Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07262528

fNIRS Neurofeedback for Post-stroke Hand Rehabilitation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study is a prospective, randomized, single-blind clinical trial with intervention. Participants will be recruited from among patients treated at the Rehabilitation Clinic. Inclusion criteria: 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. Exclusion criteria: unstable general condition, visual field disorders, inability to sit independently, cognitive impairment (Mini-Mental State Examination, MMSE > 24). The minimum size of the sample was calculated taking into account the number of individuals after stroke hospitalized annually in the re habilitation ward, i.e. approximately 120 patients, of which those in the acute phase of recovery constitute about 40%. It was assumed that 80% of the patients would have a minimum 2 in Brunnstrom scale. A fraction size of 0.8 was used, with a maximum error of 5%, a sample size of 30 patients was obtained.

The allocation of interventions will be determined based on a simple randomization sequence generated using Microsoft Excel. The study coordinator will register participants, generate the random allocation sequence, and assign and schedule participants for the interventions.

Fifteen participants will be assigned to the experimental group and fifteen to the control group.

Interwention. 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. 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.

Participants will be assessed twice, before the start of the therapy series and immediately after its completion. Motor control of the hand will be assessed using the Fugl-Meyer Scale and Brunnström recovery stages.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

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.

Primary outcomes

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

    Time frame: Baseline (Day 1)

    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.

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

    Time frame: Immediately after therapy completion (Day 15)

    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.

  3. Hand motor control - Brunnström Recovery Stages (Hand Section)

    Time frame: Baseline (Day 1)

    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.

  4. Hand motor control - Brunnström Recovery Stages (Hand Section)

    Time frame: Immediately after therapy completion (Day 15)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Agnieszka Guzik

CONTACT

[email protected]

+48 17 851 8965

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Registry information

Official study title

Hand Rehabilitation in People With Hemiparesis After a Stroke Using 3D Imaging With fNIRS Neurofeedback

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.