StrokeNCT06806384
Effects of Cognitive-Motor Exergame Using Dividat Senso on Physical and Cognitive Function in Stroke Patients
A study testing ExerGame-based Stroke Rehabilitation, General balance exercise for stroke rehabilitation and Conventional physical therapy for stroke rehabilitation in people with Stroke, run by Sahmyook University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- ExerGame-based Stroke Rehabilitation, General balance exercise for stroke rehabilitation and Conventional physical therapy for stroke rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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?
Read more
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
- Being tested
- ExerGame-based Stroke Rehabilitation, General balance exercise for stroke rehabilitation, Conventional physical therapy for stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerGame-based Stroke RehabilitationOther
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 rehabilitationOther
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 rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: General balance exercise for stroke rehabilitation; Other: Conventional physical therapy for stroke rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after four weeks
Secondary outcomes (3)
Short Physical Performance Battery
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
Measured: Baseline, after four weeks
Trail Making Test A and B
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.
Measured: Baseline, after four weeks
Stroop Test
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.
Measured: Baseline, after four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start7 Oct 2023
- Primary completion28 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changho Song, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806384
- Sponsor's protocol ID
- SYU 2023-10-007-001
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jo S, Kim H, Song C. Dual-task exergaming to enhance motor and cognitive function in chronic stroke: a prospective, assessor-blinded, parallel group randomized controlled trial. J Neuroeng Rehabil. 2026 Feb 19;23(1):103. doi: 10.1186/s12984-026-01913-y.
PubMed 41715216
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive-Motor Exergame Using Dividat Senso on Physical and Cognitive Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT06806384
- Acronym / sponsor ID
- SYU 2023-10-007-001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ExerGame group | Experimental | Other: ExerGame-based Stroke Rehabilitation, Other: Conventional physical therapy for stroke rehabilitationParticipants 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. |
| General balance exercise group | Active comparator | Other: General balance exercise for stroke rehabilitation, Other: Conventional physical therapy for stroke rehabilitationParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerGame-based Stroke RehabilitationThe 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 | ExerGame group |
| General balance exercise for stroke rehabilitationThe 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 | General balance exercise group |
| Conventional physical therapy for stroke rehabilitationThe 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. | Other | ExerGame group, General balance exercise group |
Primary outcome
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.
3 secondary outcomes
Short Physical Performance Battery
Time frame: Baseline, after four weeks
Trail Making Test A and B
Time frame: Baseline, after four weeks
Stroop Test
Time frame: Baseline, after four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 41715216Jo S, Kim H, Song C. Dual-task exergaming to enhance motor and cognitive function in chronic stroke: a prospective, assessor-blinded, parallel group randomized controlled trial. J Neuroeng Rehabil. 2026 Feb 19;23(1):103. doi: 10.1186/s12984-026-01913-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExerGame-based Stroke Rehabilitation, General balance exercise for stroke rehabilitation and Conventional physical therapy for stroke rehabilitation in people with Stroke, run by Sahmyook University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Gait Assessment (time frame: Baseline, after four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06806384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.