NCT07171073

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable stroke

Timeline
32mo left

Started Sep 2025

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Sep 2025Dec 2028

First Submitted

Initial submission to the registry

August 28, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

August 28, 2025

Last Update Submit

September 5, 2025

Conditions

Stroke

Keywords

Stroke rehabilitationCognitive functionQuality of lifeSmart technologiesVirtual realityBrain-computer interface (BCI)Robot-assisted rehabilitationOccupational therapy

Outcome Measures

Primary Outcomes (3)

  • 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.

Secondary Outcomes (7)

  • Change in pain and fatigue levels

    Baseline (Day 1) and after 6 weeks of rehabilitation.

  • Change in motivation and willpower

    Baseline (Day 1) and after 6 weeks of rehabilitation.

  • Participation in daily activities

    Baseline (Day 1) and after 6 weeks of rehabilitation.

  • Upper extremity motor function

    Baseline (Day 1) and after 6 weeks of rehabilitation.

  • Gross manual dexterity

    Baseline (Day 1) and after 6 weeks of rehabilitation.

  • +2 more secondary outcomes

Study Arms (4)

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.

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.

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.

Device: E-Link System

Standard Occupational Therapy Group

ACTIVE COMPARATOR

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

Other: Standard Occupational Therapy

Interventions

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.

RecoveriX Group
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.

Gloreha Aria Group
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.

E-Link Group
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.

Standard Occupational Therapy Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Kaunas, Kauno, 50161, Lithuania

Location

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

Kaunas, Kauno, 53483, Lithuania

Location

Related Publications (1)

  • 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.

    PMID: 40428890BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Vaiva Lesauskaitė, Prof. habil. dr.

    Lithuanian University of Health Sciences (LSMU)

    STUDY DIRECTOR

Central Study Contacts

Daiva Petruševičienė, Prof.

CONTACT

+370 37 327 315daiva.petruseviciene@lsmu.lt

Erika Endzelytė, MSc

CONTACT

+370 37 327051erika.endzelyte@lsmu.lt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to group assignment; participants and care providers will be aware of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 12, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

LI(2)