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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will receive rehabilitation program including sessions on the Smart glove "SensoRehab" (SGSR) system. The program for IS patients includes 10 sessions with the SGSR: 15-30 minutes once a day for the affected hand, 2 weeks.
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
Moscow, Russia
RECRUITINGFugl-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.
Time frame: Baseline, end of the 2-nd week
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.
Time frame: Baseline, 1-month 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.
Time frame: Baseline, end of the 2-nd week
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.
Time frame: Baseline, 1-month after completing training
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percentage of correctly performed tasks
percentage of correctly performed tasks while training
Time frame: Baseline, end of the 2-nd week
change in the paresis degree The 6-point Medical Research Council Scale for assessing muscle strength: MRCS
The 6-point Medical Research Council Scale for assessing
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
changes in spasticity severity
Modified Ashworth Scale: MAS (0 to 4 points)
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
changes in level of impairment or dependence in daily life
Barthel ADL Index
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
сhanges in cognitive status
Montreal Cognitive Assessment: МоСА
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
Presence and severity of depression
The Hospital Anxiety and Depression Scale: HADS. Changes in HADS anxiety and depression scores
Time frame: Baseline, end of the 2-nd week and 1-month after completing training
Life quality assessment
European Quality of Life Questionnaire EuroQol EQ-5D-5L (version 1.0, 2011 in combination with the visual analogue scale)
Time frame: Baseline, end of the 2-nd week and 1-month after completing training