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Completed

NCT Number: NCT06806384

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahmyook University

Seoul, Nowon-gu, 01795, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ExerGame-based Stroke Rehabilitation

Other

The intervention involves training using the Dividat Senso platform (Dividat, Schindellegi, Switzerland), a pressure-sensitive platform (1.13 m × 1.13 m) equipped with 20 sensors. The training includes a series of ExerGames designed to challenge balance, coordination, and cognitive processing speed. These games focus on weight shifting, stepping accuracy, and reaction time, with difficulty levels progressively adjusted based on participant performance. To ensure safety, participants are allowed to use a waist-high parallel bar for support during the exercises. Additionally, participants receive conventional physical therapy methods that do not interfere with the study protocol. These include range-of-motion exercises, upper-limb training, and respiratory training, delivered in 30-minute sessions, five days per week, over a four-week period.

General balance exercise for stroke rehabilitation

Other

The intervention consists of a standardized program of balance exercises designed to improve postural control and stability. The program incorporates weight-shifting training performed once daily for 30 minutes, five days per week, over a four-week period. Weight-shifting activities include anterior-posterior and mediolateral movements, with a focus on loading the affected limb. Participants are instructed to adopt a lunge posture for forward-backward movements, maintain parallel foot positioning for lateral movements, and utilize a balance pad to enhance postural stability. A trained therapist adjusts the intensity and difficulty of the exercises to match the individual abilities of each participant, ensuring a personalized and progressive approach.

Conventional physical therapy for stroke rehabilitation

Other

The intervention includes conventional physical therapy methods that are compatible with the study protocol. These methods consist of range-of-motion exercises, upper-limb training, and respiratory training. The sessions are delivered for 30 minutes per day, five days per week, over a four-week period.

Primary outcomes

  1. Functional Gait Assessment

    Time frame: 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 outcomes

  1. Short Physical Performance Battery

    Time frame: 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

  2. Trail Making Test A and B

    Time frame: 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.

  3. Stroop Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sahmyook University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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