Smart Technologies in Early Post-Stroke Rehabilitation (SMART-Stroke)

Erika Endzelyte

Status: Not yet enrolling

Conditions: Stroke

Treatments: Device: Gloreha Aria; Other: Standard Occupational Therapy; Device: RecoveriX; Device: E-Link System

Study type: Interventional

Funder types: Other

Identifiers

NCT07171073

LSMU-2025-StrokeRehab

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

RecoveriX Group

Experimental group

Description:

Stroke patients receiving interactive rehabilitation with the RecoveriX brain-computer interface (BCI) system. Duration: 6-7 weeks, in addition to conventional rehabilitation.

Treatment:

Device: RecoveriX

Gloreha Aria Group

Experimental group

Description:

Stroke patients receiving robotic-assisted therapy with the Gloreha Aria system. Duration: 6-7 weeks, in addition to conventional rehabilitation.

Treatment:

Device: Gloreha Aria

E-Link Group

Experimental group

Description:

Stroke patients receiving computer-based interactive training with the E-Link system. Duration: 6-7 weeks, in addition to conventional rehabilitation.

Treatment:

Device: E-Link System

Standard Occupational Therapy Group

Active Comparator group

Description:

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

Treatment:

Other: Standard Occupational Therapy