Smart Technologies in Early Post-Stroke Rehabilitation

N/ANot Yet RecruitingNCT07171073

Erika Endzelyte200 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.