6 experimental groups - 3 main groups of 70 patients each in the acute, early and late recovery period of IS and 3 comparison groups (each of 65 patients) in the acute, early and late recovery periods of IS. The patients in the main and comparison groups will be comparable in age, gender and symptoms.
Each participant of the study will be assigned an ordinal number. Patients of the main groups are planned to undergo a rehabilitation course with standardized multimodal correction, depending on the severity of functional and neuropsychological disturbances with the use of FBF-stabilometric training, cognitive-motor training with double and triple tasks in a virtual environment, functional individually programmed stimulation of antagonist muscles of the lower limb (FES), training of subject-manipulative activity for the restoration of fine hand movements on the glove simulator "SensoRehab"; when severe and moderate paresis of the upper limb, the neurointerface "Exokist-2" with EEG registration will be used.
The patients of comparison groups are planned to undergo a rehabilitation course with standart rehabilitation programms depending on the severity of functional and neuropsychological disturbances: kinesiotherapy, physical therapy, occupational therapy, massage.
The study is carried out at the inpatient stage, then patients are transferred to the outpatient stage of rehabilitation or controlled home self-rehabilitation using telemedicine technologies.
The mode of application of multimodal correction technology:
inpatient stage: 10 procedures every day (5 working days, 2 days the rest);the total duration of one procedure is 2-3 hours a day.
outpatient stage: 15 procedures, 2-3 times a week, the duration of the course is 5-8 weeks. The total duration of one procedure is 2-3 hours a day.
Multimodal correction technology will not be included in the rehabilitation program of patients in the comparison group.
- Conditions
- Stroke Rehabilitation
- Being tested
- Multimodal technology (MT), Conventional rehabilitation
- Keywords
- ischemic stroke rehabilitation, post-stroke dysfunction of the hand, cognitive disfunction, artificial intelligence, virtual reality, neurointerface, smart glove, biofeedback, cardiology risk control, lower limb medical rehabilitation, digital interactive technology, standartized rehabilitation technologies, verification of the rehabilitation potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal technology (MT)Procedure or surgery
Only fo the patients of the Main group. It will be different programms depending on severety of UL or LL paresis. Patients will receive a course of rehabilitation with multimodal correction using BFB-stabilometric training, cognitive-motor training with double and triple tasks once a day for the affected hand, virtual reality, functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, in moderate paresis of the upper limb, the neurointerface "Exokist-2" with EEG registration will be used. The program for IS patients includes 10 sessions in inpatient stage every day 15-30 min for the method, 15 sessions with the MT in outpatient stage: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.
Conventional rehabilitationProcedure or surgery
It will be different programms depending on severety of UL or LL paresis. Conventional rehabilitation (CR) includes physiotherapy, kinesiotherapy, occupational therapy. The program for IS patients consists of 10 sessions of every day trainings for inpatients stage, 15 sessions with the CR for outpatient stage: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Medical rehabilitation (MR) in acute period of IS-inpatient stage | Experimental | Devices Patients in acute period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. Receives: Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation |
| MR in early recovery period of IS- inpatient stage | Experimental | Devices Patients in the early recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. Receives: Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation |
| MR in late recovery period of IS-inpatient stage | Experimental | Devices Patients in the late recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. Receives: Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation |
| MR in early recovery period of IS - outpatient stage | Experimental | Devices Patients in the early recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. Receives: Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation |
| MR in late recovery period of IS - outpatient stage | Experimental | Devices Patients in the late recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. Receives: Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICF motor and sensitive domains dynamic
Changes in the severity of dysfunctions by at least 1 determinant point of at least 1 of the selected ICF domains characterizing motor stereotype, balance at rest and when walking, fine motor skills of the upper limb, sensory disorders, pain syndrome
Measured: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Secondary outcomes (6)
ICF cognitive and emotional domains dynamic
Changes in the severity of disorders by at least 1 determinant point of at least 1 of the selected ICF domains characterizing neuropsychological disorders (cognitive, emotional) and personal factors.
