Smart Technologies in Early Post-Stroke Rehabilitation

NCT ID: NCT07171073

Last Updated: 2025-09-12

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2028-12-31

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors will be blinded to group assignment; participants and care providers will be aware of the intervention.

Study Groups

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RecoveriX Group

Stroke patients receiving interactive rehabilitation with the RecoveriX brain-computer interface (BCI) system.

Duration: 6-7 weeks, in addition to conventional rehabilitation.

Group Type EXPERIMENTAL

RecoveriX

Intervention Type 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.

Gloreha Aria Group

Stroke patients receiving robotic-assisted therapy with the Gloreha Aria system.

Duration: 6-7 weeks, in addition to conventional rehabilitation.

Group Type EXPERIMENTAL

Gloreha Aria

Intervention Type 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 Group

Stroke patients receiving computer-based interactive training with the E-Link system.

Duration: 6-7 weeks, in addition to conventional rehabilitation.

Group Type EXPERIMENTAL

E-Link System

Intervention Type 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.

Standard Occupational Therapy Group

Stroke patients receiving conventional occupational therapy only. Duration: 6-7 weeks.

Group Type ACTIVE_COMPARATOR

Standard Occupational Therapy

Intervention Type 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.

Interventions

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RecoveriX

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.

Intervention Type DEVICE

Gloreha 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.

Intervention Type DEVICE

E-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.

Intervention Type DEVICE

Standard Occupational Therapy

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital of Lithuanian University of Health Sciences Kaunas Clinics

UNKNOWN

Sponsor Role collaborator

Kulautuva Hospital of Rehabilitation

UNKNOWN

Sponsor Role collaborator

Erika Endzelyte

OTHER

Sponsor Role lead

Responsible Party

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Erika Endzelyte

Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vaiva Lesauskaitė, Prof. habil. dr.

Role: STUDY_DIRECTOR

Lithuanian University of Health Sciences (LSMU)

Locations

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Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Neurorehabilitation Department

Kaunas, Kauno, Lithuania

Site Status

Lithuanian University of Health Sciences, Hospital Kaunas Clinics, Kulautuva Rehabilitation Hospital

Kaunas, Kauno, Lithuania

Site Status

Countries

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Lithuania

Central Contacts

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Daiva Petruševičienė, Prof.

Role: CONTACT

+370 37 327 315

Erika Endzelytė, MSc

Role: CONTACT

+370 37 327051

Facility Contacts

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Erika Endzelyte, MSc

Role: primary

+370 37 327051

Erika Endzelytė, MSc

Role: primary

+370 37 327051

References

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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.

Reference Type BACKGROUND
PMID: 40428890 (View on PubMed)

Other Identifiers

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LSMU-2025-StrokeRehab

Identifier Type: -

Identifier Source: org_study_id

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