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

Primary Purpose

Stroke, Acute

Status
Suspended
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
GangTrainer GT1
Lokomat
Conventional Physiotherapy
Sponsored by
Research Department for Neurorehabilitation South Tyrol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Stroke, Robotics, Gait, Rehabilitation

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hochzirl Hospital
  • Claudiana Landesfachhochschule
  • Krankenhaus Bozen
  • Privatklinik Villa Melitta
  • Krankenhaus Brixen
  • Krankenhaus Bruneck
  • Krankenhaus Meran

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

GangTrainer GT1

Lokomat

Conventional Physiotherapy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Functional Ambulation Category (FAC)

Secondary Outcome Measures

Barthel Index (BI)
Barthel Index (BI)
Barthel Index (BI)
Barthel Index (BI)
Rivermead Mobility Index (RMI)
Rivermead Mobility Index (RMI)
Rivermead Mobility Index (RMI)
Rivermead Mobility Index (RMI)
10 metres Walking Test
10 metres Walking Test
10 metres Walking Test
10 metres Walking Test
6 Minutes Walking Test on the Floor
6 Minutes Walking Test on the Floor
6 Minutes Walking Test on the Floor
6 Minutes Walking Test on the Floor
6 Minutes Walking Test on the Treadmill with Body Weight Support
6 Minutes Walking Test on the Treadmill with Body Weight Support
6 Minutes Walking Test on the Treadmill with Body Weight Support
6 Minutes Walking Test on the Treadmill with Body Weight Support
Medical Research Council (MRC)
Medical Research Council (MRC)
Medical Research Council (MRC)
Medical Research Council (MRC)
Modified Ashworth Scale (mAS)
Modified Ashworth Scale (mAS)
Modified Ashworth Scale (mAS)
Modified Ashworth Scale (mAS)
Rivermead Visual Gait Assessment (RVGA)
Rivermead Visual Gait Assessment (RVGA)
Rivermead Visual Gait Assessment (RVGA)
EuroQol 5 Dimensions (EQ-5D)
EuroQol 5 Dimensions (EQ-5D)
EuroQol 5 Dimensions (EQ-5D)
modified emory Functional Ambulation Profile (meFAP)
modified emory Functional Ambulation Profile (meFAP)
modified emory Functional Ambulation Profile (meFAP)
modified emory Functional Ambulation Profile (meFAP)
Functional Ambulation Category (FAC)
Functional Ambulation Category (FAC)
Functional Ambulation Category (FAC)

Full Information

First Posted
June 14, 2010
Last Updated
June 4, 2015
Sponsor
Research Department for Neurorehabilitation South Tyrol
Collaborators
Privatklinik Villa Melitta, Hochzirl Hospital, Krankenhaus Bozen, Krankenhaus Brixen, Krankenhaus Meran, Krankenhaus Bruneck, Claudiana Landesfachhochschule
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1. Study Identification

Unique Protocol Identification Number
NCT01146587
Brief Title
Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy
Acronym
galop
Official Title
Robot Assisted Therapy for Acute Stroke Patients: a Comparative Study of GangTrainer GT I, Lokomat System and Conventional Physiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Suspended
Why Stopped
GangTrainer GT1 is not state of the art anymore for the principal Invesigator
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Department for Neurorehabilitation South Tyrol
Collaborators
Privatklinik Villa Melitta, Hochzirl Hospital, Krankenhaus Bozen, Krankenhaus Brixen, Krankenhaus Meran, Krankenhaus Bruneck, Claudiana Landesfachhochschule

