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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
60 minutes of Conventional Physiotherapy every workday for 8 weeks
Hochzirl Hospital
Hochzirl, Tyrol, Austria
Claudiana Landesfachhochschule
Bolzano, Südtirol, Italy
Krankenhaus Bozen
Bolzano, Südtirol, Italy
Privatklinik Villa Melitta
Bolzano, Südtirol, Italy
Krankenhaus Brixen
Brixen, Südtirol, Italy
Krankenhaus Bruneck
Bruneck, Südtirol, Italy
Krankenhaus Meran
Meran, Südtirol, Italy
Functional Ambulation Category (FAC)
Time frame: after 8 weeks
Barthel Index (BI)
Time frame: at week 1
Barthel Index (BI)
Time frame: after 4 weeks
Barthel Index (BI)
Time frame: after 8 weeks
Barthel Index (BI)
Time frame: after 24 weeks
Rivermead Mobility Index (RMI)
Time frame: at week 1
Rivermead Mobility Index (RMI)
Time frame: after 4 weeks
Rivermead Mobility Index (RMI)
Time frame: after 8 weeks
Rivermead Mobility Index (RMI)
Time frame: after 24 weeks
10 metres Walking Test
Time frame: at week 1
10 metres Walking Test
Time frame: after 4 weeks
10 metres Walking Test
Time frame: after 8 weeks
10 metres Walking Test
Time frame: after 24 weeks
6 Minutes Walking Test on the Floor
Time frame: at week 1
6 Minutes Walking Test on the Floor
Time frame: after 4 weeks
6 Minutes Walking Test on the Floor
Time frame: after 8 weeks
6 Minutes Walking Test on the Floor
Time frame: after 24 weeks
6 Minutes Walking Test on the Treadmill with Body Weight Support
Time frame: at week 1
6 Minutes Walking Test on the Treadmill with Body Weight Support
Time frame: after 4 weeks
6 Minutes Walking Test on the Treadmill with Body Weight Support
Time frame: after 8 weeks
6 Minutes Walking Test on the Treadmill with Body Weight Support
Time frame: after 24 weeks
Medical Research Council (MRC)
Time frame: at week 1
Medical Research Council (MRC)
Time frame: after 4 weeks
Medical Research Council (MRC)
Time frame: after 8 weeks
Medical Research Council (MRC)
Time frame: after 24 weeks
Modified Ashworth Scale (mAS)
Time frame: at week 1
Modified Ashworth Scale (mAS)
Time frame: after 4 weeks
Modified Ashworth Scale (mAS)
Time frame: after 8 weeks
Modified Ashworth Scale (mAS)
Time frame: after 24 weeks
Rivermead Visual Gait Assessment (RVGA)
Time frame: at week 1
Rivermead Visual Gait Assessment (RVGA)
Time frame: after 8 weeks
Rivermead Visual Gait Assessment (RVGA)
Time frame: after 24 weeks
EuroQol 5 Dimensions (EQ-5D)
Time frame: at week 1
EuroQol 5 Dimensions (EQ-5D)
Time frame: after 8 weeks
EuroQol 5 Dimensions (EQ-5D)
Time frame: after 24 weeks
modified emory Functional Ambulation Profile (meFAP)
Time frame: at week 1
modified emory Functional Ambulation Profile (meFAP)
Time frame: after 4 weeks
modified emory Functional Ambulation Profile (meFAP)
Time frame: after 8 weeks
modified emory Functional Ambulation Profile (meFAP)
Time frame: after 24 weeks
Functional Ambulation Category (FAC)
Time frame: at week 1
Functional Ambulation Category (FAC)
Time frame: after 4 weeks
Functional Ambulation Category (FAC)
Time frame: after 24 weeks
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