StrokeNCT07350798
Applicability of Robotic Devices, Virtual and Augmented Reality in the Rehabilitation of People With Stroke During Treadmill Training
A study testing High Intensity Training, Robot Assisted Treadmill Training and Treadmill Training with Virtual and Augmented Reality in people with Stroke, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
Objective assessment of clinical symptoms, mobility and quality of life changes resulting from stroke and determination of changes resulting from therapies. Assessment of the rehabilitation effectiveness of traditional high intensity training. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- High Intensity Training, Robot Assisted Treadmill Training and Treadmill Training with Virtual and Augmented Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHungary
- Study dates
- 1 Feb 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- has had a first ischemic stroke diagnosed by a neurologist based on CT or MRI;
- neurological examination shows mobility and postural limitations;
- mRS score of 2 or higher;
Who cannot join
- multiple strokes in the medical history;
- systolic blood pressure less than 120 or greater than 160 mmHg;
- orthostatic hypotension;
- carotid artery stenosis;
- severe heart disease;
- hemophilia;
Show all 25Show fewer
- traumatic brain injury;
- seizure disorder; untreated diabetes;
- abnormal electroencephalography;
- Mini Mental Test score < 22;
- abnormal blood panel;
- use of sedatives; irregular medication;
- severe aphasia (Western Aphasia Battery ≤ 25);
- severe vision or hearing impairment;
- severe sensory dysfunction;
- severe orthopedic problem;
- other neurological condition affecting motor function;
- alcoholism;
- drug use;
- smoking after stroke diagnosis;
- inability to walk at least 100 m with or without assistive devices in 6 minutes;
- BBS score ≤ 32;
- BI score ≤ 70;
- inability to understand verbal instructions or signals on a television screen;
- current participation in an individual or group exercise program outside of standard physiotherapy;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Somogy County Kaposi Mór Teaching Hospital
Kaposvár, Somogy County, 7400
Nándor Prontvai, +36309393367, prontvai.nandor@gmail.com
József Dr. habil. Tollár, +36306994497, tollarjozsef86@gmail.com
About this study
- Objective assessment of clinical symptoms, mobility and quality of life changes resulting from stroke and determination of changes resulting from therapies.
- Assessment of the rehabilitation effectiveness of traditional high intensity training.
- Assessment of the rehabilitation effectiveness of gait training performed on a treadmill with a robot-assisted soft-exoskeleton.
- Assessment of the rehabilitation effectiveness of treadmill training supplemented with virtual and augmented reality.
- Determination of the joint application possibilities of robot-assisted and virtual and augmented reality treadmill training in order to further increase the effectiveness.
- Comparison of the effectiveness of different trainings.
- Mapping of changes in gait patterns due to therapies using 3D motion analysis.
- Mapping of changes in postural stability due to therapies using posturography.
- Conditions
- Stroke
- Being tested
- High Intensity Training, Robot Assisted Treadmill Training, Treadmill Training with Virtual and Augmented Reality, Combined Treadmill Training
- Keywords
- stroke, robotic, virtual reality, augmented reality, rehabilitation, treadmill training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity TrainingOther
During HIT participants perform gait exercises, coordination tasks, balance exercises, posture improvement exercises and muscle strengthening with and without the use of various devices (Dynair cushion, Bosu, Pilates ball, weight ball, dead weight stick, TRX, coordination ladder and obstacles). This includes surface changes and changes of direction during the tasks, manipulation of the speed of the tasks and the use of height stimuli. The difficulty of the tasks is adjusted each time to the improving performance of the participants. The movements used here require a high level of attention and executive functions, as well as rapid cognitive processing speed to visual and auditory signals. The training provides strong neuromuscular stimulation due to the constantly changing sensory environment, such as soft/hard surface tasks, heavy/light tools, slow/fast movement execution, and reflexive/conscious reactions to external stimuli during the task. 5 times/week for 3 weeks, 45 minutes each.
