fNIRS Neurofeedback for Post-stroke Hand Rehabilitation
NCT ID: NCT07262528
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-12-31
2026-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Rehabilitation supplemented with Biofeedback HEG
Standard Rehabilitation supplemented with Biofeedback HEG
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.
Control: Standard Rehabilitation
Standard Rehabilitation
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.
Interventions
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Standard Rehabilitation supplemented with Biofeedback HEG
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* visual field disorders,
* inability to sit independently,
* cognitive impairment (Mini-Mental State Examination, MMSE \> 24).
18 Years
70 Years
ALL
No
Sponsors
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University of Rzeszow
OTHER
Responsible Party
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Agnieszka Guzik, PhD
Principal Investigator
Central Contacts
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Other Identifiers
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8/01/2020
Identifier Type: -
Identifier Source: org_study_id