Clinical trial NCT06806384: Effects of Cognitive-Motor Exergame Using Dividat Senso on Physical and Cognitive Function in Stroke Patients
Official title: Effects of Cognitive-Motor Exergame Using Dividat Senso on Physical and Cognitive Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized controlled trial is to assess whether exergaming using the Dividat Senso platform more effectively enhances physical and cognitive functions in patients with chronic stroke compared to standard balance exercises. The primary questions it seeks to answer are:

* Does exergaming with the Dividat Senso lead to greater improvements in physical function, as measured by outcomes such as the Functional Gait Assessment and the Short Physical Performance Battery?
* Does exergaming with the Dividat Senso result in greater enhancements in cognitive function, evaluated through measures such as the Trail Making Test (Parts A and B) and the Stroop Test?

Researchers will compare two groups:

* An ExerGame group, receiving exergaming with the Dividat Senso in addition to standard rehabilitation.
* A Control group, receiving standard balance exercises.

Participants will:

* Undergo a four-week training period, consisting of five sessions per week, with each session lasting 30 minutes.
* Receive standard rehabilitation, including neurodevelopmental treatment and occupational therapy, alongside their assigned balance or exergame exercises.
* Complete baseline and post-intervention assessments of physical function (using the Functional Gait Assessment and the Short Physical Performance Battery) and cognitive function (using the Trail Making Test and the Stroop Test).
* During each exergame session, participants in the ExerGame group will interact with the Dividat Senso platform, performing weight-shifting, stepping, and task-oriented balancing exercises guided by real-time feedback on a virtual interface.
* Participants in the Control group will perform standard balance exercises emphasizing weight transfer in anterior-posterior and medial-lateral directions.

This study aims to clarify the efficacy of exergaming as a dual-task intervention for chronic stroke rehabilitation, potentially offering a more engaging and effective approach to improving both motor and cognitive functions.


Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic stroke (≥6 months post-stroke) confirmed by medical records
* a score of 21 or higher on the Korean version of the Mini-Mental State Examination
* ability to walk independently ≥10 meters with or without assistive devices

Exclusion Criteria:

* hemianopia
* other neurological disorders (e.g., Parkinson's disease, multiple sclerosis)
* progressive or uncontrolled medical conditions (e.g., unstable cardiac disease, uncontrolled diabetes)
* musculoskeletal conditions that could interfere with balance or gait performance
* participation in other interventional studies within the past year

Primary outcomes:
measure: Functional Gait Assessment
timeFrame: Baseline, after four weeks
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: Baseline, after four weeks
measure: Trail Making Test A and B
timeFrame: Baseline, after four weeks
measure: Stroop Test
timeFrame: Baseline, after four weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sahmyook University
state: Nowon-gu
Study officials:
References: