NCT Number: NCT07171073
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 opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Neurorehabilitation Department, Kaunas, Kauno, Lithuania
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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 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.
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.
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
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.
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
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.
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
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.
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 (no pain/fatigue) to 10 (worst imaginable pain/fatigue).
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using The Volition Questionnaire, which evaluates volition and motivation for rehabilitation. Scores range from 1 to 4 per item, with higher scores indicating stronger volition.
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Canadian Occupational Performance Measure (COPM). Performance and satisfaction scores range from 1 to 10, with higher scores indicating greater performance and satisfaction.
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Scores range from 0 to 66, with higher scores indicating better motor function.
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Box and Block Test. The score is the number of blocks moved in 60 seconds, with higher scores indicating better dexterity.
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Nine-Hole Peg Test. The score is the time (in seconds) to place and remove nine pegs, with lower times indicating better dexterity.
Time frame: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using a hand dynamometer. Grip strength is recorded in kilograms of force, with higher scores indicating greater strength.
Contact information is provided by the study sponsor or research team.
Daiva Petruševičienė, Prof.
CONTACT
Erika Endzelytė, MSc
CONTACT
Erika Endzelyte
Other
Changes in Biosocial and Cognitive Functions and Quality of Life When Applying Different Smart Technologies in Stroke Patients During Early Rehabilitation
Acronym: SMART-Stroke
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