Cerebellar Ataxia, Spastic Paraplegia, Spinal Cord Injuries (Complete and Incomplete), Stroke
Conditions
Keywords
Spinal cord injury, Ataxia, Stroke, Spastic paraplegia, Altered gait pattern, Eksobionics, Robotic therapy
Brief summary
* Objective assesment of the feasibility of integrating the Ekso Bionics - Ekso NR device into outpatient care * Objective assesment of quality of life, functionality and clinical symptomps of patients with stroke, cerebellar ataxia, spinal cord injury, and spastic paraparesis * Comparison of measured data and follow-up of changes in relation to themselves and each other * Analyzing the effects of the exoskeleton among the patients * Assessing the safety, possible side effects and tolerability of the EksoNR
Interventions
DEVICEGait training with exoskeleton
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.
Sponsors
Somogy Megyei Kaposi Mór Teaching Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* confirmed diagnosis of spinal cord injury (at or below the C4 level) * having cerebellar ataxia diagnosis * confirmed spastic paraparesis * ischemic stroke
Exclusion criteria
* height below 150 cm or above 190 cm * body weight exceeded 100 kg * multiple strokes in medical history * systolic blood pressure less than 120 or higher than 160 mmHg * orthostatic hypotension * arotid artery stenosis * severe heart disease * hemophilia * traumatic brain injury * seizure disorder * untreated diabetes * abnormal electroencephalography * abnormal blood panel * use of sedatives * irregular medication use * severe aphasia (Western Aphasia Battery ≤ 25) * severe visual or hearing impairment * severe sensory dysfunction * severe orthopedic problems * alcoholism * drug use * smoking after diagnosis of stroke * unable to walk at least 10 m with or without assistance in 6 minutes * BBS score ≤ 32 * BI score ≤ 70 * current participation in individual or group exercise program outside of standard physical therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index (BI) | 4 weeks | Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency. |
| Functional Independence Measure (FIM) | 4 weeks | Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walk test (6MWT) | 4 weeks | Functional exercise capacity, scaling 0-800 meters. The more meters a patient achieves, the better their cardiopulmonary function. |
| EG-5D-5L | 4 weeks | Health-related quality of life, having 5 dimensions and 5 levels, plus a Visual Analogue Scale (EQ-VAS) |
| Timed Up and Go (TUG) | 4 weeks | Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling. |
| Berg Balance Scale (BBS) | 4 weeks | Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance. |
| Tinetti | 4 weeks | Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk. |
| WHO Quality of Life (WHOQOL) | 4 weeks | 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. |
| Walking Index for Spinal Cord Injury II. (WISCI II.) | 4 weeks | 21 - level ordinal scale scoring walking ability after SCI, from total depenence (0) to independent walking (20). |
Countries
Hungary
Contacts
PRINCIPAL_INVESTIGATORJózsef Dr. habil. Tollár
Somogy County Kaposi Mór Teaching Hospital
Outcome results
None listed