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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ekso Group | Active Comparator | Improving gait with the help of the Eksobionics EksoNR device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait training with exoskeleton | Device | EksoNR is a wearable, battery-powered bionic exoskeleton that enables individuals with neurological or muscular injuries, lower limb weakness, paralysis, or gait disorders to stand and walk on flat surfaces. The hip and knee joints are powered by motors, and all movements are performed either by the patient's specific movements or by using an external controller. The robot's functions can be adjusted to determine the level of assistance the device provides to the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure (FIM) | Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is. | 4 weeks |
| Barthel Index (BI) | Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (TUG) | Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling. | 4 weeks |
| Berg Balance Scale (BBS) | Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance. |
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| Name | Affiliation | Role |
|---|---|---|
| József Dr. habil. Tollár | Somogy County Kaposi Mór Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Somogy County Kaposi Mór Teaching Hospital | Kaposvár | Somogy County | 7400 | Hungary |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| D002524 | Cerebellar Ataxia |
| D010264 | Paraplegia |
| D001259 | Ataxia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 4 weeks |
| Tinetti | Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk. | 4 weeks |
| Walking Index for Spinal Cord Injury II. (WISCI II.) | 21 - level ordinal scale scoring walking ability after SCI, from total depenence (0) to independent walking (20). | 4 weeks |
| 6 minute walk test (6MWT) | Functional exercise capacity, scaling 0-800 meters. The more meters a patient achieves, the better their cardiopulmonary function. | 4 weeks |
| EG-5D-5L | Health-related quality of life, having 5 dimensions and 5 levels, plus a Visual Analogue Scale (EQ-VAS) | 4 weeks |
| WHO Quality of Life (WHOQOL) | Measuring quality of life, scoring involves rating items on a 1-5 Likert scale, then tranforming these raw scores into a 0-100 scale for four main domains (Physical Health, Psychological, Social Relationships, Environment). The higher the score, the better the quality of life is. | 4 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002526 | Cerebellar Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |