NCT06806384

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sahmyook University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
OTHER	ExerGame-based Stroke Rehabilitation	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.
OTHER	General balance exercise for stroke rehabilitation	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.
OTHER	Conventional physical therapy for stroke rehabilitation	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.

Timeline

• Start date: 2023-10-07
• Primary completion: 2024-02-28
• Completion: 2024-03-31
• First posted: 2025-02-04
• Last updated: 2025-02-06

Locations

1 site across 1 country: South Korea