Stroke, Acute
Conditions
Keywords
Stroke, Robotics, Gait, Rehabilitation
Brief summary
The GangTrainer GT I and the Lokomat have proven their effectiveness on stroke Patients, but a comparison on the same controlled study population has not been made so far. Aim of the study will not only be to establish which device will work better on acute, non ambulatory stroke Patients in terms of regain of gait ability and motor function, but also clinical matters, like the efficacy of the treatment period. As a result of the trial it should be highlighted which kind of therapy has to be suggested for Patients comparable to the study population. A significant better outcome of one device in regard to the other will suggest to use one device more than the other for future treatments.
Detailed description
A total of 120 Patients will be enroled in the study and divided into 2 treatment and 1 control group. Enroled Patients will all be first supratentorial non ambulatory stroke patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12 weeks. Theywill undergo either robotic treatment with the Gangtrainer GT1 or the Lokomat in one of the 2 treatment groups for 30 minutes of gross therapy time every workday for a 8 weeks period if they are in the treatment group, or conventional physiokinetherapy for 30 minutes of gross therapy time every workday for a 8 weeks period if they are in the control group. Primary outcome will be the Functional Ambulation Category (FAC) assessed at enrolment, after 4 weeks after 8 weeks and at 6 months follow up.
Interventions
DEVICEGangTrainer GT1
30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
DEVICELokomat
30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
OTHERConventional Physiotherapy
60 minutes of Conventional Physiotherapy every workday for 8 weeks
Sponsors
Privatklinik Villa Melitta
Hochzirl Hospital
Krankenhaus Bozen
Krankenhaus Brixen
Krankenhaus Meran
Krankenhaus Bruneck
Claudiana Landesfachhochschule
Research Department for Neurorehabilitation South Tyrol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* First supratentorial stroke (ischaemic, haemorrhagic or ICH) resulting in a hemiparesis * Interval from stroke 3 - 12 weeks * Non ambulatory (FAC \< 3) * Free sitting on bedside for 1 minute, both feet on the floor, ev. holding on bedside by hands * Barthel Index 25 - 65
Exclusion criteria
* Unstable cardiovascular system (in case of doubt, only after approval by a internist) * Manifested heart diseases like labile compensated cardiac insufficiency (NYHA III), angina pectoris, myocardial infarction 120 days before study onset, cardiomyopathy, severe cardiac arrhythmia * Severe joint misalignment (severe constriction of movement for hip, knee and/or ankle: more than 20° fixed hip and knee extension deficit, or more than 20° fixed plantar flexion of the ankle * Severe cognitive dysfunction, which does not allow for comprehension of the aims of this study * Severe neurological or orthopaedic diseases (like polio, Parkinson´s disease), which massively affect the mobility * Deep vein thrombosis * Severe osteoporosis * Malignant tumour diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Ambulation Category (FAC) | after 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Rivermead Mobility Index (RMI) | at week 1 |
| 10 metres Walking Test | at week 1 |
| 6 Minutes Walking Test on the Floor | at week 1 |
| 6 Minutes Walking Test on the Treadmill with Body Weight Support | at week 1 |
| Medical Research Council (MRC) | at week 1 |
| Barthel Index (BI) | at week 1 |
| Rivermead Visual Gait Assessment (RVGA) | at week 1 |
| EuroQol 5 Dimensions (EQ-5D) | at week 1 |
| modified emory Functional Ambulation Profile (meFAP) | at week 1 |
| Functional Ambulation Category (FAC) | at week 1 |
| Modified Ashworth Scale (mAS) | at week 1 |
Countries
Austria, Italy
Outcome results
None listed