Multimodal Correction of Post-stroke Motor and Cognitive Impairments

NCT05391919 | Completed

• 1 other identifier: 1/17.03.2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke Rehabilitation

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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

  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.

  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.

  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.

  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

  Baseline, day 15 of MT

Secondary Outcomes (7)

• Percentage of correctly performed tasks

  Baseline, day 7, day 15

• change in the paresis degree ин the 6-point Medical Research Council Scale for assessing muscle strength: MRCS

  Baseline, day 7, day 15 of MT and 6 weeks after completing training

• Changes in spasticity severity

  Baseline, day 7, day 15 of MT and 6 weeks after completing training

• Changes in level of impairment or dependence in daily life

  Baseline, day 7, day 15 of MT and 6 weeks after completing training

• Changes of Life quality assessment

  Baseline, day 7, day 15 of MT and 6 weeks after completing training

Other Outcomes (2)

• Number of participants with abnormal electrocardiogram (ECG) readings

  Baseline, day 1-15 of MT

• Number of participants with abnormal electroencephalogram (EEG) readings

  Baseline, day 15 of MT

Study Arms (3)

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.

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.

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.

Other: Conventional rehabilitation (CR)

Interventions

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.

MT in early recovery period of IS; MT in late recovery period of IS

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.

No MT Intervention: Conventional IS rehabilitation

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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
• Any medical condition, including mental disease or epilepsy that could affect the interpretation of study results, the study procedures or patient safety.
• Pregnancy. 16. Lactation.

Sponsors & Collaborators

• Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine: lead
• Moscow Government: collaborator

Study Sites (1)

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7

Moscow, 105120, Russia

Location

Study Officials

• Elena V Kostenko, PhD, D. Sс (Medicine)

  Moscow scientific and practical center of medical rehabilitation, restorative and sports medicine of the Department of health of the city of Moscow, branch 7;

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open lable randomized clinical trial

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 26, 2022
• Study Start: March 17, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

RU (1)