Rehabilitation system for stroke patients
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
This study is testing a new rehabilitation program that combines mental and physical exercises in a virtual setting to see if it helps stroke patients recover better than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 405 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05944666 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and scientifically validate a standardized multimodal cognitive-motor rehabilitation system for patients recovering from ischemic stroke. It will involve 405 participants who will be randomly assigned to different groups based on their recovery stage, with interventions including advanced training techniques in a virtual environment and functional stimulation of muscles. The goal is to tailor rehabilitation approaches according to individual patient needs and rehabilitation potential, enhancing recovery outcomes. The study will assess the effectiveness of these interventions compared to conventional rehabilitation methods.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 45 to 70 who have experienced a first-onset ischemic stroke and are in various recovery stages.
Not a fit: Patients with other neurological diseases or significant joint limitations may not benefit from this rehabilitation approach.
Why it matters
Potential benefit: If successful, this rehabilitation system could significantly improve recovery outcomes for stroke patients, enhancing their cognitive and motor functions.
How similar studies have performed: While similar multimodal rehabilitation approaches have shown promise, this specific system is novel and aims to standardize and substantiate its effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: 1. Concomitant neurological diseases causing decreased muscle strength or increased muscle tone in the UL (e.g., cerebral palsy, brain injury). 2. Clinically significant limitation of the passive movement amplitude in the joints of the investigated hand, pronounced contracture and deformities of the upper extremity. 3. Use of other DIT, BFB techniques to restore impaired UL function within 30 days prior to the patient Inclusion Visit. 4. Severe visual impairment, decreased visual acuity of less than 0.2 in the worst eye according to the Golovin-Sivtsev Table24. 5. Sensory aphasia, gross motor aphasia. 6. Recurrent stroke. 7. Epilepsy 8. Unstable angina and/or heart attack in previous month. 9. Uncontrolled arterial hypertension. 10. Somatic diseases in decompensation stage. 11. Thrombosis of deep and superficial veins of the lower extremities 12. The presence of left-handedness in the patient according to the Edinburgh manual asymmetry questionnaire 13. Alcohol abuse, medical marijuana use or soft drug abuse within the 12 months prior to the Inclusion Visit. 14. 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.
Where this trial is running
Moscow
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 3 and branch7 — Moscow, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Elena V Kostenko, MD
- Email: ekostenko58@mail.ru
- Phone: +79057685856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.