Effects of Cognitive-Motor Exergame Using Dividat Senso on Physical and Cognitive Function in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT06806384
• Lead Sponsor: Sahmyook University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-07
• Primary Completion: 2024-02-28
• Study Completion: 2024-03-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Gait Assessment	Baseline, after four weeks	The Functional Gait Assessment is an instrument designed to assess postural stability during ambulation and the individual's ability to perform various tasks while walking. Scores are assigned on an ordinal scale from 0 to 3, with a total score of 30.

Secondary Outcome Measures

Name	Time	Method
Short Physical Performance Battery	Baseline, after four weeks	The Short Physical Performance Battery is a physical performance test used to assess lower extremity function in older adults. It consists of three components: balance, gait speed, and chair stand (5 repetitions). Each task is scored from 0 (inability to perform) to 4, based on performance differences, with a maximum total score of 12. Although this tool is commonly used to quantify lower extremity function in older adults, it can also assess more challenging endurance-based long-distance performance, differentiating it from traditional clinical assessment tools for stroke patients
Trail Making Test A and B	Baseline, after four weeks	The Trail Making Test consists of two parts: Part A, in which participants connect 25 numbered circles on a page, and Part B, in which participants alternately connect numbered and lettered circles. Trail Making Test-A measures visual scanning and processing speed, while Trail Making Test-B assesses divided attention, set-shifting, and cognitive flexibility. The participants' reaction times (in seconds) and the number of errors were recorded.
Stroop Test	Baseline, after four weeks	The Stroop Test assesses selective attention and interference sensitivity. It consists of three parts: a page with color names printed in matching ink colors, a page with meaningless symbols (X's) printed in various ink colors, and a page with color names printed in incongruent ink colors (e.g., the word "blue" printed in red ink). In this study, the third part (incongruent color names) was used for testing, and the participants' completion time and the number of errors were recorded.

Trial Locations

Locations (1)

Sahmyook University; 🇰🇷 Seoul, Nowon-gu, Korea, Republic of