StrokeNCT06164197
Virtual Reality Based Robotic Gait and Balance Trainer
A study testing Lokomat, Thera Trainer Balo and Person-Specific Rehabilitation Program in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The aim of research is to examine and compare the effectiveness of virtual reality-based balance training and robot-assisted walking approaches on balance and gait in individuals post-stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Lokomat, Thera Trainer Balo and Person-Specific Rehabilitation Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2023to 31 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having the ICD-10 diagnosis code G.81 Hemiplegia
- At least 3 weeks having passed since the diagnosis (Subacute and cronic periods)
- Being 18 years of age or older
- Having a Berg Balance Score between 21-40 (indicating an acceptable balance)
- Being able to walk with or without support (FAC score of 2 or higher)
Who cannot join
- Having a known additional neurological or orthopedic problem that could affect balance
- Inability to adapt to virtual reality applications in Lokomat and Balance Trainer
- Diagnosis being more than 2 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Effects of Virtual Reality-Based Balance Training and Robot-Assisted Gait Training on Balance and Gait Performance in Individuals With Stroke
The aim of research is to examine and compare the effectiveness of virtual reality-based balance training and robot-assisted walking approaches on balance and gait in individuals post-stroke. Through the study, Investigators intend to reach conclusions regarding whether the focus should be on balance or walking training based on the Berg Balance Scale and Functional Ambulation Classification levels of stroke survivors. Subgroups will be formed in both groups based on Functional Ambulation and Berg Balance Scale scores. The balance and gait developments within these subgroups will be compared, aiming to determine at which levels balance or walking improvement is more pronounced. These findings are crucial for making the right choices in setting rehabilitation goals for individual patients.
Read the detailed description
Stroke is one of the leading causes of death in adults and results in severe disability. Within the first 3 months after a stroke, 20% of patients use a wheelchair, and 70% experience walking problems. Balance problems are among the most common issues after a stroke, impacting a patient's ability to sit, stand, transfer, and walk, thereby creating a risk of falls. Additionally, balance and walking quality are vital components, with abnormalities potentially leading to abnormal walking patterns, reduced walking speed, and spatiotemporal asymmetries. Therefore, improving balance and walking is a fundamental goal in stroke rehabilitation and holds priority for many patients and their families.
Robot-assisted gait training (RAGT) is an emerging and promising technological approach in stroke rehabilitation. RAGT provides safe, high-intensity, and task-oriented walking training with ample repetitions. Repetitive tasks can enhance neuroplasticity and motor learning, resulting in improved balance and walking speed.
Robotic systems come in two types: end-effector and exoskeleton. The Lokomat® FreeD (Hocoma AG, Switzerland) is an exoskeleton-type robot. Unlike the conventional Lokomat, the FreeD module allows pelvic translation to the right and left, along with rotation. These coordinated pelvic movements are mechanically facilitated by the device during walking. It is known that these movements are crucial for human walking and balance, and with the FreeD module, these pelvic movements have become part of robot-assisted gait training.
In a systematic review comparing Lokomat with conventional physiotherapy, it was reported that Lokomat is equally effective in terms of balance. Another review found that patients undergoing robot-assisted gait training showed better improvement in balance compared to those not receiving this treatment. The literature supports Lokomat's positive effects on both balance and walking.
In this research, virtual reality applications on Lokomat® will be integrated as part of the exercises in the Lokomat group and virtual reality-based balance training using the Balance Trainer will be employed for the Balance-Trainer group.
Patients will be allocated to the Lokomat and Balance-Trainer groups based on the treatment they receive. Both systems are actively used in the hospital, which research conduct, for the purpose of actively treating patients who meet the research criteria for improving balance and walking in stroke survivors. Participants will engage in exercises with Lokomat® or Balance Trainer for three weeks, five sessions per week, each session lasting 30 minutes, totaling 15 sessions, in addition to their current rehabilitation program.
