galop: Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GangTrainer GT1 First supratentorial non ambulatory stroke patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12 weeks undergo robotic treatment with the Gangtrainer GT1 for 30 minutes of gross therapy time every workday for a 8 weeks period |
Device: GangTrainer GT1
30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
Other Names:
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| Experimental: Lokomat First supratentorial non ambulatory stroke patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12 weeks undergo robotic treatment with the Lokomat for 30 minutes of gross therapy time every workday for a 8 weeks period |
Device: Lokomat
30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
Other Names:
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| Active Comparator: Conventional Physiotherapy First supratentorial non ambulatory stroke patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12 weeks undergo a conventional physiokinetherapeutic treatment session for 30 minutes of gross therapy time every workday for a 8 weeks period |
Other: Conventional Physiotherapy
60 minutes of Conventional Physiotherapy every workday for 8 weeks
Other Names:
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Outcome Measures
Primary Outcome Measures
- Functional Ambulation Category (FAC) [after 8 weeks]
Secondary Outcome Measures
- Barthel Index (BI) [at week 1]
- Barthel Index (BI) [after 4 weeks]
- Barthel Index (BI) [after 8 weeks]
- Barthel Index (BI) [after 24 weeks]
- Rivermead Mobility Index (RMI) [at week 1]
- Rivermead Mobility Index (RMI) [after 4 weeks]
- Rivermead Mobility Index (RMI) [after 8 weeks]
- Rivermead Mobility Index (RMI) [after 24 weeks]
- 10 metres Walking Test [at week 1]
- 10 metres Walking Test [after 4 weeks]
- 10 metres Walking Test [after 8 weeks]
- 10 metres Walking Test [after 24 weeks]
- 6 Minutes Walking Test on the Floor [at week 1]
- 6 Minutes Walking Test on the Floor [after 4 weeks]
- 6 Minutes Walking Test on the Floor [after 8 weeks]
- 6 Minutes Walking Test on the Floor [after 24 weeks]
- 6 Minutes Walking Test on the Treadmill with Body Weight Support [at week 1]
- 6 Minutes Walking Test on the Treadmill with Body Weight Support [after 4 weeks]
- 6 Minutes Walking Test on the Treadmill with Body Weight Support [after 8 weeks]
- 6 Minutes Walking Test on the Treadmill with Body Weight Support [after 24 weeks]
- Medical Research Council (MRC) [at week 1]
- Medical Research Council (MRC) [after 4 weeks]
- Medical Research Council (MRC) [after 8 weeks]
- Medical Research Council (MRC) [after 24 weeks]
- Modified Ashworth Scale (mAS) [at week 1]
- Modified Ashworth Scale (mAS) [after 4 weeks]
- Modified Ashworth Scale (mAS) [after 8 weeks]
- Modified Ashworth Scale (mAS) [after 24 weeks]
- Rivermead Visual Gait Assessment (RVGA) [at week 1]
- Rivermead Visual Gait Assessment (RVGA) [after 8 weeks]
- Rivermead Visual Gait Assessment (RVGA) [after 24 weeks]
- EuroQol 5 Dimensions (EQ-5D) [at week 1]
- EuroQol 5 Dimensions (EQ-5D) [after 8 weeks]
- EuroQol 5 Dimensions (EQ-5D) [after 24 weeks]
- modified emory Functional Ambulation Profile (meFAP) [at week 1]
- modified emory Functional Ambulation Profile (meFAP) [after 4 weeks]
- modified emory Functional Ambulation Profile (meFAP) [after 8 weeks]
- modified emory Functional Ambulation Profile (meFAP) [after 24 weeks]
- Functional Ambulation Category (FAC) [at week 1]
- Functional Ambulation Category (FAC) [after 4 weeks]
- Functional Ambulation Category (FAC) [after 24 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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First supratentorial stroke (ischaemic, haemorrhagic or ICH) resulting in a hemiparesis
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Interval from stroke 3 - 12 weeks
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Non ambulatory (FAC < 3)
