fNIRS Neurofeedback for Post-stroke Hand Rehabilitation

NCT07262528 | Recruiting

• 1 other identifier: 8/01/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular diseases are one of the main causes of disability. Among post-stroke individuals, 80% experience upper limb dysfunction, while only 5% to 20% of individuals regain full limb and hand function. The purpose of this study is to evaluate the effects of hand rehabilitation of post-stroke individuals using HEG Neurofeedback The study will include 30 participants in the early sub-acute phase post-stroke, who will be assigned to either the study group or the control group. Participants in the experimental group will follow a rehabilitation program extended with HEG Neurofeedback training, while participants in the control group will follow the standard rehabilitation program. The HEG Neurofeedback therapy equipment will be supplemented with new hand therapy software. During the exercises, patients will focus on a discussed and presented task, and once the expected level of concentration is reached, the software will trigger a virtual hand performing a finger flexion movement. Motor control of the hand will be assessed using the Fugl-Meyer Scale and Brunnström recovery stages.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Hand motor control - Fugl-Meyer Assessment (Upper Limb, Wrist, and Hand Section)

  Assessment will be performed using the Fugl-Meyer Assessment for the upper limb, including wrist and hand function, to evaluate motor recovery after stroke. The wrist section has a minimum score of 0 and a maximum score of 10, while the hand section has a minimum score of 0 and a maximum score of 14. In both sections, higher scores indicate better motor function.

  Baseline (Day 1)

• Hand motor control - Fugl-Meyer Assessment (Upper Limb, Wrist, and Hand Section)

  Assessment will be performed using the Fugl-Meyer Assessment for the upper limb, including wrist and hand function, to evaluate motor recovery after stroke. The wrist section has a minimum score of 0 and a maximum score of 10, while the hand section has a minimum score of 0 and a maximum score of 14. In both sections, higher scores indicate better motor function.

  Immediately after therapy completion (Day 15)

• Hand motor control - Brunnström Recovery Stages (Hand Section)

  Assessment will be performed using the hand section of the Brunnström Recovery Stages to classify the stage of motor recovery in the affected hand. The scale has a minimum value of 1 and a maximum value of 6. Higher values indicate better motor function and greater voluntary control of hand movements.

  Baseline (Day 1)

• Hand motor control - Brunnström Recovery Stages (Hand Section)

  Assessment will be repeated using the Brunnström Recovery Stages to determine any progression in hand motor recovery. The scale has a minimum value of 1 and a maximum value of 6. Higher values indicate better motor function and greater voluntary control of hand movements.

  Immediately after therapy completion (Day 15)

Study Arms (2)

Standard Rehabilitation supplemented with Biofeedback HEG

EXPERIMENTAL

Other: Standard Rehabilitation supplemented with Biofeedback HEG

Control: Standard Rehabilitation

OTHER

Other: Standard Rehabilitation

Interventions

Standard Rehabilitation supplemented with Biofeedback HEG OTHER

The experimental group will be provided with rehabilitation at the Rehabilitation Clinic and additional exercises with Biofeedback HEG. HEG therapy will be conducted for 15 days, every day from Monday to Friday. The duration of one session is 30 minutes. The HEG Neurofeedback therapy equipment will be supplemented with new hand therapy software. During the exercises, patients will focus on a discussed and presented task, and once the expected level of concentration is reached, the software will trigger a virtual hand performing a finger flexion movement.

Standard Rehabilitation supplemented with Biofeedback HEG

Standard Rehabilitation OTHER

Participants from the control group will be provided with rehabilitation at the Rehabilitation Clinic and an additional 30 minutes of individual physiotherapy focused on restoring hand function.

Control: Standard Rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals with hemiparesis after a first ischemic stroke,
• subacute stroke period (no longer than 3 months),
• upper limb paresis rated 2-4 by Brunnstrom recovery stages,
• participants aged 18 to 70 years,
• consent to participate in the study.

You may not qualify if:

• unstable general condition,
• visual field disorders,
• inability to sit independently,
• cognitive impairment (Mini-Mental State Examination, MMSE \> 24).

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszów

Rzeszów, 35-959, Poland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Agnieszka Guzik

CONTACT

+48 17 851 8965; aguzik@ur.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion: January 15, 2026
• Study Completion: May 6, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

PL (1)