Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy (galop)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01146587
Recruitment Status : Suspended (GangTrainer GT1 is not state of the art anymore for the principal Invesigator)
First Posted : June 17, 2010
Last Update Posted : June 8, 2015
Sponsor:
Collaborators:
Privatklinik Villa Melitta
Hochzirl Hospital
Krankenhaus Bozen
Krankenhaus Brixen
Krankenhaus Meran
Krankenhaus Bruneck
Claudiana Landesfachhochschule
Information provided by (Responsible Party):
Research Department for Neurorehabilitation South Tyrol

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
Stroke, Acute Device: GangTrainer GT1 Device: Lokomat Other: Conventional Physiotherapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robot Assisted Therapy for Acute Stroke Patients: a Comparative Study of GangTrainer GT I, Lokomat System and Conventional Physiotherapy
Study Start Date : August 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : February 2016

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 Name: Group A

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 Name: Group B

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 Name: Group C




Primary Outcome Measures :
  1. Functional Ambulation Category (FAC) [ Time Frame: after 8 weeks ]

Secondary Outcome Measures :
  1. Barthel Index (BI) [ Time Frame: at week 1 ]
  2. Barthel Index (BI) [ Time Frame: after 4 weeks ]
  3. Barthel Index (BI) [ Time Frame: after 8 weeks ]
  4. Barthel Index (BI) [ Time Frame: after 24 weeks ]
  5. Rivermead Mobility Index (RMI) [ Time Frame: at week 1 ]
  6. Rivermead Mobility Index (RMI) [ Time Frame: after 4 weeks ]
  7. Rivermead Mobility Index (RMI) [ Time Frame: after 8 weeks ]
  8. Rivermead Mobility Index (RMI) [ Time Frame: after 24 weeks ]
  9. 10 metres Walking Test [ Time Frame: at week 1 ]
  10. 10 metres Walking Test [ Time Frame: after 4 weeks ]
  11. 10 metres Walking Test [ Time Frame: after 8 weeks ]
  12. 10 metres Walking Test [ Time Frame: after 24 weeks ]
  13. 6 Minutes Walking Test on the Floor [ Time Frame: at week 1 ]
  14. 6 Minutes Walking Test on the Floor [ Time Frame: after 4 weeks ]
  15. 6 Minutes Walking Test on the Floor [ Time Frame: after 8 weeks ]
  16. 6 Minutes Walking Test on the Floor [ Time Frame: after 24 weeks ]
  17. 6 Minutes Walking Test on the Treadmill with Body Weight Support [ Time Frame: at week 1 ]
  18. 6 Minutes Walking Test on the Treadmill with Body Weight Support [ Time Frame: after 4 weeks ]
  19. 6 Minutes Walking Test on the Treadmill with Body Weight Support [ Time Frame: after 8 weeks ]
  20. 6 Minutes Walking Test on the Treadmill with Body Weight Support [ Time Frame: after 24 weeks ]
  21. Medical Research Council (MRC) [ Time Frame: at week 1 ]
  22. Medical Research Council (MRC) [ Time Frame: after 4 weeks ]
  23. Medical Research Council (MRC) [ Time Frame: after 8 weeks ]
  24. Medical Research Council (MRC) [ Time Frame: after 24 weeks ]
  25. Modified Ashworth Scale (mAS) [ Time Frame: at week 1 ]
  26. Modified Ashworth Scale (mAS) [ Time Frame: after 4 weeks ]
  27. Modified Ashworth Scale (mAS) [ Time Frame: after 8 weeks ]
  28. Modified Ashworth Scale (mAS) [ Time Frame: after 24 weeks ]
  29. Rivermead Visual Gait Assessment (RVGA) [ Time Frame: at week 1 ]
  30. Rivermead Visual Gait Assessment (RVGA) [ Time Frame: after 8 weeks ]
  31. Rivermead Visual Gait Assessment (RVGA) [ Time Frame: after 24 weeks ]
  32. EuroQol 5 Dimensions (EQ-5D) [ Time Frame: at week 1 ]
  33. EuroQol 5 Dimensions (EQ-5D) [ Time Frame: after 8 weeks ]
  34. EuroQol 5 Dimensions (EQ-5D) [ Time Frame: after 24 weeks ]
  35. modified emory Functional Ambulation Profile (meFAP) [ Time Frame: at week 1 ]
  36. modified emory Functional Ambulation Profile (meFAP) [ Time Frame: after 4 weeks ]
  37. modified emory Functional Ambulation Profile (meFAP) [ Time Frame: after 8 weeks ]
  38. modified emory Functional Ambulation Profile (meFAP) [ Time Frame: after 24 weeks ]
  39. Functional Ambulation Category (FAC) [ Time Frame: at week 1 ]
  40. Functional Ambulation Category (FAC) [ Time Frame: after 4 weeks ]
  41. Functional Ambulation Category (FAC) [ Time Frame: after 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146587


Locations
Layout table for location information
Austria
Hochzirl Hospital
Hochzirl, Tirol, Austria, 6170
Italy
Claudiana Landesfachhochschule
Bozen, Südtirol, Italy, 39100
Krankenhaus Bozen
Bozen, Südtirol, Italy, 39100
Privatklinik Villa Melitta
Bozen, Südtirol, Italy, 39100
Krankenhaus Brixen
Brixen, Südtirol, Italy, 39042
Krankenhaus Bruneck
Bruneck, Südtirol, Italy, 39031
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
Layout table for investigator information
Principal Investigator: Andreas Waldner, MD Privatklinik Villa Melitta
Study Chair: Christopher Tomelleri, MSc Privatklinik Villa Melitta
Study Director: Leopold Saltuari, MD PhD Hochzirl Hospital

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Research Department for Neurorehabilitation South Tyrol
ClinicalTrials.gov Identifier: NCT01146587    
Other Study ID Numbers: GT-LK-PT
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Research Department for Neurorehabilitation South Tyrol:
Stroke
Robotics
Gait
Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases