I60 I61 I62 I63 I64 G35 G20 G82 G11 G61 G12.2
Conditions
Interventions
Group 1: Robot-assisted gait training
45 minutes, 4 times per week for 4 weeks
Sponsors
Tyromotion GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 18-99 years, male, female and diverse gender, any ethnicity, first-ever ischemic or hemorrhagic stroke, multiple sclerosis (MS), Parkinson’s Disease (PD), a spastic para- or tetraplegia caused by any type of spinal cord lesion, mild to medium grade hereditary ataxia, acute or chronic inflammatory demyelinating polyneuropathy (e.g., GBS, CIDP) or a motoneuron disease (e.g., ALS). All patients must be in a clinically stable phase of their disease, patients with subacute, severe stroke who are non-ambulatory are eligible if they can be verticalised for at least 1 hour twice a day. Further inclusion criteria will be impairment in walking according to the neurological exam assessed by a neurologist and Functional Ambulation Categories (FAC) of 0-4, intact cognitive function as defined by a score of =24/30 points on the Mini Mental State Examination (MMSE) (Folstein et al., 1975) and German speaking verbally and written language.
Exclusion criteria
Exclusion criteria: Concomitant disease (such as malignant disease, other severe neurological, orthopaedic or psychiatric diseases, cardiac contraindications), acute, pronounced pain symptoms despite conventional pain therapy, joint contractures, joint arthrodesis or severe spasticity (stiff/immobile joint) in the area of the lower extremity, extremely disproportionate growth of the legs and/or spinal column, body weight of less than 15 kg or more than 180 kg, body height of less than 100 cm or more than 200 cm, insufficient compliance e.g., patients with a serious mental illness or severe neurosis, significant reduction in bone density (osteopenia or osteoporosis), increased risk of bone fracture, osseous or joint instability (non-consolidated fractures, osteogenesis imperfecta, unstable spinal column, pseudoarthrosis, hip, knee or ankle joint instability), cardiac contraindications, severe vascular diseases of the lower limbs, high-grade ataxia, skin lesions in areas which get in contact with the device or the harness system (decubitus); infections, skin ulcers, late effects of previous injuries, especially of the lower extremity, states of health preventing active rehabilitation (e.g., respiratory diseases, orthopaedic diseases, cognitive impairments restricting communication, aphasia, neuropsychological disorders, infections or inflammatory diseases, osteomyelitis), severe apraxia, severe osteoarthritis in the area of the joints of the lower extremity, risk of autonomic dysreflexia (AD) in patients with spinal cord injury (SCI) with neurological levels of TH6 or cranial, reduced compliance, uncooperative or (self)aggressive behavior, cardiac diseases, e.g., heart failure and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, circulatory disorders of the lower limbs, recent joint injury or endoprosthetics (e.g., total endoprosthetics, knee or hip joint replacement, reconstruction of the cruciate ligament or meniscus) with contraindicated ranges of movement or load limits, consolidated fractures in the area of the lower extremity within a period of 6 months after injury, insufficiently treated epilepsy, recently occurred seizures or increased risk of seizures, mechanical ventilation, lack of head control, long-term infusions (e.g., Baclofen pump, intrathecal pumps, PEG tube …) or stimulators (e.g., pacemakers, nerve stimulators), enterostomy/ostomy, sensory impairments of the lower extremities and the torso, especially reduced sensation of pain, pregnancy as assessed by a pregnancy test in women of childbearing age before enrolment into the study, an MS relapse or other disease exacerbation for any of the included diseases during the intervention period will lead to the exclusion of a participant from the study, any changes or adjustments to medication that has an influence on the participant’s walking ability/performance will lead to the exclusion of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility (as assessed by the recruitment, retention and adherence rates, a structured adverse events log, acceptance of the intervention, semi-structured observation during the intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Number of falls– falls log [ambulatory patients] 2 Walking ability - Functional Ambulation Categories (FAC) [ambulatory patients] 3 Walking speed - 10-Metre Walk Test (10MWT) [ambulatory patients; assessed in clinical routine] RAGT-Neur-1 4 Dynamic balance during walking - Functional Gait Assessment (FGA) [ambulatory patients] 5 Walking distance - 6-Minute Walk Test (6MWT) [ambulatory patients; assessed in clinical routine] 6 Functional mobility - Timed Up and Go test (TUG) [ambulatory patients] 7 Dynamic balance - Four-Square Step Test (FSST) [ambulatory patients] 8 Trunk movement - Trunk Control Test (TCT) [non-ambulatory patients] 9 Limits of stability with respect to trunk movement - Modified Functional Reach Test (MFRT) [non-ambulatory patients] 10 Fall-related self-confidence - Falls Efficacy Scale-International Version (FES-I) 11 Health-related quality of life - 5-level EQ-5D version (EQ-5D-5L) 12 Depression - Beck Depression Inventory, second edition (BDI-II) 13 Fatigue - Fatigue Severity Scale (FSS) 14 Goal achievement - Goal Attainment Scaling (GAS) 15 Gait parameters (gait speed, walking distance, number of steps and step length) – measured by LEXO® during the intervention as part of the clinical routine 16 Body weight and gait support (percentage of body weight support, percentage of active/passive gait modes) - measured by LEXO® during the intervention as part of the clinical routine | — |
Countries
Austria
Contacts
Public ContactBarbara Seebacher
Reha Zentrum Münster
Outcome results
None listed