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| Name | Class |
|---|---|
| The Hospital of Lithuanian University of Health Sciences Kaunas Clinics | UNKNOWN |
| Kulautuva Hospital of Rehabilitation | UNKNOWN |
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The goal of this interventional study is to evaluate the impact of applying different smart technologies during early rehabilitation after stroke. The primary hypothesis is that the use of smart technologies in the early stage of rehabilitation will significantly improve biosocial and cognitive functions, quality of life, and participation in activities. Furthermore, the extent of these improvements may differ depending on the type of technology used and individual patient characteristics.
The specific aims of the study are:
Assessments will be conducted at the beginning and end of the 6-7 week rehabilitation program, covering motor, cognitive, and biosocial functioning, as well as quality of life.
The results are expected to provide new knowledge on the effectiveness of smart technologies in stroke rehabilitation, to guide the development of personalized rehabilitation programs, and to support evidence-based decisions for occupational therapy and health care practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RecoveriX Group | Experimental | Stroke patients receiving interactive rehabilitation with the RecoveriX brain-computer interface (BCI) system. Duration: 6-7 weeks, in addition to conventional rehabilitation. |
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| Gloreha Aria Group | Experimental | Stroke patients receiving robotic-assisted therapy with the Gloreha Aria system. Duration: 6-7 weeks, in addition to conventional rehabilitation. |
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| E-Link Group | Experimental | Stroke patients receiving computer-based interactive training with the E-Link system. Duration: 6-7 weeks, in addition to conventional rehabilitation. |
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| Standard Occupational Therapy Group | Active Comparator | Stroke patients receiving conventional occupational therapy only. Duration: 6-7 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RecoveriX | Device | RecoveriX is a brain-computer interface (BCI) system designed for motor rehabilitation after stroke. It records brain activity using EEG and provides real-time feedback through virtual reality and functional electrical stimulation (FES). Participants imagine hand movements, and the system activates corresponding virtual movements and stimulates the muscles to support motor recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in biosocial functions | Measured using the Functional Independence Measure (FIM), a standardized tool assessing functional independence in activities of daily living. Scores range from 18 to 126, with higher scores indicating greater functional independence. | Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Change in cognitive functions | Measured using the Montreal Cognitive Assessment (MoCA), a screening tool for cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function. | Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Change in quality of life | Measured using the Short Form-36 (SF-36) questionnaire. Scores range from 0 to 100 for each domain, with higher scores indicating better quality of life. | Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain and fatigue levels | Measured using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 (no pain/fatigue) to 10 (worst imaginable pain/fatigue). | Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Change in motivation and willpower |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daiva Petruševičienė, Prof. | Contact | +370 37 327 315 | daiva.petruseviciene@lsmu.lt | |
| Erika Endzelytė, MSc | Contact | +370 37 327051 | erika.endzelyte@lsmu.lt |
| Name | Affiliation | Role |
|---|---|---|
| Vaiva Lesauskaitė, Prof. habil. dr. | Lithuanian University of Health Sciences (LSMU) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Neurorehabilitation Department | Kaunas | Kauno | 50161 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40428890 | Result | Endzelyte E, Petruseviciene D, Kubilius R, Mingaila S, Rapoliene J, Rimdeikiene I. Integrating Brain-Computer Interface Systems into Occupational Therapy for Enhanced Independence of Stroke Patients: An Observational Study. Medicina (Kaunas). 2025 May 21;61(5):932. doi: 10.3390/medicina61050932. |
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The decision on IPD sharing has not yet been made and will depend on institutional and ethical considerations.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Outcome assessors will be blinded to group assignment; participants and care providers will be aware of the intervention.
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| Gloreha Aria | Device | Gloreha Aria is a robotic therapy system for upper limb rehabilitation. It combines mechanical assistance with virtual reality tasks to restore hand and finger movements. The device can be used in passive, assistive, or active modes, depending on the patient's abilities, and provides interactive exercises to improve motor function and neuroplasticity. |
|
| E-Link System | Device | E-Link is an interactive computer-based system for hand and finger rehabilitation. It uses sensors to capture movements and provides individualized motor training through interactive tasks. The system allows both active motor practice and objective assessment of fine motor skills and functional abilities. |
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| Standard Occupational Therapy | Other | The control group will receive conventional occupational therapy as part of standard rehabilitation. Therapy will include individualized exercises to improve motor, cognitive, and functional abilities, consistent with usual clinical practice. |
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Measured using The Volition Questionnaire, which evaluates volition and motivation for rehabilitation. Scores range from 1 to 4 per item, with higher scores indicating stronger volition. |
| Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Participation in daily activities | Measured using the Canadian Occupational Performance Measure (COPM). Performance and satisfaction scores range from 1 to 10, with higher scores indicating greater performance and satisfaction. | Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Upper extremity motor function | Measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Scores range from 0 to 66, with higher scores indicating better motor function. | Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Gross manual dexterity | Measured using the Box and Block Test. The score is the number of blocks moved in 60 seconds, with higher scores indicating better dexterity. | Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Fine motor dexterity | Measured using the Nine-Hole Peg Test. The score is the time (in seconds) to place and remove nine pegs, with lower times indicating better dexterity. | Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Grip strength | Measured using a hand dynamometer. Grip strength is recorded in kilograms of force, with higher scores indicating greater strength. | Baseline (Day 1) and after 6 weeks of rehabilitation. |
| Lithuanian University of Health Sciences, Hospital Kaunas Clinics, Kulautuva Rehabilitation Hospital | Kaunas | Kauno | 53483 | Lithuania |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |