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StrokeNCT07411664

Objective Longitudinal Monitoring of Postural Stability and Gait During Neurorehabilitation: Clinical Application of Instrumented Posturography and Three-Dimensional Motion Analysis

A study testing Stroke posturo/3D group, Parkinson posturo/3D group and Multiple sclerosis posturo/3D group in people with Stroke and PARKINSON DISEASE (Disorder), run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Nowadays, stroke is one of the most common leading causes of death in many countries. As the number of stroke patients is increasing, even in younger age groups, there is an increasing need to improve their rehabilitation. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Stroke posturo/3D group, Parkinson posturo/3D group and Multiple sclerosis posturo/3D group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
1 siteHungary
Study dates
1 Mar 2026to 1 Mar 2027
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with a first-time stroke
  • or Parkinson's disease
  • or multiple sclerosis
  • diagnosed by CT or MRI scan by a neurologist
  • exclusively chronic patients
  • mobility and postural difficulties as determined by a modified Rankin scale score (≥ 2).

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 functions
  • current acute or subacute phase of the disease
  • alcoholism, drug use
  • smoking after stroke diagnosis
  • inability to understand verbal instructions or signals on a television screen
  • current participation in an individual or group exercise program in addition to standard physiotherapy
  • unable to walk at least 10 meters independently

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
  • Somogy County Kaposi Mór Teaching Hospital

    Kaposvár, Somogy County, 7400

Other trials in Hungary

About this study

Nowadays, stroke is one of the most common leading causes of death in many countries. As the number of stroke patients is increasing, even in younger age groups, there is an increasing need to improve their rehabilitation. In order for this process to start, it is inevitable to integrate the latest recommendations of health and sports science into rehabilitation, in addition to medicine, so that the treatment is as complex as possible. Parkinson's disease is one of the most common neurological diseases, in addition to stroke. The most significant damage can be experienced in motor functions, since one of the main symptoms of the disease is slowed movement, tremor and balance disorders. This postural change can lead to many other musculoskeletal changes, which is why Parkinson's disease is an extremely complex disease that also requires a complex treatment. The third disease examined in our research is multiple sclerosis (MS), which is also one of the most significant nervous system diseases, with nearly 1 million cases registered so far. The most common symptoms of MS patients are weakness, numbness, dizziness, coordination and balance disorders, as well as changes and uncertainty in the gait pattern. One of the essential foundations of rehabilitation after neurological diseases is neurorehabilitation, since the process will only be truly effective if cognitive and motor functions are developed in parallel. In the case of neurological diseases, as we can see above, one of the most significant symptoms is coordination and balance disorders. When the nervous system is affected, trunk control and the patient's posture will always change, depending on the given disease and the individual. One of the fundamental goals of rehabilitation should be to develop stability and postural control, because without these, we will not be able to effectively develop and restore the patients' significant motor functions. This is why it is important that neurological patients are assessed from this perspective as early as possible, so that their treatment plan can be adapted to their disease and themselves as much as possible.

Read the detailed description

Posturometry: The Tecnobody ProKin stabilometer and posturometer device is currently one of the most effective for objective measurement of static and dynamic balance. The device can be used for both neurological and orthopedic patients. It can effectively measure the trunk control and sense of balance of patients in several ways: on stable or unstable surfaces, and standing on one or two legs. With the help of various programs, the device determines the oscillations of the center of mass (CoP) of the given patient's body, and is able to accurately determine the patient's proprioceptive perception. Furthermore, ProKin can examine the joint movements of the trunk and lower limbs together or even separately. Thanks to these quantified data, we have the opportunity to map the postural instability and balance disorders caused by different patient groups, and thus we will be able to provide a more accurate treatment for our patients. The ProKin device is not only excellent for diagnosis, but also for training, as it contains numerous interactive programs with which we can improve these stability difficulties.

3D motion analysis: With the help of the 3D motion analysis system (Xsens 3D Motion Capture), we can track and record patients' gait patterns in real time. Sensors were used to measure stride length, stride width, and the number of steps taken over a distance of 10 meters.

