Effects of robot-assisted and conventional gait training on walking ability, basic activities of daily living, walking, functional mobility, falls related self-efficacy and quality of life in patients after stroke: a randomised controlled trial
- Conditions
- I60I61I62I63I64Subarachnoid haemorrhageIntracerebral haemorrhageOther nontraumatic intracranial haemorrhageCerebral infarctionStroke, not specified as haemorrhage or infarction
- Registration Number
- DRKS00029910
- Lead Sponsor
- Tyromotion GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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 State Examination (MMSE)) (Folstein et al., 1975). 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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.1 Walking ability - Functional Ambulation Categories (FAC)<br>1.2 Basic activities of daily living (ADL) –Barthel Index (BI)<br>
- Secondary Outcome Measures
Name Time Method