Measured: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes in level of impairment or dependence in daily life
Changes of the degree of functional independence according to the Bartel index
Measured: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes in Rankin scale
Changes of the degree of disability, independence and rehabilitation outcomes according to the Rankin scale
Measured: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Canges in Rehabilitation routing scale (RRS)
Changes of the degree of disability, independence and rehabilitation outcomes according to the RRS
Measured: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes of Life quality assessment
Improving the quality of life according to the European Quality of Life Questionnaire EuroQol EQ-5D-5L
Measured: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes of SF-36 questionnaire
Changes of the quality of life scores according to the SF36
Measured: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start15 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RehabilitationStudies 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
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadezda Lyamina, Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944666
- Sponsor's protocol ID
- 3/15.05.2023
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of the System of Multimodal Cognitive-motor Poststroke Rehabilitation, in Accordance With the Verification of Rehabilitation Potential, Rehabilitation Diagnosis and Patient Model, at the Stages of Medical Rehabilitation
- ClinicalTrials.gov ID
- NCT05944666
- Acronym / sponsor ID
- 3/15.05.2023
- Conditions
- Stroke Rehabilitation
- Keywords
- ischemic stroke rehabilitation, post-stroke dysfunction of the hand, cognitive disfunction, artificial intelligence, virtual reality, neurointerface, smart glove, biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports MedicineUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jul 2023 (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.
The aim of the study is to develop and scientifically substantiate a standardized system of multimodal cognitive-motor rehabilitation and its differentiated application in patients with cerebral stroke, according to verified rehabilitation potential based on the patient's rehabilitation model for the stages of medical rehabilitation, including inpatient-replacement technologies
Detailed description
The object of the study The study will include 405 patients (men and women) with the diagnosis of ischemic stroke (IS) in the acute (0-21 day), early recovery (up to 6 months) and late recovery (6-12 months) periods with stato-locomotor disturbances, dysfunction (violation of neuromuscular movement control) of the upper limb (UL), lower limb (LL), mild or moderate cognitive impairment.
Patients will be randomly assigned to one of 6 experimental groups - 3 main groups of 70 patients each in the acute, early and late recovery period of IS and 3 comparison groups (each of 65 patients) in the acute, early and late recovery periods of IS. The patients in the main and comparison groups will be comparable in age, gender and symptoms.
Each participant of the study will be assigned an ordinal number. Patients of the main groups are planned to undergo a rehabilitation course with standardized multimodal correction, depending on the severity of functional and neuropsychological disturbances with the use of FBF-stabilometric training, cognitive-motor training with double and triple tasks in a virtual environment, functional individually programmed stimulation of antagonist muscles of the lower limb (FES), training of subject-manipulative activity for the restoration of fine hand movements on the glove simulator "SensoRehab"; when severe and moderate paresis of the upper limb, the neurointerface "Exokist-2" with EEG registration will be used.
The patients of comparison groups are planned to undergo a rehabilitation course with standart rehabilitation programms depending on the severity of functional and neuropsychological disturbances: kinesiotherapy, physical therapy, occupational therapy, massage.
The study is carried out at the inpatient stage, then patients are transferred to the outpatient stage of rehabilitation or controlled home self-rehabilitation using telemedicine technologies.
The mode of application of multimodal correction technology:
inpatient stage: 10 procedures every day (5 working days, 2 days the rest);the total duration of one procedure is 2-3 hours a day.
outpatient stage: 15 procedures, 2-3 times a week, the duration of the course is 5-8 weeks. The total duration of one procedure is 2-3 hours a day.