Robot Assisted Treadmill TrainingOther
The R-TT group performs high-intensity treadmill training on a conventional treadmill. Before the training begins, the ReStore Soft exoskeleton, which is a special gait assist device, is fitted. The device uses motion sensors to process the movements of the lower limb on the healthy side and uses a motor attached to the waist to map them using bowden cables while walking on the affected paretic side in real time. During therapy, the amount of assistance provided by the exoskeleton can be continuously adjusted to the patient's needs from an external controller, so that therapy can be performed in a specialized manner for the individual. 5 times/week for 3 weeks, 45 minutes each.
Treadmill Training with Virtual and Augmented RealityOther
The VR\&AR-TT group performs treadmill training on a special treadmill, the C-Mill VR+ device, for which the virtual and augmented reality movement programs are provided by the CueFors 2.5 software, which is the original control software for the C-Mill. The C-Mill VR+ system is a 3 m long and 1 m wide treadmill with a force platform underneath. A 65" fixed-position monitor in front of the treadmill provides the virtual reality environment, and a projector placed next to the treadmill allows various tasks to be projected onto the treadmill belt, providing immediate real-time feedback to the patient and therapist via the force platform. 5 times/week for 3 weeks, 45 minutes each.
Combined Treadmill TrainingOther
Patients in the C-TT group use the ReStore Soft exoskeleton and the C-Mill VR+ system together. 5 times/week for 3 weeks, 45 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| HIT | Experimental | Receiving high intensity training Receives: Other: High Intensity Training |
| R-TT | Experimental | Receiving high intensity treadmill training with ReStore robotic device. Receives: Other: Robot Assisted Treadmill Training |
| VR&AR-TT | Experimental | Receiving treadmill training with C-Mill, a special treadmill that provides virtual and augmented reality. Receives: Other: Treadmill Training with Virtual and Augmented Reality |
| C-TT | Experimental | Receiving treadmill training with the combination of the ReStore and C-Mill system. Receives: Other: Combined Treadmill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) indicates the degree of independence in daily activities and the severity of disability. The method for assessing mRs is a guided interview. . The scoring is divided as follows: 0-No symptoms; 1-No significant disability. Able to carry out activities of daily living despite some symptoms; 2-Mild disability. Able to look after himself without assistance but not able to carry out all previous activities; 3-Moderate disability. Needs some assistance with activities of daily living but can walk without assistance; 4-Moderately severe disability. Unassisted, unable to meet his/her own physical needs, unable to walk without assistance; 5-Severe disability. Bedridden, incontinent, requires constant nursing care; 6-Dead
Measured: 3 weeks
Secondary outcomes (10)
Barthel Index (BI)
The Barthel Index (BI) is used to measure functional abilities, which sensitively measures the degree of independence and changes in it during various daily activities (eating, transfer movements to a wheelchair, personal toileting, toilet use, bathing, walking on level ground, climbing up and down stairs, dressing, defecation and urination) in cases of chronic, disabling diseases, especially in rehabilitation settings. The scoring method takes into account whether the assessed person receives assistance during the performance of the tasks. The scores of the individual items are added together and the resulting total score represents the BI result on a scale ranging from 0 to 100, the higher the score, the greater the independence.
Measured: 3 weeks
Functional Independence Measure scale (FIM)
Functional independence is measured using the Functional Independence Measure (FIM). The FIM is an 18-item scale that consists of motor and cognitive subscales. The assessment includes self-care, bladder control, toileting, mobility, communication, and cognitive functions. Each item is rated on a scale from 1 to 7, with 1 indicating maximum need for assistance and 7 indicating complete independence. Accordingly, the total scale score ranges from 18 to 126, with 18 indicating complete dependence and 126 indicating complete independence. Each subscale can be scored separately; in this study, the motor subscale of the FIM is also scored separately. In this case, the total scale can range from 13 to 91, with higher scores indicating greater motor independence.
