Multimodal Correction of Post-stroke Motor and Cognitive Impairments (NCT05391919) | Clinical Trial Compass
CompletedNot Applicable
Multimodal Correction of Post-stroke Motor and Cognitive Impairments
Russia90 participantsStarted 2022-03-17
Plain-language 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 limb movements and cognitive functions in patients with ischemic stroke (IS) in different recovery periods with rehabilitation risks control in outpatient clinic.
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic
Timeframe: Baseline, day 7, day 15 of MT and 6 weeks after completing training
2
Action Research Arm Test (ARAT) Scale dynamic
Timeframe: Baseline, day 7, day 15 of MT and 6 weeks after completing training
3
Change from Baseline in 10 Metre Walk Test
Timeframe: Baseline, day 7, day 15 of MT and 6 weeks after completing training
4
Change from Baseline in Tinetti test
Timeframe: Baseline, day 7, day 15 of MT and 6 weeks after completing training
5
Changes in cognitive status
Timeframe: Baseline, day 7, day 15 of MT and 6 weeks after completing training
6
Change from Baseline of Presence and severity of depression and anxiety
Timeframe: Baseline, day 7, day 15 of MT and 6 weeks after completing training
7
Restoration of CNS function
Trial details
NCT IDNCT05391919
SponsorMoscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
. 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.
. Epilepsy
. Unstable angina and/or heart attack in previous month.