Stroke
Conditions
Keywords
Stroke rehabilitation, Cognitive function, Quality of life, Smart technologies, Virtual reality, Brain-computer interface (BCI), Robot-assisted rehabilitation, Occupational therapy
Brief summary
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: * To evaluate changes in biosocial and cognitive functions in stroke patients using different smart technologies during early rehabilitation. * To assess changes in quality of life and participation in daily activities. * To compare the effectiveness of different smart technologies on recovery outcomes. * To identify patient-specific factors influencing rehabilitation results. A total of four groups will be studied. Three experimental groups will receive interventions with different interactive rehabilitation technologies (RecoveriX, Gloreha Aria, E-Link). The control group will undergo standard occupational therapy. All groups will receive the same level of conventional rehabilitation and medical care. 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.
Interventions
DEVICERecoveriX
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.
DEVICEGloreha Aria
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.
DEVICEE-Link System
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.
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.
Sponsors
The Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kulautuva Hospital of Rehabilitation
Erika Endzelyte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to group assignment; participants and care providers will be aware of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent. * Ischemic stroke confirmed by imaging (CT or MRI). * Hemiplegia/hemiparesis with arm motor deficit (muscle strength ≤ 4 points on Lovett scale). * Time since stroke ≤ 1 month. * No severe cognitive impairment (MMSE ≥ 18). * Native Lithuanian speaker.
Exclusion criteria
* Declines participation. * Contraindications for RecoveriX (metallic implants in the head, cochlear implants, cardiac pacemaker). * Previous craniotomy or severe head trauma with loss of consciousness. * Epilepsy or history of seizures. * Severe aphasia or severe comprehension impairment (MMSE \< 18). * Severe comorbidities affecting biosocial functions. * Previous significant arm function deficits unrelated to stroke. * Severe visual or hearing impairments interfering with participation. * Unilateral neglect syndrome (Hemispatial neglect).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in biosocial functions | Baseline (Day 1) and after 6 weeks of rehabilitation. | 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. |
| Change in cognitive functions | Baseline (Day 1) and after 6 weeks of rehabilitation. | 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. |
| Change in quality of life | Baseline (Day 1) and after 6 weeks of rehabilitation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity motor function | Baseline (Day 1) and after 6 weeks of rehabilitation. | Measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Scores range from 0 to 66, with higher scores indicating better motor function. |
| Gross manual dexterity | Baseline (Day 1) and after 6 weeks of rehabilitation. | Measured using the Box and Block Test. The score is the number of blocks moved in 60 seconds, with higher scores indicating better dexterity. |
| Change in motivation and willpower | Baseline (Day 1) and after 6 weeks of rehabilitation. | 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. |
| Grip strength | Baseline (Day 1) and after 6 weeks of rehabilitation. | Measured using a hand dynamometer. Grip strength is recorded in kilograms of force, with higher scores indicating greater strength. |
| Fine motor dexterity | Baseline (Day 1) and after 6 weeks of rehabilitation. | 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. |
| Change in pain and fatigue levels | Baseline (Day 1) and after 6 weeks of rehabilitation. | Measured using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 (no pain/fatigue) to 10 (worst imaginable pain/fatigue). |
| Participation in daily activities | Baseline (Day 1) and after 6 weeks of rehabilitation. | 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. |
Countries
Lithuania
Contacts
Primary ContactDaiva Petruševičienė, Prof.
Backup ContactErika Endzelytė, MSc
Outcome results
None listed