Research on the Effectiveness of Neurorehabilitation After Stroke

Summary

This clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. The study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. The goal of this trial is to advance stroke rehabilitation by exploring the potential benefits of these cutting-edge technologies.

Key Research Questions:

Efficacy: Does the new simulator significantly improve arm function compared to standard rehabilitation techniques?

BCI Technology: Which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements?

VR Contribution: How does the integration of VR enhance rehabilitation outcomes?

Safety and Tolerability: What potential side effects or adverse events may arise from using the new simulator?

Participants who have suffered a stroke will undergo a standard rehabilitation course, during which 10-12 sessions will take place using the innovative simulator: a robotic device moves a patient's paralyzed arm at the command of a non-invasive brain-computer interface to perform a game task resembling real-life activities, augmented by a virtual reality display.

Researchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.

Conditions

• Stroke
• Stroke Acute
• Stroke with Hemiparesis
• Stroke, Acute
• Stroke, Acute, Ischemic
• Stroke, Ischemic

Interventions

DEVICE

Neurorehabilitation simulator

The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.

PROCEDURE

Standard course

The participant receives a standard course of intervention as prescribed by the attending physician in accordance

Sponsors & Collaborators

• Samara State Medical University

  collaborator OTHER

• Samara Regional Clinical Hospital V.D. Seredavin

  collaborator OTHER

• Neurotechnika

  lead INDUSTRY

Principal Investigators

• Alexander Zakharov, Ph.D. · Samara State Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-27

Primary Completion

2025-07-31

Completion

2025-07-31

Countries

• Russia

Study Locations