Measured: 3 weeks
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) was used to measure static and dynamic balance. The BBS can objectively measure the subject's ability to balance safely during a series of pre-determined tasks. It is a 14-item task, with each item scored on a five-point scale from 0 to 4, where 0 indicates the lowest level of function and 4 the highest. The maximum score is 56, indicating perfect functional balance. A score below 45 indicates an increased risk of falling, and, the lower the score, the higher the risk of falling.
Measured: 3 weeks
Tinetti test
The Tinetti test is a common clinical tool for assessing mobility, balance (static and dynamic) and gait in the elderly, especially for assessing fall risk. Scoring: 0, 1, 2 points for each subscale. Total score 28. A score below 25 points significantly increases the likelihood of falling
Measured: 3 weeks
6 minute walking test (6MWT)
To measure endurance, we used a 6-minute walk test (6mWT). During the test, the subject walks back and forth along a pre-designated flat and straight 50 m long trail. The walk starts when the timer is started at the tester's command; the pace of the walk is set by the subject, with no interference from the tester. If the subject needs to stop for a rest during the walk, the timing is not stopped. The subject will continue walking for 6 min and will stop only at the direction of the examiner after the 6 min have elapsed. The result is the distance covered in 6 min, expressed in meters. If the subject is required to stop and sit down within the 6 min, the test result is the distance covered. The greater the distance traveled, the better the endurance required.
Measured: 3 weeks
10 meter walking test
A 10-meter walk test (10mWT) was used to measure walking speed. To perform the test, a 10 m long flat, level area was designated. The 10 m section was marked at 0, 2, 8 and 10 m with thick adhesive tape. The subject started walking at the 0 m mark on the instructions of the examiner. As soon as he reached the 2 m mark, the examiner started the timer and stopped it the moment he reached the 8 m mark, thus testing his walking speed over a 6 m stretch. The speed is given by the distance (6 m) divided by the time measured (in seconds to two decimal places) in m/s
Measured: 3 weeks
Posturographic examination
During the postural examination, the presence and extent of postural instability were monitored using a posturograph (ProKin 252N, TecnoBody, Dalmine, Italy). During the test, the subjects were asked to stand on the test apparatus for 20 s in 4 different in-creasingly difficult postures: 1-wide stance-eye open (WEO); 2-wide stance-eye closed (WEC); 3-narrow stance-eye open (NEO); 4-narrow stance-eye closed (NEC). During the test, the subjects stood barefoot on the test apparatus and were not exposed to any external stimuli during the test. The results are provided by the 3-dimensional path of the body's center of pressure (COP-Sway). The smaller the COP-Sway , the lower the postural instability.
Measured: 3 weeks
3D gait analysis - Spatiotemporal parameters
For 3D gait analysis we use the MVN Awinda motion capture system developed by Xsens (Movella, El Segundo, Califonia, US) and the MVN Analyze (version 2025.0.1.) motion analysis software. The MVN Awinda motion capture system consists of a total of 17 inertial measurement units (IMUs), which include accelerometers, gyroscopes, and magnetometers. The sensors are placed at different predefined anatomical points on the body.
The 3D gait analysis includes multiple distinct gait parameters, each representing an independent outcome with its own unit of measure. These parameters are not aggregated into a single composite score, but are analyzed and reported separately as standard spatiotemporal gait outcomes.
Spatiotemporal parameters: Gait speed (m/s); Number of steps (count); Cadence (steps/min).
Measured: 3 weeks
3D gait analysis - Spatial parameters
For 3D gait analysis we use the MVN Awinda motion capture system developed by Xsens (Movella, El Segundo, Califonia, US) and the MVN Analyze (version 2025.0.1.) motion analysis software. The MVN Awinda motion capture system consists of a total of 17 inertial measurement units (IMUs), which include accelerometers, gyroscopes, and magnetometers. The sensors are placed at different predefined anatomical points on the body.