Exercise program: Each of the selected participants will participate in a training program, which would essentially be a neurorehabilitation training combined with virtual therapy. A session for patients receiving virtual therapy would be structured as follows: 5 minutes of warm-up, 25 minutes of training, 25 minutes of VR, and 5 minutes of cool-down. The main focus of the warm-up is primarily on increasing circulation and introducing them to the workout. While walking or jogging, the patients perform various trunk and limb mobilization and strengthening exercises, first without equipment, and then with equipment (Pilates ball, ball stick, weight ball). The primary focus of the training is primarily on restoring motor functions, which we try to achieve with coordination and balance development exercises, posture correction tasks, and general muscle strengthening. During the exercises, we regularly modify the directions, surfaces, and height levels. These changes can improve both coordination and balance extremely effectively. We also modify the speed of completing the tasks within and between tasks (slow/fast movement execution, length of pause between tasks). The exercises are mostly performed with some kind of device (Dynair cushion, Bosu, Fitball, coordination ladder, barriers, TRX, ball stick, Pilates ball, weight ball). Patients exercise in various body positions, but most exercises are done while walking or standing. One of the most important parts of the training is the development of gait, for which we perform stabilizing exercises and tasks practicing different step patterns with the given modifications and devices. The difficulty of the tasks is adapted to the patient's daily workload and performance capacity each time. The majority of the tasks consist of complex and compound exercises. This neurorehabilitation training significantly improves the adaptability of the nervous system, as the constantly changing sensory stimuli strongly stimulate it, thus developing increasingly better and more precise movements. Another important aspect is the development of cognitive functions in conjunction with movements, since with this level of neuromuscular stimulation (e.g., repetition of complex exercises), these skills can also improve. To implement VR therapy (also known as exergaming), we use Microsoft Xbox 360 and Xbox Kinect devices. These devices are able to sense and record the individual's shape, then place it in a virtual space, and imitate the patient's specific movements. During the therapy, we select three different programs: Kinect Adventure - Reflex Ridge, Kinect Adventure - Space Pop, and Just Dance. The essence of the Reflex Ridge program is that the patient's avatar moves forward on a platform rolling on rails, while constantly having to avoid obstacles from different directions. The system gives more points if the patient manages to avoid as many obstacles as possible without error, and thus the patient's performance can be easily reviewed. The difficulty level can be adjusted according to the frequency of the obstacles appearing. The essence of the Kinect Adventure - Space Pop program is a little more complex, as the patient needs to be able to move better in space. In the game, the participant performs complex spatial coordination tasks by moving their arms up and down and stepping in all directions of the space, trying to collect as many objects as possible, after which they receive points. In this program, reaction time and the ability to quickly change direction will also be the essential task. The third program is Just Dance, where patients have to imitate the movements of the avatars seen on the screen to given music as accurately as possible. The combined use of acoustic and visual stimuli develops motor functions more effectively, so this program proves to be an excellent choice in the rehabilitation of neurological patients. The performance of patients can also be monitored in this program, as after each level the system ranks the precise execution of movements with points, as well as the connection of movements into a continuous one. The cool-down part includes light walking exercises combined with breathing exercises, as well as a stretch designed to relax larger muscle groups.

Data are expressed as mean (±SD). The normal distribution of variables is checked using the Kolmogorov-Smirnov and Shapiro-Wilk tests. Groups are compared at baseline using one-way parametric or Kruskal Wallis analysis of variance. The extent of changes within groups is checked using paired T-test or Wilcoxon test according to the result of the normality test. The results of the groups are interpreted as the difference between the post-intervention and baseline scores. Significant differences between groups are determined using one-way parametric or Kruskal Wallis analysis of variance in the results. Tukey's post hoc test is used to identify values less than p<0.05 between each group. To examine the effect size within groups, Cohen's d is used (very small, 0.01; small, 0.20; medium, 0.50; large, 0.80; very large, 1.20; huge, 2.00) to determine the size of the effects over time. The data are processed using Microsoft Excel and R software.

Being tested
Stroke posturo/3D group, Parkinson posturo/3D group, Multiple sclerosis posturo/3D group
Keywords
posturometry, neurorehabilitation, virtual therapy, 3D analysis
Medical subject headings
Stroke, Parkinson Disease, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stroke posturo/3D groupDevice

    The Tecnobody ProKin stabilometer and posturometer is currently one of the most effective tools for objectively measuring static and dynamic balance. It can effectively measure the trunk control and sense of balance of patients in several ways: on stable or unstable surfaces, and while standing on one or two legs. With the help of various programs, the device determines the oscillations of the center of mass (CoP) of the patient's body, and is able to accurately determine the patient's proprioceptive perception. Furthermore, ProKin is able to examine the joint movements of the trunk and lower limbs together or even separately. Thanks to these quantified data, we have the opportunity to map the postural instability and balance disorders caused by different patient groups, and thus we will be able to provide a more accurate treatment for our patients.

