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

NCT06806384 | Completed

• 1 other identifier: SYU 2023-10-007-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Functional Gait Assessment

  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.

  Baseline, after four weeks

Secondary Outcomes (3)

• Short Physical Performance Battery

  Baseline, after four weeks

• Trail Making Test A and B

  Baseline, after four weeks

• Stroop Test

  Baseline, after four weeks

Study Arms (2)

ExerGame group

EXPERIMENTAL

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.

Other: ExerGame-based Stroke Rehabilitation; Other: Conventional physical therapy for stroke rehabilitation

General balance exercise group

ACTIVE COMPARATOR

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.

Other: General balance exercise for stroke rehabilitation; Other: Conventional physical therapy for stroke rehabilitation

Interventions

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.

ExerGame group

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.

General balance exercise group

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.

ExerGame group; General balance exercise group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Sahmyook University

Seoul, Nowon-gu, 01795, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Stroke Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 4, 2025
• Study Start: October 7, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 31, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-01

Locations

KR (1)