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| Name | Class |
|---|---|
| Semmelweis University | OTHER |
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High-tech therapy, an innovative field of neurorehabilitation, has expanded rapidly in recent years. Advances in technology have enabled the use of devices that can assist with movement development from simple movements to more complex tasks.
This research investigates the effectiveness of rehabilitation programmes that complement robot-assisted therapy to help people relearn to walk in post-stroke rehabilitation. This would be measured in two variations, with the patient (in addition to a complex rehabilitation programme of conventional physiotherapy, occupational therapy, hydrotherapy, etc.) receiving either treadmill or no treadmill treatment. In both cases, the therapies will be carried out with advanced technology-based equipment (both treatments are part of the daily routine of the Institute's treatments, and the equipment will be used according to the instructions in the user manual), the C-Mill interactive robot-assisted device will be used for treadmill therapy, and the Andago robot-assisted device for non- treadmill therapy. There is no sharp distinction between the two systems. The inclusion and exclusion criteria are set so patients' conditions meet the indications for both devices, and patients eligible for treatment with one device are included in the other.
In our study, 80 patients will be selected.
The main objective of this research is to investigate the effectiveness of rehabilitation programmes in post-stroke rehabilitation using advanced technology-based therapy to assist in relearning walking. This will be measured in two variations: the patient will be randomly assigned (in addition to a complex rehabilitation programme of traditional physiotherapy, occupational therapy, hydrotherapy, etc.) to receive either treadmill treatment or no treadmill treatment. In both cases, the therapies are carried out using advanced technological equipment.
The investigators will enrol 80 people in our study. The comparison will be between 40 and 40 people, the main groups differing in terms of the type of advanced technology device used in the rehabilitation programme and whether they received treadmill or non-treadmill treatment. In total, they will participate in 20 sessions of therapy.
Furthermore, the investigators observe whether a greater change in condition can be measured in the early post-stroke period (0-3 months) or the late period (3 months-1 year) in specific parameters of the patient's gait. The time since the stroke provides an opportunity for subgroup analysis, but the number of cases limits this. This is significant because it is still an open question in the international literature regarding advanced technology-based therapy.
In all cases, the examination starts and ends with the DIERS motion analysis system, a light-optical scanning method based on VRS (Video Raster Stereography) and a sensor-equipped treadmill that allows the measurement of several parameters of gait and balancing ability. In addition, traditional physiotherapy assessment methods (Timed Up and Go, Berg Balance Test, 6-minute gait test, 10-metre gait test, Functional Independence Measure, Barthel) are used to assess gait pattern and self-sufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treadmill group | In both groups, using advanced technology-based tools (both treatments are part of the daily routine of the Institute's treatments and are used according to the instructions in the user manual), for the treadmill therapy, we use the C-Mill interactive high-tech device. |
| |
| Overground group | In both groups, we use an advanced technology-based device (both treatments are part of the daily routine of the Institute's treatments and are used according to the instructions in the user manual), and the Andago high-tech device for non-runner therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadmill training | Device | Therapy with treadmill-based advanced technology device. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Balancing skills | Berg Balance Test (values between 0-56, higher score means better outcome). | Through study completion, an average of 2 years. |
| Balancing skills | Timed Up and Go Test (how many seconds it takes the patient to complete the task). | Through study completion, an average of 2 years. |
| Balancing skills | Weight distribution (%) using the DIERS medical device. | Through study completion, an average of 2 years. |
| Balancing skills | COP movement (mm) using the DIERS medical device. | Through study completion, an average of 2 years. |
| Balancing skills | Sway area (mm2) using the DIERS medical device. | Through study completion, an average of 2 years. |
| Balancing skills | Romberg opened eyes, closed eyes (mm) using the DIERS medical device. | Through study completion, an average of 2 years. |
| Balancing skills | Strength of the lower limbs (hip extension, flexion, adduction and abduction) and the trunk (flexion, extension, rotation, lateroflexion) (N) using the DIERS medical device. | Through study completion, an average of 2 years. |
| Gait parameters |
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Inclusion Criteria:
Exclusion Criteria:
More than 1 year has passed since the stroke;
scores less than or equal to 3 on the Functional Ambulation Categories (FAC) scale;
patients who were unable to walk independently before the stroke;
patients treated with botulinum toxin in the lower limb in the last 3 months;
use of other lower limb advanced technology treatments during the study;
a person with limited capacity;
not physically able to bear weight;
severe aphasia (impairment of understanding or expression that severely impedes communication);
other condition that precludes the use of C-Mill or Andago:
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Patients of the National Institute for Medical Rehabilitation, Budapest, Hungary
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| Name | Affiliation | Role |
|---|---|---|
| Gábor Fazekas, MD, PhD | National Institute for Medical Rehabilitation, Hungary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Medical Rehabilitation | Budapest | Pest County | 1121 | Hungary |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Overground training |
| Device |
Therapy using an advanced technological device enables exercise on the ground. |
|
| DIERS | Device | The examination starts and ends with the DIERS motion analysis system, a light-optical scanning method based on VRS (Video Raster Stereography) and a sensor-equipped treadmill that allows the measurement of several parameters of gait and balancing ability. |
|
| Traditional physiotherapy assessments | Other | Traditional physiotherapy assessment methods (Timed Up and Go, Berg Balance Test, 6-minute gait test, 10-metre gait test, Functional Independence Measure, Barthel) are used to assess gait pattern and self-sufficiency. |
|
6-minute gait test (m). |
| Through study completion, an average of 2 years. |
| Gait parameters | 10-meter gait test (min). | Through study completion, an average of 2 years. |
| Gait parameters | step length (mm), using the DIERS medical device. | Through study completion, an average of 2 years. |
| Gait parameters | Step width (mm), using the DIERS medical device. | Through study completion, an average of 2 years. |
| Gait parameters | Heel strike (N), using the DIERS medical device. | Through study completion, an average of 2 years. |
| Gait parameters | COP movement (mm), using the DIERS medical device. | Through study completion, an average of 2 years. |
| Functional independence | Based on FIM (maximum 126 points, higher score means better outcome). | Through study completion, an average of 2 years. |
| Functional independence | Based on Barthel (values between 0-99, higher score means better outcome). | Through study completion, an average of 2 years. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |