Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06753006

Neurorehabilitation Using Robotics, Brain-Computer Interface, and Virtual Reality for Arm Weakness After Stroke in Early Recovery

Led by Neurotechnika · Updated on 2025-01-01

44

Participants Needed

1

Research Sites

44 weeks

Total Duration

On this page

Sponsors

N

Neurotechnika

Lead Sponsor

S

Samara State Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new neurorehabilitation technology designed to improve arm function in adults who have experienced a stroke. This study explores a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. The trial aims to determine how effective this combined approach is compared to standard rehabilitation techniques and to assess which BCI method and VR integration best support recovery. Safety and tolerability of the new simulator are also being monitored. Participants will undergo a standard rehabilitation program alongside 10 to 12 sessions using the neurorehabilitation simulator. During these sessions, the participant performs a mental task by imagining moving their arm. Successful mental commands cause the robotic device to move the paralyzed limb while the VR display presents a game-like activity resembling real-life tasks. This approach combines physical movement with brain and visual feedback in the early rehabilitation phase after stroke. Throughout the study, researchers will assess changes in arm function from enrollment to the end of treatment at 2 to 3 weeks using measures such as the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and the Action Research Arm Test (ARAT). Participants' adherence and response to the intervention will be closely monitored, with evaluations including neurological assessments and safety checks. The total study duration covers the early rehabilitation period within six months post-stroke.

CONDITIONS

Official Title

Research on the Effectiveness of Neurorehabilitation After Stroke

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent
  • Age 18 to 80 years at the time of stroke onset
  • Early rehabilitation period up to 6 months post-stroke
  • Diagnosis of acute cerebrovascular accident confirmed by MRI or CT
  • Upper limb weakness with severity between 0 and 3 on the 6-point Medical Research Council muscle strength scale
  • Ability and willingness to comply with the study protocol
  • Demonstrated motivation for rehabilitation
Not Eligible

You will not qualify if you...

  • Montreal Cognitive Assessment score less than 10 points
  • Hamilton Depression Rating Scale score greater than 18 points
  • Modified Rankin Scale score greater than 4 points
  • Pre-existing conditions causing decreased muscle strength or increased muscle tone in the upper limbs, or rigidity
  • Advanced arthritis or significant limitation of upper limb range of motion
  • Absence of part of the upper limb due to amputation
  • Any medical condition affecting study conduct or patient safety
  • Alcohol abuse or recreational drug use within 12 months prior to study
  • Use of experimental medications or medical devices within 30 days prior to study
  • Inability to comply with research procedures
  • Neurological or physical status preventing full rehabilitation
  • Visual acuity less than 0.2 in the weakest eye
  • Unstable angina or heart attack within 30 days prior to study
  • Recurrent stroke
  • Uncontrolled arterial hypertension
  • Ataxia
  • Presence of pacemaker or other implanted electronic devices
  • Use of muscle relaxants
  • Peripheral neuropathy
  • Coexisting diseases in exacerbation or decompensated stage requiring active treatment
  • Allergic reactions or skin lesions at EEG electrode sites
  • Acute urinary tract infections
  • Acute thrombophlebitis
  • Any form of epilepsy
  • Benign or malignant tumors

AI-Screening

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Trial Site Locations

Total: 1 location

1

Samara Regional Clinical Hospital named after V.D. Seredavin

Samara, Samara Oblast, Russia, 443095

Actively Recruiting

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Research Team

V

Vladimir Bulanov

A

Alexander Zakharov, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

Frequently Asked Questions

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Neurorehabilitation Using Robotics, Brain-Computer Interface, and Virtual Reality for Arm Weakness After Stroke in Early Recovery | DecenTrialz