- Conditions
- Stroke
- Being tested
- Lokomat, Thera Trainer Balo, Person-Specific Rehabilitation Program
- Keywords
- Stroke, Virtual Reality, Lokomat, Thera-Trainer, Balance-Trainer, Robot Assisted Gait Training, Robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LokomatDevice
Robot Assisted Gait Training
Thera Trainer BaloDevice
Virtual Reality Based Balance Training Device
Person-Specific Rehabilitation ProgramOther
Person-Specific Rehabilitation Program
| Study group | Role | What they receive |
|---|---|---|
| Lokomat | Experimental | Not described Receives: Device: Lokomat; Other: Person-Specific Rehabilitation Program |
| Balance Trainer | Experimental | Not described Receives: Device: Thera Trainer Balo; Other: Person-Specific Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
This is a simple and safe balance test designed to measure an individual's ability to maintain balance while performing functional tasks. The person is asked to perform 14 tasks, and scores are given based on the completion of each task. A score of 0 is assigned when the activity is not performed at all, while a score of 4 is given when the activity is completed independently. The highest possible score is 56, with 0-20 indicating balance impairment, 21-40 suggesting an acceptable balance, and 41-56 indicating good balance.
Measured: Baseline and After last treatment seasion
Spatiotemporal Gait Analysis
In our research, spatiotemporal gait analysis will be conducted using the CMill VR+ device. As a result of gait analysis, parameters such as step lengths, swing, stance and double support phases, cadence, and levels of weight shifting to each side during walking will be recorded.
Measured: Baseline and After last treatment seasion
Secondary outcomes (2)
Functional Independence Measure
The Functional Independence Measure is a valid and reliable scale for assessing stroke patients, comprising 18 items that evaluate the patient both physically and cognitively. These items are primarily grouped under the headings of Self-Care, Sphincter Control, Transfer, Locomotion, Communication, and Social Cognition.
Measured: Baseline and After last treatment seasion
Functional Ambulation Category
It assesses the amount of physical support needed during walking, scoring from 0 to 5, with observations made through the assessment. The scoring is based on the amount of support the patient requires, ranging from 0 - indicating inability to ambulate independently and requiring maximum support, to 5 - defining a patient who can walk independently on all surfaces.
Measured: Baseline and After last treatment seasion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start12 Dec 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Akıncı, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164197
- Sponsor's protocol ID
- RAGT03
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Virtual Reality-Based Balance Training and Robot-Assisted Gait Training on Balance and Gait Performance in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT06164197
- Acronym / sponsor ID
- RAGT03
- Conditions
- Stroke
- Keywords
- Stroke, Virtual Reality, Lokomat, Thera-Trainer, Balance-Trainer, Robot Assisted Gait Training, Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Dec 2023 (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 aim of research is to examine and compare the effectiveness of virtual reality-based balance training and robot-assisted walking approaches on balance and gait in individuals post-stroke. Through the study, Investigators intend to reach conclusions regarding whether the focus should be on balance or walking training based on the Berg Balance Scale and Functional Ambulation Classification levels of stroke survivors. Subgroups will be formed in both groups based on Functional Ambulation and Berg Balance Scale scores. The balance and gait developments within these subgroups will be compared, aiming to determine at which levels balance or walking improvement is more pronounced. These findings are crucial for making the right choices in setting rehabilitation goals for individual patients.
Detailed description
Stroke is one of the leading causes of death in adults and results in severe disability. Within the first 3 months after a stroke, 20% of patients use a wheelchair, and 70% experience walking problems. Balance problems are among the most common issues after a stroke, impacting a patient's ability to sit, stand, transfer, and walk, thereby creating a risk of falls. Additionally, balance and walking quality are vital components, with abnormalities potentially leading to abnormal walking patterns, reduced walking speed, and spatiotemporal asymmetries. Therefore, improving balance and walking is a fundamental goal in stroke rehabilitation and holds priority for many patients and their families.
