fNIRS Neurofeedback for Post-stroke Hand Rehabilitation
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Rzeszow
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
unstable general condition,
visual field disorders,
inability to sit independently,
cognitive impairment (Mini-Mental State Examination, MMSE > 24).
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Rehabilitation supplemented with Biofeedback HEG
Other interventionThe 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 interventionParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Standard Rehabilitation supplemented with Biofeedback HEGExperimental treatment 1 intervention
Group B: Control: Standard RehabilitationOther 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline (Day 1)2
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.
Time frame
Immediately after therapy completion (Day 15)3
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.
Time frame
Baseline (Day 1)4
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.
Time frame
Immediately after therapy completion (Day 15)Sponsors and contacts
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Source ClinicalTrials.gov