The 3D gait analysis includes multiple distinct gait parameters, each representing an independent outcome with its own unit of measure. These parameters are not aggregated into a single composite score, but are analyzed and reported separately as standard spatiotemporal gait outcomes. Spatial parameters: Step length - Left (cm); Step length - Right (cm); Step length difference (cm); Step width - Left (cm); Step width - Right (cm); Step width difference (cm).
Measured: 3 weeks
10. 3D gait analysis - Temporal parameters
For 3D gait analysis we use the MVN Awinda motion capture system developed by Xsens (Movella, El Segundo, Califonia, US) and the MVN Analyze (version 2025.0.1.) motion analysis software. The MVN Awinda motion capture system consists of a total of 17 inertial measurement units (IMUs), which include accelerometers, gyroscopes, and magnetometers. The sensors are placed at different predefined anatomical points on the body. The 3D gait analysis includes multiple distinct gait parameters, each representing an independent outcome with its own unit of measure. These parameters are not aggregated into a single composite score, but are analyzed and reported separately as standard spatiotemporal gait outcomes. Temporal parameters (percentage of gait cycle): Total gait cycle - Left (%); Total gait cycle - Right (%); Swing phase - Left (%); Swing phase - Right (%); Stance phase - Left (%); Stance phase - Right (%); Double support phase - Left (%); Double support phase - Right (%).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Aug 2028 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
- Investigators
- József Dr. habil. Tollár, Principal investigator, Somogy County Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350798
- Sponsor's protocol ID
- IG/1357-0/2025
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of Robotic Devices, Virtual and Augmented Reality in the Rehabilitation of People With Stroke During Treadmill Training
- ClinicalTrials.gov ID
- NCT07350798
- Acronym / sponsor ID
- IG/1357-0/2025
- Conditions
- Stroke
- Keywords
- stroke, robotic, virtual reality, augmented reality, rehabilitation, treadmill training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 20 Jan 2026 (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.
- Objective assessment of clinical symptoms, mobility and quality of life changes resulting from stroke and determination of changes resulting from therapies.
- Assessment of the rehabilitation effectiveness of traditional high intensity training.
- Assessment of the rehabilitation effectiveness of gait training performed on a treadmill with a robot-assisted soft-exoskeleton.
- Assessment of the rehabilitation effectiveness of treadmill training supplemented with virtual and augmented reality.
- Determination of the joint application possibilities of robot-assisted and virtual and augmented reality treadmill training in order to further increase the effectiveness.
- Comparison of the effectiveness of different trainings.
- Mapping of changes in gait patterns due to therapies using 3D motion analysis.
- Mapping of changes in postural stability due to therapies using posturography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIT | Experimental | Other: High Intensity TrainingReceiving high intensity training |
| R-TT | Experimental | Other: Robot Assisted Treadmill TrainingReceiving high intensity treadmill training with ReStore robotic device. |
| VR&AR-TT | Experimental | Other: Treadmill Training with Virtual and Augmented RealityReceiving treadmill training with C-Mill, a special treadmill that provides virtual and augmented reality. |
| C-TT | Experimental | Other: Combined Treadmill TrainingReceiving treadmill training with the combination of the ReStore and C-Mill system. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- has had a first ischemic stroke diagnosed by a neurologist based on CT or MRI;
- neurological examination shows mobility and postural limitations;
- mRS score of 2 or higher;
Key exclusion criteria (25 listed)
- multiple strokes in the medical history;
- systolic blood pressure less than 120 or greater than 160 mmHg;
- orthostatic hypotension;
- carotid artery stenosis;
- severe heart disease;
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 |
|---|---|---|
