Stroke RehabilitationNCT05391919
Multimodal Correction of Post-stroke Motor and Cognitive Impairments
A study testing Multimodal technology (MT) and Conventional rehabilitation (CR) 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 the development and scientific substantiation of the effectiveness and safety of multimodal rehabilitation technology using innovative digital technologies, biofeedback (BFB), virtual reality (VR), neurointerface for the restoration of stato-locomotor disorders, neuromuscular control of upper… 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 (CR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteRussia
- Study dates
- 17 Mar 2022to 31 May 2023
- 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, early (1-6 months), late recovery (6-12 months) periods.
- Supratentorial IS according to MRI of the brain.
- The severity of UL paresis ranged from a score of 4 to 3 according to the Medical Research Council Scale (MRCS).20
- Spasticity of 2 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.
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- 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
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
Moscow, 105120
About this study
Official title: Multimodal Correction of Post-stroke Motor and Cognitive Impairments With the Integrated Use of Innovative Digital Technologies, Biofeedback, Virtual Reality, a Neurointerface With Cardiovascular Risks Monitoring in an Outpatient Clinic
The aim of the study is the development and scientific substantiation of the effectiveness and safety of multimodal rehabilitation technology using innovative digital technologies, biofeedback (BFB), virtual reality (VR), neurointerface for the restoration of stato-locomotor disorders, neuromuscular control of upper limb movements and cognitive functions in patients with ischemic stroke (IS) in different recovery periods with rehabilitation risks control in outpatient clinic.
Read the detailed description
The object of the study The study will include 90 patients (men and women) with the diagnosis of ischemic stroke (IS) in the 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), mild or moderate cognitive impairment.
Patients will be randomly assigned to one of three experimental groups - 2 main groups in the early (30 patients) and in the late recovery period (30 patients) of IS and 1 comparison group (30 patients) in the early and late recovery periods of IS.
Each participant of the study will be assigned an ordinal number. Patients of the 1st and 2nd main groups are planned to undergo a rehabilitation course with 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-3" with EEG registration will be used.
The mode of application of multimodal correction technology: 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 (CR)
- Keywords
- ischemic stroke rehabilitation, post-stroke dysfunction of the hand, cognitive disfunction, artificial intelligence, virtual reality, neurointerface, smart glove, biofeedback, cardiology risk control, upper limb medical rehabilitation, digital interactive technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal technology (MT)Other
Patients will receive a course of rehabilitation with multimodal correction using BOS-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 "SensoRehab", in moderate paresis of the upper limb, the neurointerface "Exokist-3" with EEG registration will be used. The program for IS patients includes 15 sessions with the MT: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.
Conventional rehabilitation (CR)Other
The patients will recieve Conventional rehabilitation technology (physiotherapy, kinesiotherapy, occupational therapy. The program for IS patients includes 15 sessions with the CR: 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 |
|---|---|---|
| MT in early recovery period of IS | Experimental | Patients in early recovery period of IS receive a course of rehabilitation with multimodal correction using 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 "SensoRehab", if moderate paresis of the upper limb - the neurointerface "Exokist-3" with EEG registration. Receives: Other: Multimodal technology (MT) |
| MT in late recovery period of IS | Experimental | Patients in late recovery period of IS receive a course of rehabilitation with multimodal correction using 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 "SensoRehab", if moderate paresis of the upper limb - the neurointerface "Exokist-3" with EEG registration. Receives: Other: Multimodal technology (MT) |
| No MT Intervention: Conventional IS rehabilitation | Active comparator | Patients in early and late recovery period of IS recieve conventional complex rehabilitation: kinesiotherapy, physiotherapy, occupational therapy. Receives: Other: Conventional rehabilitation (CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic
The FMA UE Scale comprises 33 items, each scored on a scale of0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. It is free, requires only household items fortesting, and takes up to 30 minutes to administer. Changes in sections A-D of the FMA-UE Scale by 7 points or more are considered as efficacy.
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Action Research Arm Test (ARAT) Scale dynamic
The Action Research Arm Test (ARAT) is a 19 item observational measures. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Changes in the total ARAT Scale score by 4 points or more more are considered as efficacy.
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Change from Baseline in 10 Metre Walk Test
The individual walks without assistance for 10 meters, with the time measured for the intermediate 6 meters to allow for acceleration and deceleration. The total time taken to ambulate 6 meters is recorded Timing starts when the toes pass the 2-meter mark Timing stops when the toes pass the 8-meter mark
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Change from Baseline in Tinetti test
The Tinetti-test is used to assess the gait and balance, perception of balance and stability during activities of daily living.The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Changes in cognitive status
Assesment by the Montreal Cognitive Assessment scale (МоСА). MoCA is scored out of 30. A cut-off score of 26 signifies mild cognitive impairment.
