Digital Interactive Technologies in Rehabilitation of Post-sroke Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05214521
Study type	Interventional
Source	Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Contact	Liudmila V Petrova, PhD
Phone	+79163940742
Email	ludmila.v.petrova@yandex.ru
Status	Recruiting
Phase	N/A
Start date	January 11, 2021
Completion date	December 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Digital Interactive Technologies in Rehabilitation of Post-sroke Patients With Impaired Fine Function of the Hand

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms