Clinical trial NCT05214521: Digital Interactive Technologies in Rehabilitation of Post-sroke Patients With Impaired Fine Function of the Hand
Official title: Investigation of the Effectiveness and Safety of Rehabilitation of Patients With Impaired Fine Function of the Hand Due to a Stroke Using "Glove Simulator "SensoRehab" Based on Digital Interactive Technologies With Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: post-stroke dysfunction of the hand
upper limb medical rehabilitation
digital interactive technology
artificial intelligence
ischemic stroke rehabilitation
Lead sponsor: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: an open-label observational trial
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the efficacy and safety of digital interactive technology with artificial intelligence and biofeedback Smart glove "SensoRehab" for restoration of in-hand manipulation in patients with ischemic stroke in the early and late recovery periods.

Detailed description: The study is an open-label observational trial. Brain stroke (BS) is one of the main causes of upper limb (UL) dysfunction and limitations of daily human activity.The fine use of the hand imparement is often combined with speech, cognitive and emotional disturbances, which is due to the anatomical proximity and close functional relationships of the corresponding areas in the cerebral cortex.

The objective of the present study will be to evaluate the effectiveness and safety of the digital interactive technology (DIT) with artificial intelligence and biofeedback Smart glove "SensoRehab" (SGSR) for restoration of in-hand manipulation in patients with ischemic stroke in the early and late recovery period.The SGSR technique involves neurosensory training and retraining to improve the fine use of the hand and arm, and the patient's cognitive and emotional state.

30 patients will be include to the study. After a basic assessment of hand motor function and game training, each patient undergoes sessions on the SGSR system. The program for BS patients includes 10 sessions with the SGSR (15-30 minutes once a day for the affected hand, 2 weeks).

The clinical outcomes will be obtained at the completion of treatment (2 weeks) and at 1 month after ompletion of the course of rehabilitation. The statistical analysis will follow the intention-to-treat principles.

The outcomes of interest are motor function state of the UL, pain intensity, cognitive functions, general physical and emotional status. An integral indicators are the assessment of the patient's quality of life and independence in everyday life activity.

Eligibility criteria: Inclusion Criteria:

1. Men or women aged 18 to 70 years after a first-onset IS, early (1-6 months), late recovery (6-12 months) periods.
2. Supratentorial IS according to MRI of the brain.
3. The severity of UL paresis ranged from a score of 4 to 3 according to the Medical Research Council Scale (MRCS).20
4. Spasticity of 2 points or less by the Modified Ashworth Scale (MAS)
5. Cognitive function more than 20 points on the Montreal Cognitive Assessment (MoCA)
6. Affective disorders score less than 11 on the Hospital Anxiety and Depression Scale (HADS)
7. 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. Unstable angina and/or heart attack in previous month.
8. Uncontrolled arterial hypertension.
9. Somatic diseases in decompensation stage.
10. Alcohol abuse, medical marijuana use or soft drug abuse within the 12 months prior to the Inclusion Visit.
11. Any medical condition, including mental disease or epilepsy that could affect the interpretation of study results, the study procedures or patient safety.
12. Pregnancy.
13. Lactation.

Primary outcomes:
measure: Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic
timeFrame: Baseline, end of the 2-nd week
measure: Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic
timeFrame: Baseline, 1-month after completing training
measure: Action Research Arm Test (ARAT) Scale dynamic
timeFrame: Baseline, end of the 2-nd week
measure: Action Research Arm Test (ARAT) Scale dynamic
timeFrame: Baseline, 1-month after completing training
Secondary outcomes:
measure: percentage of correctly performed tasks
timeFrame: Baseline, end of the 2-nd week
measure: change in the paresis degree The 6-point Medical Research Council Scale for assessing muscle strength: MRCS
timeFrame: Baseline, end of the 2-nd week and 1-month after completing training
measure: changes in spasticity severity
timeFrame: Baseline, end of the 2-nd week and 1-month after completing training
measure: changes in level of impairment or dependence in daily life
timeFrame: Baseline, end of the 2-nd week and 1-month after completing training
measure: сhanges in cognitive status
timeFrame: Baseline, end of the 2-nd week and 1-month after completing training
measure: Presence and severity of depression
timeFrame: Baseline, end of the 2-nd week and 1-month after completing training
measure: Life quality assessment
timeFrame: Baseline, end of the 2-nd week and 1-month after completing training
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
Study officials:
affiliation: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
name: Elena V Kostenko, MD
role: PRINCIPAL_INVESTIGATOR
References: