StrokeSMART-StrokeNCT07171073
Smart Technologies in Early Post-Stroke Rehabilitation
A study testing RecoveriX, Gloreha Aria and E-Link System in people with Stroke, run by Erika Endzelyte at 2 sites in Lithuania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- RecoveriX, Gloreha Aria and E-Link System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesLithuania
- Study dates
- 15 Sep 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Previous significant arm function deficits unrelated to stroke.
- Severe visual or hearing impairments interfering with participation.
- Unilateral neglect syndrome (Hemispatial neglect).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Neurorehabilitation Department
Kaunas, Kauno, 50161
Erika Endzelyte, MSc, +370 37 327051, erika.endzelyte@lsmu.lt
Daiva Petruševičienė, Prof.
Lithuanian University of Health Sciences, Hospital Kaunas Clinics, Kulautuva Rehabilitation Hospital
Kaunas, Kauno, 53483
Erika Endzelytė, MSc, +370 37 327051, erika.endzelyte@lsmu.lt
Daiva Petruševičienė, Prof.
About this study
Official title: Changes in Biosocial and Cognitive Functions and Quality of Life When Applying Different Smart Technologies in Stroke Patients During Early Rehabilitation
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:
Read more
- 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.
- Conditions
- Stroke
- Being tested
- RecoveriX, Gloreha Aria, E-Link System, Standard Occupational Therapy
- Keywords
- Stroke rehabilitation, Cognitive function, Quality of life, Smart technologies, Virtual reality, Brain-computer interface (BCI), Robot-assisted rehabilitation, Occupational therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecoveriXDevice
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.
Gloreha AriaDevice
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 SystemDevice
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.
Standard Occupational TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RecoveriX |
| Gloreha Aria Group | Experimental | Stroke patients receiving robotic-assisted therapy with the Gloreha Aria system.
Duration: 6-7 weeks, in addition to conventional rehabilitation. Receives: Device: Gloreha Aria |
| 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. Receives: Device: E-Link System |
| Standard Occupational Therapy Group | Active comparator | Stroke patients receiving conventional occupational therapy only. Duration: 6-7 weeks. Receives: Other: Standard Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and after 6 weeks of rehabilitation.
Secondary outcomes (7)
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).
Measured: Baseline (Day 1) and after 6 weeks of rehabilitation.
Change in motivation and willpower
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and after 6 weeks of rehabilitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erika Endzelyte
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kulautuva Hospital of Rehabilitation
- Responsible party
- Sponsor-investigator, Erika Endzelyte, Lithuanian University of Health Sciences
- Investigators
- Vaiva Lesauskaitė, Prof. habil. dr., Study director, Lithuanian University of Health Sciences (LSMU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171073
- Sponsor's protocol ID
- LSMU-2025-StrokeRehab
- Acronym
- SMART-Stroke
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision on IPD sharing has not yet been made and will depend on institutional and ethical considerations.
Publications
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.
PubMed 40428890
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Biosocial and Cognitive Functions and Quality of Life When Applying Different Smart Technologies in Stroke Patients During Early Rehabilitation
- ClinicalTrials.gov ID
- NCT07171073
- Acronym / sponsor ID
- SMART-Stroke / LSMU-2025-StrokeRehab
- Conditions
- Stroke
- Keywords
- Stroke rehabilitation, Cognitive function, Quality of life, Smart technologies, Virtual reality, Brain-computer interface (BCI), Robot-assisted rehabilitation, Occupational therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erika EndzelyteUniversity, hospital or other
- Collaborators
- The Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kulautuva Hospital of Rehabilitation
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RecoveriX Group | Experimental | Device: RecoveriXStroke patients receiving interactive rehabilitation with the RecoveriX brain-computer interface (BCI) system. Duration: 6-7 weeks, in addition to conventional rehabilitation. |
| Gloreha Aria Group | Experimental | Device: Gloreha AriaStroke patients receiving robotic-assisted therapy with the Gloreha Aria system. Duration: 6-7 weeks, in addition to conventional rehabilitation. |
| E-Link Group | Experimental | Device: E-Link SystemStroke patients receiving computer-based interactive training with the E-Link system. Duration: 6-7 weeks, in addition to conventional rehabilitation. |
| Standard Occupational Therapy Group | Active comparator | Other: Standard Occupational TherapyStroke patients receiving conventional occupational therapy only. Duration: 6-7 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RecoveriXRecoveriX 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. | Device | RecoveriX Group |
| Gloreha AriaGloreha 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. | Device | Gloreha Aria Group |
| E-Link SystemE-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. | Device | E-Link Group |
| Standard Occupational TherapyThe 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. | Other | Standard Occupational Therapy Group |
Primary outcome
Change in biosocial functions
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Change in pain and fatigue levels
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Change in motivation and willpower
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Participation in daily activities
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Upper extremity motor function
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Gross manual dexterity
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Fine motor dexterity
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Grip strength
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 40428890Endzelyte 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.
- Individual participant dataSharing planned: Undecided. The decision on IPD sharing has not yet been made and will depend on institutional and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vaiva Lesauskaitė, Prof. habil. dr. study director
Lithuanian University of Health Sciences (LSMU)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RecoveriX, Gloreha Aria and E-Link System in people with Stroke, run by Erika Endzelyte at 2 sites in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daiva Petruševičienė, Prof. (+370 37 327 315, daiva.petruseviciene@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in biosocial functions (time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07171073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.