Stroke
Conditions
Keywords
stroke, robotic, virtual reality, augmented reality, rehabilitation, treadmill training
Brief 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. * 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.
Interventions
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.
OTHERRobot Assisted Treadmill Training
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.
OTHERTreadmill Training with Virtual and Augmented Reality
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.
OTHERCombined Treadmill Training
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.
Sponsors
Somogy Megyei Kaposi Mór Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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;
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 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index (BI) | 3 weeks | 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. |
| Functional Independence Measure scale (FIM) | 3 weeks | 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. |
| Berg Balance Scale (BBS) | 3 weeks | 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. |
| Tinetti test | 3 weeks | 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 |
| 6 minute walking test (6MWT) | 3 weeks | 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. |
| 10 meter walking test | 3 weeks | 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 |
| Posturographic examination | 3 weeks | 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. |
| 3D gait analysis - Spatiotemporal parameters | 3 weeks | 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). |
| 3D gait analysis - Spatial parameters | 3 weeks | 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). |
| 10. 3D gait analysis - Temporal parameters | 3 weeks | 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 (%). |
Countries
Hungary
Contacts
CONTACTNándor Prontvai
CONTACTJózsef Dr. habil. Tollár
PRINCIPAL_INVESTIGATORJózsef Dr. habil. Tollár
Somogy County Kaposi Mór Teaching Hospital
Outcome results
None listed