Multimodal correction technology will not be included in the rehabilitation program of patients in the comparison group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Medical rehabilitation (MR) in acute period of IS-inpatient stage | Experimental | Procedure: Multimodal technology (MT), Procedure: Conventional rehabilitationDevices Patients in acute period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. |
| MR in early recovery period of IS- inpatient stage | Experimental | Procedure: Multimodal technology (MT), Procedure: Conventional rehabilitationDevices Patients in the early recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. |
| MR in late recovery period of IS-inpatient stage | Experimental | Procedure: Multimodal technology (MT), Procedure: Conventional rehabilitationDevices Patients in the late recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. |
| MR in early recovery period of IS - outpatient stage | Experimental | Procedure: Multimodal technology (MT), Procedure: Conventional rehabilitationDevices Patients in the early recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. |
| MR in late recovery period of IS - outpatient stage | Experimental | Procedure: Multimodal technology (MT), Procedure: Conventional rehabilitationDevices Patients in the late recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women aged 45 to 70 years after a first-onset IS, acute (1-21 days), early (22 days- 6 months), late recovery (6-12 months) periods.
- Supratentorial IS according to MRI of the brain.
- The severity of UL and LL paresis ranged from a score of 4 to 2 according to the Medical Research Council Scale (MRCS)
- Spasticity of 3 points or less by the Modified Ashworth Scale (MAS)
- Cognitive function more than 20 points on the Montreal Cognitive Assessment (MoCA)
Key exclusion criteria (15 listed)
- Concomitant neurological diseases causing decreased muscle strength or increased muscle tone in the UL (e.g., cerebral palsy, brain injury).
- Clinically significant limitation of the passive movement amplitude in the joints of the investigated hand, pronounced contracture and deformities of the upper extremity.
- Use of other DIT, BFB techniques to restore impaired UL function within 30 days prior to the patient Inclusion Visit.
- Severe visual impairment, decreased visual acuity of less than 0.2 in the worst eye according to the Golovin-Sivtsev Table24.
- Sensory aphasia, gross motor aphasia.
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 |
|---|---|---|
| Multimodal technology (MT)Only fo the patients of the Main group. It will be different programms depending on severety of UL or LL paresis. Patients will receive a course of rehabilitation with multimodal correction using BFB-stabilometric training, cognitive-motor training with double and triple tasks once a day for the affected hand, virtual reality, functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, in moderate paresis of the upper limb, the neurointerface "Exokist-2" with EEG registration will be used. The program for IS patients includes 10 sessions in inpatient stage every day 15-30 min for the method, 15 sessions with the MT in outpatient stage: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours. | Procedure or surgery | MR in early recovery period of IS - outpatient stage, MR in early recovery period of IS- inpatient stage, MR in late recovery period of IS - outpatient stage, MR in late recovery period of IS-inpatient stage, Medical rehabilitation (MR) in acute period of IS-inpatient stage |
| Conventional rehabilitationIt will be different programms depending on severety of UL or LL paresis. Conventional rehabilitation (CR) includes physiotherapy, kinesiotherapy, occupational therapy. The program for IS patients consists of 10 sessions of every day trainings for inpatients stage, 15 sessions with the CR for outpatient stage: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours. | Procedure or surgery | MR in early recovery period of IS - outpatient stage, MR in early recovery period of IS- inpatient stage, MR in late recovery period of IS - outpatient stage, MR in late recovery period of IS-inpatient stage, Medical rehabilitation (MR) in acute period of IS-inpatient stage |
Primary outcome
ICF motor and sensitive domains dynamic
Time frame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes in the severity of dysfunctions by at least 1 determinant point of at least 1 of the selected ICF domains characterizing motor stereotype, balance at rest and when walking, fine motor skills of the upper limb, sensory disorders, pain syndrome
6 secondary outcomes
ICF cognitive and emotional domains dynamic
Time frame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes in level of impairment or dependence in daily life
Time frame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes in Rankin scale
Time frame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Canges in Rehabilitation routing scale (RRS)
Time frame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes of Life quality assessment
Time frame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes of SF-36 questionnaire
Time frame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal technology (MT) and Conventional rehabilitation in people with Stroke Rehabilitation, run by Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine at 1 site in Russia.
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 7 inclusion and 15 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 13 Jul 2023. 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 Russia. 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. 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 Elena V Kostenko, MD (+79057685856, ekostenko58@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICF motor and sensitive domains dynamic (time frame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2023.