| High Intensity TrainingDuring HIT participants perform gait exercises, coordination tasks, balance exercises, posture improvement exercises and muscle strengthening with and without the use of various devices (Dynair cushion, Bosu, Pilates ball, weight ball, dead weight stick, TRX, coordination ladder and obstacles). This includes surface changes and changes of direction during the tasks, manipulation of the speed of the tasks and the use of height stimuli. The difficulty of the tasks is adjusted each time to the improving performance of the participants. The movements used here require a high level of attention and executive functions, as well as rapid cognitive processing speed to visual and auditory signals. The training provides strong neuromuscular stimulation due to the constantly changing sensory environment, such as soft/hard surface tasks, heavy/light tools, slow/fast movement execution, and reflexive/conscious reactions to external stimuli during the task. 5 times/week for 3 weeks, 45 minutes each. | Other | HIT |
| Robot Assisted Treadmill TrainingThe R-TT group performs high-intensity treadmill training on a conventional treadmill. Before the training begins, the ReStore Soft exoskeleton, which is a special gait assist device, is fitted. The device uses motion sensors to process the movements of the lower limb on the healthy side and uses a motor attached to the waist to map them using bowden cables while walking on the affected paretic side in real time. During therapy, the amount of assistance provided by the exoskeleton can be continuously adjusted to the patient's needs from an external controller, so that therapy can be performed in a specialized manner for the individual. 5 times/week for 3 weeks, 45 minutes each. | Other | R-TT |
| Treadmill Training with Virtual and Augmented RealityThe VR\&AR-TT group performs treadmill training on a special treadmill, the C-Mill VR+ device, for which the virtual and augmented reality movement programs are provided by the CueFors 2.5 software, which is the original control software for the C-Mill. The C-Mill VR+ system is a 3 m long and 1 m wide treadmill with a force platform underneath. A 65" fixed-position monitor in front of the treadmill provides the virtual reality environment, and a projector placed next to the treadmill allows various tasks to be projected onto the treadmill belt, providing immediate real-time feedback to the patient and therapist via the force platform. 5 times/week for 3 weeks, 45 minutes each. | Other | VR&AR-TT |
| Combined Treadmill TrainingPatients in the C-TT group use the ReStore Soft exoskeleton and the C-Mill VR+ system together. 5 times/week for 3 weeks, 45 minutes each. | Other | C-TT |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 3 weeks
The modified Rankin Scale (mRS) indicates the degree of independence in daily activities and the severity of disability. The method for assessing mRs is a guided interview. . The scoring is divided as follows: 0-No symptoms; 1-No significant disability. Able to carry out activities of daily living despite some symptoms; 2-Mild disability. Able to look after himself without assistance but not able to carry out all previous activities; 3-Moderate disability. Needs some assistance with activities of daily living but can walk without assistance; 4-Moderately severe disability. Unassisted, unable to meet his/her own physical needs, unable to walk without assistance; 5-Severe disability. Bedridden, incontinent, requires constant nursing care; 6-Dead
10 secondary outcomes
Barthel Index (BI)
Time frame: 3 weeks
Functional Independence Measure scale (FIM)
Time frame: 3 weeks
Berg Balance Scale (BBS)
Time frame: 3 weeks
Tinetti test
Time frame: 3 weeks
6 minute walking test (6MWT)
Time frame: 3 weeks
10 meter walking test
Time frame: 3 weeks
Posturographic examination
Time frame: 3 weeks
3D gait analysis - Spatiotemporal parameters
Time frame: 3 weeks
3D gait analysis - Spatial parameters
Time frame: 3 weeks
10. 3D gait analysis - Temporal parameters
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- 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.
József Dr. habil. Tollár principal investigator
Somogy County Kaposi Mór Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Training, Robot Assisted Treadmill Training and Treadmill Training with Virtual and Augmented Reality in people with Stroke, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
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 25 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: looking for participants now, as of the sponsor's last update on 29 Jul 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 Hungary. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nándor Prontvai (+36303933367, prontvai.nandor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: 3 weeks). 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 29 Jul 2026.