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Change from Baseline of Presence and severity of depression and anxiety
The Hospital Anxiety and Depression Scale (HADS). Changes in HADS anxiety and depression scores.The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.8-10 - points subclinically expressed anxiety / depression 11 points and above - clinically expressed anxiety / depression.
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Restoration of CNS function
Concentration of human brain neurotrophic factor (BDNF) in the blood serum of patients by solid-phase enzyme immunoassay
Measured: Baseline, day 15 of MT
Secondary outcomes (7)
Percentage of correctly performed tasks
percentage of correctly performed tasks while training
Measured: Baseline, day 7, day 15
change in the paresis degree ин the 6-point Medical Research Council Scale for assessing muscle strength: MRCS
The 6-point Medical Research Council Scale for assessing. The patient's effort is graded on a scale of 0-5. Grade 5: Muscle contracts normally against full resistance.Grade 0: No movement is observed. Grade 4 - light paresis. Grade 3 - moderate paresis. Grades 1-2 - severe paresis. The best result is 5, deterioration - a decrease in the indicator on the scale
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Changes in spasticity severity
Modified Ashworth Scale: MAS (0 to 4 points). Scoring: 0 No increase in tone (the best point); 4 limb rigid in flexion or extension (the worse outcome)
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Changes in level of impairment or dependence in daily life
Barthel Index.The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Changes of Life quality assessment
European Quality of Life Questionnaire EuroQol EQ-5D-5L (version 1.0, 2011 in combination with the visual analogue scale). Health State: The respondent classifies his or her prevailing state of health by selecting one of three different levels of problem severity within each of five health domains. The levels are none, moderate and severe/extreme (coded 1 through 3, respectively), whilst the domains are mobility, capacity for self-care, conduct of usual activities, pain/discomfort and anxiety/depression, ordered as such.
Evaluation: The respondent then evaluates his or her health using a visual analogue scale (VAS). This is a vertical, calibrated, line, bounded at 0 ("worst imaginable health state") and at 100 ("best imaginable health state"). Respondents indicate where they perceive their present state of health to lie, relative to these anchors.
Measured: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Canges in Rehabilitation routing scale.
The rehabilitation Routing Scale (SRM), developed by the Ministry of Health of Russia has six points:
- The absence of significant disorders of vital activity, despite the existing symptoms of the disease
- Slight restriction of vital activity
- Restriction of vital activity, moderate in its severity
- Pronounced restriction of vital activity
- Gross violation of vital processes
- Violation of vital activity of extreme severity An improvement is considered to be a decrease in the score on the scale.
Measured: Baseline, day 15 of MT and 6 weeks after completing training
Changes by international scale of functioning, disability and health (ISF)
A generic qualifier scale can be used to record the extent of the problem for each identified impairment, activity limitation and participation restriction. Environmental factors can also be qualified as either barriers or facilitators. Improvement - reduction of the qualifier's score in the selected domain
Measured: Baseline, day 15 of MT and 6 weeks after completing training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start17 Mar 2022
- Primary completion31 May 2023
- Study completion31 May 2023
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
- Open lable randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Moscow Government
- Responsible party
- Sponsor
- Investigators
- Elena V Kostenko, PhD, D. Sс (Medicine), Study director, Moscow scientific and practical center of medical rehabilitation, restorative and sports medicine of the Department of health of the city of Moscow, branch 7;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391919
- Sponsor's protocol ID
- 1/17.03.2022
- Status last verified
- Sep 2023
- First submitted
- 18 May 2022
- Last updated
- 14 Sep 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Correction of Post-stroke Motor and Cognitive Impairments With the Integrated Use of Innovative Digital Technologies, Biofeedback, Virtual Reality, a Neurointerface With Cardiovascular Risks Monitoring in an Outpatient Clinic
- ClinicalTrials.gov ID
- NCT05391919
- Acronym / sponsor ID
- 1/17.03.2022
- 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
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports MedicineUniversity, hospital or other
- Collaborators
- Moscow Government
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 26 May 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.
The aim of the study is the development and scientific substantiation of the effectiveness and safety of multimodal rehabilitation technology using innovative digital technologies, biofeedback (BFB), virtual reality (VR), neurointerface for the restoration of stato-locomotor disorders, neuromuscular control of upper limb movements and cognitive functions in patients with ischemic stroke (IS) in different recovery periods with rehabilitation risks control in outpatient clinic.
Detailed description
The object of the study The study will include 90 patients (men and women) with the diagnosis of ischemic stroke (IS) in the 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), mild or moderate cognitive impairment.
Patients will be randomly assigned to one of three experimental groups - 2 main groups in the early (30 patients) and in the late recovery period (30 patients) of IS and 1 comparison group (30 patients) in the early and late recovery periods of IS.
