Smart Technologies in Early Post-Stroke Rehabilitation

Official title

Changes in Biosocial and Cognitive Functions and Quality of Life When Applying Different Smart Technologies in Stroke Patients During Early Rehabilitation

Overview

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

• Device 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.
• 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.
• 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.
• Other 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.

Primary outcome measures

• Change in biosocial functions [Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.]
• Change in cognitive functions [Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.]
• Change in quality of life [Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.]

Secondary outcome measures (7)

• 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Lithuania · 2 centers

• Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Neurorehabilitation D — Kaunas
• Lithuanian University of Health Sciences, Hospital Kaunas Clinics, Kulautuva Rehabilitatio — Kaunas

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. PMID 40428890

Identifiers

NCT: NCT07171073 · LSMU-2025-StrokeRehab

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