- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411664
Assessment of Trunk Control and Postural Instability in Patients With Various Neurological Disorders (Stroke, Parkinson, Sclerosis Multiplex) Using Objective Tools (TecnoBody ProKin Posturometry, 3D Motion Analysis)
Objective Examination of Postural Instability Caused by Neurological Diseases
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Somogy County
-
Kaposvár, Somogy County, Hungary, 7400
- Somogy County Kaposi Mor Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Exclusion criteria:
- 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
- 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
Inclusion criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: stroke instability group
Mapping 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. |
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. |
|
Experimental: Parkinson instability group
Mapping 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. |
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. |
|
Experimental: Multiple sclerosis instability group
Mapping 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posturometry
Time Frame: 3 weeks
|
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.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3D motion analysis
Time Frame: 3 weeks
|
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.
|
3 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: József Dr. Tollár, Somogy County Kaposi Mor Teaching Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Stroke
- Multiple Sclerosis
- Parkinson Disease
Other Study ID Numbers
- IG/1356-0/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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