StrokeNCT06557681
The Effect of Virtual Reality Treadmill-Based Gait Training on Gait and Balance Ability in Chronic Stroke Patients
A study testing Virtual Reality-Treadmill Training Group (VTT) and Conventional Therapy Group (CT) in people with Stroke and Hemiplegia, run by Yonsei University at 1 site in South Korea.
Trial summary
Walking independence is one of the most important goals for stroke patients and a major factor influencing their return to society after the onset of stroke. Stroke patients experience walking difficulties due to hemiplegia and have an increased risk of falls due to impaired balance ability. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Virtual Reality-Treadmill Training Group (VTT) and Conventional Therapy Group (CT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Mar 2024to 27 Sep 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 years or older.
- Confirmed diagnosis of stroke by a neurologist or neurosurgeon through radiological methods such as CT or MRI.
- Chronic hemiplegic stroke patients, six months post-stroke onset.
- Patients with a Functional Ambulatory Category score of 3 or higher.
- Patients with a Mini-Mental State Examination (MMSE) score of 10 or higher, who understand the study, are willing to participate voluntarily, and have given consent to participate.
Who cannot join
- Acute/subacute stroke patients within six months of stroke symptom onset.
- Patients with quadriplegia.
- Patients with ataxia.
- Patients with severe joint contracture of the lower limbs that makes wearing orthotics difficult.
- Patients with neurological, musculoskeletal, or cardiopulmonary diseases that affect walking.
- Any other cases deemed inappropriate for participation by the researcher.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Seoul
About this study
Walking independence is one of the most important goals for stroke patients and a major factor influencing their return to society after the onset of stroke. Stroke patients experience walking difficulties due to hemiplegia and have an increased risk of falls due to impaired balance ability. Recent studies have shown that treadmill-based walking training incorporating virtual reality can help improve walking and balance functions in actual stroke patients. However, there are few randomized clinical trials with control groups, highlighting the need for further research to ensure the reliability of clinical effects.
Therefore, this study aims to investigate the impact of treadmill-based training incorporating virtual reality on walking and balance functions. The training equipment to be used is the C-mill VR+ device, which enables walking training and assessment, balance training and assessment, and obstacle training using a front screen and treadmill videos. The investigators intend to thoroughly examine the walking ability and balance ability of the subjects obtained through this equipment, along with various evaluation tools.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Virtual Reality-Treadmill Training Group (VTT), Conventional Therapy Group (CT)
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Treadmill Training Group (VTT)Device
The Virtual Reality-Treadmill Training Group (VTT) will consist of 15 participants who will undergo 12 training sessions over 6 weeks, with each session occurring twice a week. Each session will include 30 minutes of conventional rehabilitation therapy followed by an additional 30 minutes of virtual reality-treadmill training. The sequence of these therapies can vary with each session. The virtual reality-treadmill training, conducted under the supervision of a therapist, will focus on five key components: precision stepping, obstacle negotiation, direction of progression, precision acceleration, and walking velocity. Evaluations of walking and balance abilities will be conducted before and after the intervention.
Conventional Therapy Group (CT)Other
The Conventional Therapy Group (CT) will consist of 15 participants who will undergo 12 training sessions over 6 weeks, with each session occurring twice a week. Each session will include 30 minutes of conventional rehabilitation therapy, aimed at improving walking and balance functions. The therapy will be administered by a therapist and may include exercises focused on muscle strength increase, gait training for step length and walking speed improvement, and balance training. Evaluations of walking and balance abilities will be conducted before and after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Receives conventional therapy (physical therapy) Receives: Device: Virtual Reality-Treadmill Training Group (VTT) |
| Control Group | Experimental | Receives conventional therapy (physical therapy) Receives: Other: Conventional Therapy Group (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Up and Go (TUG)
The Timed Up and Go (TUG) test is a simple and reliable assessment used to evaluate a patient's mobility and balance abilities. During the test, the patient starts seated in a chair, then stands up, walks 3 meters to a designated marker, turns around, walks back to the chair, and sits down. The time taken to complete this sequence is measured. Shorter completion times indicate better mobility and balance. The TUG test is widely used to assess walking ability and fall risk in various conditions, including stroke and geriatric disorders.
Measured: Pret-intervention Assessment
Time Up and Go (TUG)
The Timed Up and Go (TUG) test is a simple and reliable assessment used to evaluate a patient's mobility and balance abilities. During the test, the patient starts seated in a chair, then stands up, walks 3 meters to a designated marker, turns around, walks back to the chair, and sits down. The time taken to complete this sequence is measured. Shorter completion times indicate better mobility and balance. The TUG test is widely used to assess walking ability and fall risk in various conditions, including stroke and geriatric disorders.