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Free sitting on bedside for 1 minute, both feet on the floor, ev. holding on bedside by hands
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Barthel Index 25 - 65
Exclusion Criteria:
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Unstable cardiovascular system (in case of doubt, only after approval by a internist)
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Manifested heart diseases like labile compensated cardiac insufficiency (NYHA III), angina pectoris, myocardial infarction 120 days before study onset, cardiomyopathy, severe cardiac arrhythmia
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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
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Severe cognitive dysfunction, which does not allow for comprehension of the aims of this study
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Severe neurological or orthopaedic diseases (like polio, Parkinson´s disease), which massively affect the mobility
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Deep vein thrombosis
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Severe osteoporosis
-
Malignant tumour diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hochzirl Hospital | Hochzirl | Tirol | Austria | 6170 |
| 2 | Claudiana Landesfachhochschule | Bozen | Südtirol | Italy | 39100 |
| 3 | Krankenhaus Bozen | Bozen | Südtirol | Italy | 39100 |
| 4 | Privatklinik Villa Melitta | Bozen | Südtirol | Italy | 39100 |
| 5 | Krankenhaus Brixen | Brixen | Südtirol | Italy | 39042 |
| 6 | Krankenhaus Bruneck | Bruneck | Südtirol | Italy | 39031 |
| 7 | Krankenhaus Meran | Meran | Südtirol | Italy | 39012 |
Sponsors and Collaborators
- Research Department for Neurorehabilitation South Tyrol
- Privatklinik Villa Melitta
- Hochzirl Hospital
- Krankenhaus Bozen
- Krankenhaus Brixen
- Krankenhaus Meran
- Krankenhaus Bruneck
- Claudiana Landesfachhochschule
Investigators
- Principal Investigator: Andreas Waldner, MD, Privatklinik Villa Melitta
- Study Chair: Christopher Tomelleri, MSc, Privatklinik Villa Melitta
- Study Director: Leopold Saltuari, MD PhD, Hochzirl Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Participating Centre for the interventions GangTrainer GT1 and Conventional Physiotherapy
- Participating Centre for the interventions Lokomat and Conventional Physiotherapy
- Participating Centre responsible for the blinded rating of the visual gait analysis
Publications
- Baer HR, Wolf SL. Modified emory functional ambulation profile: an outcome measure for the rehabilitation of poststroke gait dysfunction. Stroke. 2001 Apr;32(4):973-9.
- Barbeau H, Visintin M. Optimal outcomes obtained with body-weight support combined with treadmill training in stroke subjects. Arch Phys Med Rehabil. 2003 Oct;84(10):1458-65.
- Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7.
- Collen FM, Wade DT, Robb GF, Bradshaw CM. The Rivermead Mobility Index: a further development of the Rivermead Motor Assessment. Int Disabil Stud. 1991 Apr-Jun;13(2):50-4.
- Hidler J, Nichols D, Pelliccio M, Brady K, Campbell DD, Kahn JH, Hornby TG. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. 2009 Jan;23(1):5-13. doi: 10.1177/1545968308326632.
- Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40.
- Kolominsky-Rabas PL, Heuschmann PU. [Incidence, etiology and long-term prognosis of stroke]. Fortschr Neurol Psychiatr. 2002 Dec;70(12):657-62. German.
- Lord SE, Halligan PW, Wade DT. Visual gait analysis: the development of a clinical assessment and scale. Clin Rehabil. 1998 Apr;12(2):107-19.
- MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5.
- Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoölig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27.
- Regnaux JP, Saremi K, Marehbian J, Bussel B, Dobkin BH. An accelerometry-based comparison of 2 robotic assistive devices for treadmill training of gait. Neurorehabil Neural Repair. 2008 Jul-Aug;22(4):348-54. Epub 2007 Dec 11.
- GT-LK-PT