Robot-assisted gait training (RAGT) is an emerging and promising technological approach in stroke rehabilitation. RAGT provides safe, high-intensity, and task-oriented walking training with ample repetitions. Repetitive tasks can enhance neuroplasticity and motor learning, resulting in improved balance and walking speed.
Robotic systems come in two types: end-effector and exoskeleton. The Lokomat® FreeD (Hocoma AG, Switzerland) is an exoskeleton-type robot. Unlike the conventional Lokomat, the FreeD module allows pelvic translation to the right and left, along with rotation. These coordinated pelvic movements are mechanically facilitated by the device during walking. It is known that these movements are crucial for human walking and balance, and with the FreeD module, these pelvic movements have become part of robot-assisted gait training.
In a systematic review comparing Lokomat with conventional physiotherapy, it was reported that Lokomat is equally effective in terms of balance. Another review found that patients undergoing robot-assisted gait training showed better improvement in balance compared to those not receiving this treatment. The literature supports Lokomat's positive effects on both balance and walking.
In this research, virtual reality applications on Lokomat® will be integrated as part of the exercises in the Lokomat group and virtual reality-based balance training using the Balance Trainer will be employed for the Balance-Trainer group.
Patients will be allocated to the Lokomat and Balance-Trainer groups based on the treatment they receive. Both systems are actively used in the hospital, which research conduct, for the purpose of actively treating patients who meet the research criteria for improving balance and walking in stroke survivors. Participants will engage in exercises with Lokomat® or Balance Trainer for three weeks, five sessions per week, each session lasting 30 minutes, totaling 15 sessions, in addition to their current rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lokomat | Experimental | Device: Lokomat, Other: Person-Specific Rehabilitation Program |
| Balance Trainer | Experimental | Device: Thera Trainer Balo, Other: Person-Specific Rehabilitation Program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having the ICD-10 diagnosis code G.81 Hemiplegia
- At least 3 weeks having passed since the diagnosis (Subacute and cronic periods)
- Being 18 years of age or older
- Having a Berg Balance Score between 21-40 (indicating an acceptable balance)
- Being able to walk with or without support (FAC score of 2 or higher)
Key exclusion criteria (3 listed)
- Having a known additional neurological or orthopedic problem that could affect balance
- Inability to adapt to virtual reality applications in Lokomat and Balance Trainer
- Diagnosis being more than 2 years old
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 |
|---|---|---|
| LokomatRobot Assisted Gait Training | Device | Lokomat |
| Thera Trainer BaloVirtual Reality Based Balance Training Device | Device | Balance Trainer |
| Person-Specific Rehabilitation ProgramPerson-Specific Rehabilitation Program | Other | Balance Trainer, Lokomat |
Primary outcome
Berg Balance Scale
Time frame: Baseline and After last treatment seasion
This is a simple and safe balance test designed to measure an individual's ability to maintain balance while performing functional tasks. The person is asked to perform 14 tasks, and scores are given based on the completion of each task. A score of 0 is assigned when the activity is not performed at all, while a score of 4 is given when the activity is completed independently. The highest possible score is 56, with 0-20 indicating balance impairment, 21-40 suggesting an acceptable balance, and 41-56 indicating good balance.
Spatiotemporal Gait Analysis
Time frame: Baseline and After last treatment seasion
In our research, spatiotemporal gait analysis will be conducted using the CMill VR+ device. As a result of gait analysis, parameters such as step lengths, swing, stance and double support phases, cadence, and levels of weight shifting to each side during walking will be recorded.
2 secondary outcomes
Functional Independence Measure
Time frame: Baseline and After last treatment seasion
Functional Ambulation Category
Time frame: Baseline and After last treatment seasion
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 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 Lokomat, Thera Trainer Balo and Person-Specific Rehabilitation Program in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 3 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 30 Oct 2026. 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 Turkey (Türkiye). 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?
Berg Balance Scale (time frame: Baseline and After last treatment seasion). 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?
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 30 Oct 2026.