Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy
NCT ID: NCT01146587
Last Updated: 2015-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
120 participants
INTERVENTIONAL
2010-08-31
2016-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
GangTrainer GT1
30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
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
Lokomat
30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
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
Conventional Physiotherapy
60 minutes of Conventional Physiotherapy every workday for 8 weeks
Interventions
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GangTrainer GT1
30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
Lokomat
30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
Conventional Physiotherapy
60 minutes of Conventional Physiotherapy every workday for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
79 Years
ALL
No
Sponsors
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Privatklinik Villa Melitta
OTHER
Hochzirl Hospital
OTHER
Krankenhaus Bozen
OTHER
Krankenhaus Brixen
OTHER
Krankenhaus Meran
OTHER
Krankenhaus Bruneck
OTHER
Claudiana Landesfachhochschule
OTHER
Research Department for Neurorehabilitation South Tyrol
OTHER
Responsible Party
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Principal Investigators
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Leopold Saltuari, MD PhD
Role: STUDY_DIRECTOR
Hochzirl Hospital
Andreas Waldner, MD
Role: PRINCIPAL_INVESTIGATOR
Privatklinik Villa Melitta
Christopher Tomelleri, MSc
Role: STUDY_CHAIR
Privatklinik Villa Melitta
Locations
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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
Countries
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References
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Kolominsky-Rabas PL, Heuschmann PU. [Incidence, etiology and long-term prognosis of stroke]. Fortschr Neurol Psychiatr. 2002 Dec;70(12):657-62. doi: 10.1055/s-2002-35857. German.
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. doi: 10.1016/s0003-9993(03)00361-7.
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.
Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig 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. doi: 10.1177/0269215506071281.
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. doi: 10.1177/1545968307310050. Epub 2007 Dec 11.
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. doi: 10.1093/ptj/64.1.35.
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. doi: 10.1161/01.str.32.4.973.
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
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. doi: 10.3109/03790799109166684.
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
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. doi: 10.1191/026921598666182531.
Related Links
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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
Other Identifiers
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GT-LK-PT
Identifier Type: -
Identifier Source: org_study_id
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