I60 I61 I62 I63 I64
Conditions
Interventions
Group 1: Combination of robot-assisted gait training in patients in the subacute phase after stroke
45 minutes, 4 times per week, for 4 weeks and conventional physiotherapy
25 minutes, 2 times per week, for 4 weeks
Group 2: Combination of robot-assisted gait training in patients in the chronic phase after stroke
25 minutes, 2 times per week, for 4 weeks
Group 3: Conventional physiotherapy in patients in the subacute phase after stroke
45 minutes, 4 times per week, for 4 weeks and 25 minutes, 2 times per week, for 4 weeks
Group 4: Conventional physiotherapy in patients in the chronic phase after stroke
45 minutes, 4 times per week, for 4 weeks and 25 minutes, 2 times per week, for 4 weeks
Sponsors
Tyromotion GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Potential study participants must meet all listed inclusion criteria to be eligible for participating in this clinical investigation. Patients will be recruited into this clinical investigation if they have been diagnosed with a first-ever ischemic or haemorrhagic stroke in the (early and late) subacute phase (<6 months post stroke) or in the chronic phase (=6 months post stroke) (Bernhardt et al., 2017), have an impairment in walking according to the neurological exam assessed by a neurologist and a Functional Ambulation Categories (FAC) score of 0-4/5 (Wade, 1992). Patients with subacute, severe stroke who are non-ambulatory are eligible if they are able to sit unsupported (i.e., without holding onto supports such as the edge of the bed), with feet supported and can be verticalised for at least 1 hour twice a day. Stroke is diagnosed based on current criteria according to the S1 Guideline (2017) (Hennerici & Kern, 2017) or the S2e Guideline of the German Society of Neurology (2021) (Ringleb et al., 2021). Adult patients aged between 18 and 99 of female, male and diverse genders, of any ethnicity and German speaking verbally and written language will be included. Patients should be able to understand the patient information and study procedure and follow instructions (=21/30 points on the Mini Mental Status Test (MMST). Patients will only be included if they appear able to participate in this clinical investigation over its complete duration, which will be evaluated by the study PI.
Exclusion criteria
Exclusion criteria: Patients will be excluded from this clinical investigation if they meet any of the criteria listed as follows. - 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 - Psychiatric diseases impairing patients’ compliance ability - 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 - 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 - 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 - 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; females of childbearing age need to commit themselves to practice a reliable form of contraception (e.g., birth control pill, 3-monthly hormone injection, intrauterine device (IUD), contraceptive ring) for the duration of the clinical investigation Any changes or adjustments to medication that has an influence on the participant’s walking ability/functional performance will lead to the exclusion of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.1 Walking ability - Functional Ambulation Categories (FAC) 1.2 Basic activities of daily living (ADL) –Barthel Index (BI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Walking speed, assessed by the 10-Metre Walk Test (10MWT) 2. Walking distance, assessed by the 6-Minute Walk Test (6MWT) 3. Number of falls– falls log 4. Functional mobility – Rivermead Mobility Index (RMI); Timed Up and Go (TUG); in a subsample (N=30) additional assessments of trunk control will be performed: Trunk Impairment Scale (TIS); Balance Assessment in Sitting and Standing Positions (BASSP); Brunel Balance Assessment (BBA) and Modified Functional Reach Test (MFRT). 5. Fall-related self-efficacy - Falls Efficacy Scale- International Version (FES-I) 6. Health-related quality of life - 5-level EQ-5D version (EQ-5D-5L) and short form of Stroke Impact Scale (SF-SIS) 7. Fatigue - Fatigue Severity Scale (FSS) 8. Gait and gait support parameters (gait speed, walking distance, number of steps, step length) – measured by LEXO® only during the RAGT intervention as part of the clinical routine 9. Physical exertion during the (robot-assisted) gait training - Borg CR10, measured every 7-10 minutes during the intervention as part of the clinical routine 10. Acceptability of the intervention – Smiley Likert Scale | — |
Countries
Austria
Contacts
Public ContactIsabella Hotz
Reha Zentrum Münster
Outcome results
None listed