    With 3D motion analysis stride length, stride width and the number of steps in 10 meters were measured.

  • Parkinson posturo/3D groupDevice

    The Tecnobody ProKin stabilometer and posturometer is currently one of the most effective tools for objectively measuring static and dynamic balance. It can effectively measure the trunk control and sense of balance of patients in several ways: on stable or unstable surfaces, and while standing on one or two legs. With the help of various programs, the device determines the oscillations of the center of mass (CoP) of the patient's body, and is able to accurately determine the patient's proprioceptive perception. Furthermore, ProKin is able to examine the joint movements of the trunk and lower limbs together or even separately. Thanks to these quantified data, we have the opportunity to map the postural instability and balance disorders caused by different patient groups, and thus we will be able to provide a more accurate treatment for our patients.

    With 3D motion analysis stride length, stride width and the number of steps in 10 meters were measured.

  • Multiple sclerosis posturo/3D groupDevice

    The Tecnobody ProKin stabilometer and posturometer is currently one of the most effective tools for objectively measuring static and dynamic balance. It can effectively measure the trunk control and sense of balance of patients in several ways: on stable or unstable surfaces, and while standing on one or two legs. With the help of various programs, the device determines the oscillations of the center of mass (CoP) of the patient's body, and is able to accurately determine the patient's proprioceptive perception. Furthermore, ProKin is able to examine the joint movements of the trunk and lower limbs together or even separately. Thanks to these quantified data, we have the opportunity to map the postural instability and balance disorders caused by different patient groups, and thus we will be able to provide a more accurate treatment for our patients.

    With 3D motion analysis stride length, stride width and the number of steps in 10 meters were measured.

Study groups in NCT07411664
Study groupRoleWhat they receive
stroke instability groupExperimentalMapping of coordination, balance and gait pattern disorders caused by stroke. After diagnosis, introducing a neurorehabilitation exercise program that improves postural instability by supplementing virtual therapy with conventional balance and coordination exercises. Investigating the effectiveness of neurorehabilitation treatments through therapy. Changes in neurological status after intervention.
Receives: Device: Stroke posturo/3D group
Parkinson instability groupExperimentalMapping of coordination, balance and gait patterns disorders caused by Parkinson's disease. After diagnosis, introducing a neurorehabilitation exercise program that improves postural instability by supplementing virtual therapy with conventional balance and coordination exercises. Investigating the effectiveness of neurorehabilitation treatments through therapy. Changes in neurological status after intervention.
Receives: Device: Parkinson posturo/3D group
Multiple sclerosis instability groupExperimentalMapping of coordination, balance and gait patterns disorders caused by multiple sclerosis. After diagnosis, introducing a neurorehabilitation exercise program that improves postural instability by supplementing virtual therapy with conventional balance and coordination exercises. Investigating the effectiveness of neurorehabilitation treatments through therapy. Changes in neurological status after intervention.
Receives: Device: Multiple sclerosis posturo/3D group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Posturometry

    With Tecnobody's ProKin stabilometer and posturometer device static and dynamic balance can be measured. Using various programs, the device determines the center of mass (CoP) (mm2) of the patient's body and is able to accurately determine the patient's proprioceptive perception. Furthermore, ProKin can examine the joint movements of the trunk and lower limbs together or even separately.

    Measured: 3 weeks

Secondary outcomes (1)
  1. 3D motion analysis

    3D motion analysis: With the help of the 3D motion analysis system (Xsens 3D Motion Capture), we can track and record patients' gait patterns in real time. Sensors were used to measure stride length (cm), stride width (cm), and the number of steps taken over a distance of 10 meters.

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start1 Mar 2026
  3. Primary completion1 Jul 2026
  4. Study completion1 Mar 2027 (estimated)

Resources

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
Single group
Masking
None (open label)
Enrolment
151 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07411664
Sponsor's protocol ID
IG/1356-0/2025
Status last verified
Oct 2026
First submitted
18 Dec 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Stroke posturo/3D group, Parkinson posturo/3D group and Multiple sclerosis posturo/3D group in people with Stroke and PARKINSON DISEASE (Disorder), 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 6 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: enrolling by invitation, as of the sponsor's last update on 20 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 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?

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?

Posturometry (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 20 Oct 2026.

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