Measured: Baseline (Pre-intervention) and immediately after intervention completion (6 weeks after intervention start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start25 Mar 2024
- Primary completion27 Sep 2024 (estimated)
- Study completion27 Sep 2024 (estimated)
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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557681
- Sponsor's protocol ID
- 1-2023-0088
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han SH, Jang HJ, Lee JW, Cheong JW, Kim YD, Nam HS, Kim DY. The effect of virtual reality-based treadmill gait training on functional mobility and balance in chronic stroke patients: a randomized controlled trial. Front Neurol. 2025 Jul 21;16:1603233. doi: 10.3389/fneur.2025.1603233. eCollection 2025.
PubMed 40761640
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Treadmill-Based Gait Training on Gait and Balance Ability in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06557681
- Acronym / sponsor ID
- 1-2023-0088
- Conditions
- Stroke, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 27 Sep 2024 (estimated)
- Study completion
- 27 Sep 2024 (estimated)
- First posted
- 16 Aug 2024 (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.
Walking independence is one of the most important goals for stroke patients and a major factor influencing their return to society after the onset of stroke. Stroke patients experience walking difficulties due to hemiplegia and have an increased risk of falls due to impaired balance ability. Recent studies have shown that treadmill-based walking training incorporating virtual reality can help improve walking and balance functions in actual stroke patients. However, there are few randomized clinical trials with control groups, highlighting the need for further research to ensure the reliability of clinical effects.
Therefore, this study aims to investigate the impact of treadmill-based training incorporating virtual reality on walking and balance functions. The training equipment to be used is the C-mill VR+ device, which enables walking training and assessment, balance training and assessment, and obstacle training using a front screen and treadmill videos. The investigators intend to thoroughly examine the walking ability and balance ability of the subjects obtained through this equipment, along with various evaluation tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Virtual Reality-Treadmill Training Group (VTT)Receives conventional therapy (physical therapy) |
| Control Group | Experimental | Other: Conventional Therapy Group (CT)Receives conventional therapy (physical therapy) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Virtual Reality-Treadmill Training Group (VTT)The Virtual Reality-Treadmill Training Group (VTT) will consist of 15 participants who will undergo 12 training sessions over 6 weeks, with each session occurring twice a week. Each session will include 30 minutes of conventional rehabilitation therapy followed by an additional 30 minutes of virtual reality-treadmill training. The sequence of these therapies can vary with each session. The virtual reality-treadmill training, conducted under the supervision of a therapist, will focus on five key components: precision stepping, obstacle negotiation, direction of progression, precision acceleration, and walking velocity. Evaluations of walking and balance abilities will be conducted before and after the intervention. | Device | Experimental Group |
| Conventional Therapy Group (CT)The Conventional Therapy Group (CT) will consist of 15 participants who will undergo 12 training sessions over 6 weeks, with each session occurring twice a week. Each session will include 30 minutes of conventional rehabilitation therapy, aimed at improving walking and balance functions. The therapy will be administered by a therapist and may include exercises focused on muscle strength increase, gait training for step length and walking speed improvement, and balance training. Evaluations of walking and balance abilities will be conducted before and after the intervention. | Other | Control Group |
Primary outcome
Time Up and Go (TUG)
Time frame: Pret-intervention Assessment
The Timed Up and Go (TUG) test is a simple and reliable assessment used to evaluate a patient's mobility and balance abilities. During the test, the patient starts seated in a chair, then stands up, walks 3 meters to a designated marker, turns around, walks back to the chair, and sits down. The time taken to complete this sequence is measured. Shorter completion times indicate better mobility and balance. The TUG test is widely used to assess walking ability and fall risk in various conditions, including stroke and geriatric disorders.
Time Up and Go (TUG)
Time frame: Baseline (Pre-intervention) and immediately after intervention completion (6 weeks after intervention start)
The Timed Up and Go (TUG) test is a simple and reliable assessment used to evaluate a patient's mobility and balance abilities. During the test, the patient starts seated in a chair, then stands up, walks 3 meters to a designated marker, turns around, walks back to the chair, and sits down. The time taken to complete this sequence is measured. Shorter completion times indicate better mobility and balance. The TUG test is widely used to assess walking ability and fall risk in various conditions, including stroke and geriatric disorders.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Derived from this study: PubMed 40761640Han SH, Jang HJ, Lee JW, Cheong JW, Kim YD, Nam HS, Kim DY. The effect of virtual reality-based treadmill gait training on functional mobility and balance in chronic stroke patients: a randomized controlled trial. Front Neurol. 2025 Jul 21;16:1603233. doi: 10.3389/fneur.2025.1603233. eCollection 2025.
- Individual participant dataSharing planned: No
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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 Virtual Reality-Treadmill Training Group (VTT) and Conventional Therapy Group (CT) in people with Stroke and Hemiplegia, run by Yonsei 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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?
Results are not available in the source record.
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?
Time Up and Go (TUG) (time frame: Pret-intervention Assessment). The study lists 2 primary outcomes in all. 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 NCT06557681, 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 16 Aug 2024.