Each participant of the study will be assigned an ordinal number. Patients of the 1st and 2nd main groups are planned to undergo a rehabilitation course with 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-3" with EEG registration will be used.
The mode of application of multimodal correction technology: 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
- Single blind (participant)
- Number of arms
- 3
- Model description
- Open lable randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| MT in early recovery period of IS | Experimental | Other: Multimodal technology (MT)Patients in early recovery period of IS receive a course of rehabilitation with multimodal correction using 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 "SensoRehab", if moderate paresis of the upper limb - the neurointerface "Exokist-3" with EEG registration. |
| MT in late recovery period of IS | Experimental | Other: Multimodal technology (MT)Patients in late recovery period of IS receive a course of rehabilitation with multimodal correction using 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 "SensoRehab", if moderate paresis of the upper limb - the neurointerface "Exokist-3" with EEG registration. |
| No MT Intervention: Conventional IS rehabilitation | Active comparator | Other: Conventional rehabilitation (CR)Patients in early and late recovery period of IS recieve conventional complex rehabilitation: kinesiotherapy, physiotherapy, occupational therapy. |
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, early (1-6 months), late recovery (6-12 months) periods.
- Supratentorial IS according to MRI of the brain.
- The severity of UL paresis ranged from a score of 4 to 3 according to the Medical Research Council Scale (MRCS).20
- Spasticity of 2 points or less by the Modified Ashworth Scale (MAS)
- Cognitive function more than 20 points on the Montreal Cognitive Assessment (MoCA)
Key exclusion criteria (16 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)Patients will receive a course of rehabilitation with multimodal correction using BOS-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 "SensoRehab", in moderate paresis of the upper limb, the neurointerface "Exokist-3" with EEG registration will be used. The program for IS patients includes 15 sessions with the MT: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours. | Other | MT in early recovery period of IS, MT in late recovery period of IS |
| Conventional rehabilitation (CR)The patients will recieve Conventional rehabilitation technology (physiotherapy, kinesiotherapy, occupational therapy. The program for IS patients includes 15 sessions with the CR: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours. | Other | No MT Intervention: Conventional IS rehabilitation |
Primary outcome
Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
The FMA UE Scale comprises 33 items, each scored on a scale of0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. It is free, requires only household items fortesting, and takes up to 30 minutes to administer. Changes in sections A-D of the FMA-UE Scale by 7 points or more are considered as efficacy.
Action Research Arm Test (ARAT) Scale dynamic
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
The Action Research Arm Test (ARAT) is a 19 item observational measures. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Changes in the total ARAT Scale score by 4 points or more more are considered as efficacy.
Change from Baseline in 10 Metre Walk Test
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
The individual walks without assistance for 10 meters, with the time measured for the intermediate 6 meters to allow for acceleration and deceleration. The total time taken to ambulate 6 meters is recorded Timing starts when the toes pass the 2-meter mark Timing stops when the toes pass the 8-meter mark
Change from Baseline in Tinetti test
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
The Tinetti-test is used to assess the gait and balance, perception of balance and stability during activities of daily living.The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
Changes in cognitive status
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Assesment by the Montreal Cognitive Assessment scale (МоСА). MoCA is scored out of 30. A cut-off score of 26 signifies mild cognitive impairment.
Change from Baseline of Presence and severity of depression and anxiety
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
The Hospital Anxiety and Depression Scale (HADS). Changes in HADS anxiety and depression scores.The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.8-10 - points subclinically expressed anxiety / depression 11 points and above - clinically expressed anxiety / depression.
Restoration of CNS function
Time frame: Baseline, day 15 of MT
Concentration of human brain neurotrophic factor (BDNF) in the blood serum of patients by solid-phase enzyme immunoassay
7 secondary outcomes
Percentage of correctly performed tasks
Time frame: Baseline, day 7, day 15
change in the paresis degree ин the 6-point Medical Research Council Scale for assessing muscle strength: MRCS
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Changes in spasticity severity
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Changes in level of impairment or dependence in daily life
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Changes of Life quality assessment
Time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Canges in Rehabilitation routing scale.
Time frame: Baseline, day 15 of MT and 6 weeks after completing training
Changes by international scale of functioning, disability and health (ISF)
Time frame: Baseline, day 15 of MT and 6 weeks after completing training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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.
Elena V Kostenko, PhD, D. Sс (Medicine) study director
Moscow scientific and practical center of medical rehabilitation, restorative and sports medicine of the Department of health of the city of Moscow, branch 7;
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 (CR) 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 16 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: finished, as of the sponsor's last update on 14 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic (time frame: Baseline, day 7, day 15 of MT and 6 weeks after completing training). The study lists 7 primary outcomes in all. 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 14 Sep 2023.