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

Sahmyook University

Status: Completed

Conditions: Stroke

Treatments: Other: General balance exercise for stroke rehabilitation; Other: Conventional physical therapy for stroke rehabilitation; Other: ExerGame-based Stroke Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06806384

SYU 2023-10-007-001

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

ExerGame group

Experimental group

Description:

Participants in the experimental group train using the Dividat Senso platform, a pressure-sensitive device equipped with 20 sensors. They engage in ExerGames designed to improve balance, coordination, and cognitive processing speed through tasks such as weight shifting, stepping accuracy, and reaction time, with difficulty levels adjusted based on performance. A waist-high parallel bar is available for support to ensure safety during the exercises. In addition to this training, participants receive 30-minute sessions of conventional physical therapy, including range-of-motion exercises, upper-limb training, and respiratory training, five days per week over a four-week period.

Treatment:

Other: ExerGame-based Stroke Rehabilitation

Other: Conventional physical therapy for stroke rehabilitation

General balance exercise group

Active Comparator group

Description:

Participants in the general balance group follow a standardized program of balance exercises aimed at improving postural control and stability. The program includes daily 30-minute sessions of weight-shifting activities, focusing on anterior-posterior and mediolateral movements, with an emphasis on loading the affected limb. Exercises involve forward-backward lunges, lateral movements with parallel foot positioning, and standing on a balance pad to enhance postural stability. In addition to the balance exercises, participants also receive conventional physical therapy, including range-of-motion exercises, upper-limb training, and respiratory training, provided for 30 minutes per day, five days per week, over four weeks.

Treatment:

Other: Conventional physical therapy for stroke rehabilitation

Other: General balance exercise for stroke rehabilitation