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Stroke, Robotics, Gait, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GangTrainer GT1
Arm Type
Experimental
Arm Description
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
Arm Title
Lokomat
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional Physiotherapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
GangTrainer GT1
Other Intervention Name(s)
Group A
Intervention Description
30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
Intervention Type
Device
Intervention Name(s)
Lokomat
Other Intervention Name(s)
Group B
Intervention Description
30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Other Intervention Name(s)
Group C
Intervention Description
60 minutes of Conventional Physiotherapy every workday for 8 weeks
Primary Outcome Measure Information:
Title
Functional Ambulation Category (FAC)
Time Frame
after 8 weeks
Secondary Outcome Measure Information:
Title
Barthel Index (BI)
Time Frame
at week 1
Title
Barthel Index (BI)
Time Frame
after 4 weeks
Title
Barthel Index (BI)
Time Frame
after 8 weeks
Title
Barthel Index (BI)
Time Frame
after 24 weeks
Title
Rivermead Mobility Index (RMI)
Time Frame
at week 1
Title
Rivermead Mobility Index (RMI)
Time Frame
after 4 weeks
Title
Rivermead Mobility Index (RMI)
Time Frame
after 8 weeks
Title
Rivermead Mobility Index (RMI)
Time Frame
after 24 weeks
Title
10 metres Walking Test
Time Frame
at week 1
Title
10 metres Walking Test
Time Frame
after 4 weeks
Title
10 metres Walking Test
Time Frame
after 8 weeks
Title
10 metres Walking Test
Time Frame
after 24 weeks
Title
6 Minutes Walking Test on the Floor
Time Frame
at week 1
Title
6 Minutes Walking Test on the Floor
Time Frame
after 4 weeks
Title
6 Minutes Walking Test on the Floor
Time Frame
after 8 weeks
Title
6 Minutes Walking Test on the Floor
Time Frame
after 24 weeks
Title
6 Minutes Walking Test on the Treadmill with Body Weight Support
Time Frame
at week 1
Title
6 Minutes Walking Test on the Treadmill with Body Weight Support
Time Frame
after 4 weeks
Title
6 Minutes Walking Test on the Treadmill with Body Weight Support
Time Frame
after 8 weeks
Title
6 Minutes Walking Test on the Treadmill with Body Weight Support
Time Frame
after 24 weeks
Title
Medical Research Council (MRC)
Time Frame
at week 1
Title
Medical Research Council (MRC)
Time Frame
after 4 weeks
Title
Medical Research Council (MRC)
Time Frame
after 8 weeks
Title
Medical Research Council (MRC)
Time Frame
after 24 weeks
Title
Modified Ashworth Scale (mAS)
Time Frame
at week 1
Title
Modified Ashworth Scale (mAS)
Time Frame
after 4 weeks
Title
Modified Ashworth Scale (mAS)
Time Frame
after 8 weeks
Title
Modified Ashworth Scale (mAS)
Time Frame
after 24 weeks
Title
Rivermead Visual Gait Assessment (RVGA)
Time Frame
at week 1
Title
Rivermead Visual Gait Assessment (RVGA)
Time Frame
after 8 weeks
Title
Rivermead Visual Gait Assessment (RVGA)
Time Frame
after 24 weeks
Title
EuroQol 5 Dimensions (EQ-5D)
Time Frame
at week 1
Title
EuroQol 5 Dimensions (EQ-5D)
Time Frame
after 8 weeks
Title
EuroQol 5 Dimensions (EQ-5D)
Time Frame
after 24 weeks
Title
modified emory Functional Ambulation Profile (meFAP)
Time Frame
at week 1
Title
modified emory Functional Ambulation Profile (meFAP)
Time Frame
after 4 weeks
Title
modified emory Functional Ambulation Profile (meFAP)
Time Frame
after 8 weeks
Title
modified emory Functional Ambulation Profile (meFAP)
Time Frame
after 24 weeks
Title
Functional Ambulation Category (FAC)
Time Frame
at week 1
Title
Functional Ambulation Category (FAC)
Time Frame
after 4 weeks
Title
Functional Ambulation Category (FAC)
Time Frame
after 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Waldner, MD
Organizational Affiliation
Privatklinik Villa Melitta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Tomelleri, MSc
Organizational Affiliation
Privatklinik Villa Melitta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leopold Saltuari, MD PhD
Organizational Affiliation
Hochzirl Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hochzirl Hospital
City
Hochzirl
State/Province
Tirol
ZIP/Postal Code
6170
Country
Austria
Facility Name
Claudiana Landesfachhochschule
City
Bozen
State/Province
Südtirol
ZIP/Postal Code
39100
Country
Italy
Facility Name
Krankenhaus Bozen
City
Bozen
State/Province
Südtirol
ZIP/Postal Code
39100
Country
Italy
Facility Name
Privatklinik Villa Melitta
City
Bozen
State/Province
Südtirol
ZIP/Postal Code
39100
Country
Italy
Facility Name
Krankenhaus Brixen
City
Brixen
State/Province
Südtirol
ZIP/Postal Code
39042
Country
Italy
Facility Name
Krankenhaus Bruneck
City
Bruneck
State/Province
Südtirol
ZIP/Postal Code
39031
Country
Italy
Facility Name
Krankenhaus Meran
City
Meran
State/Province
Südtirol
ZIP/Postal Code
39012
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
12459947
Citation
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.
Results Reference
background
PubMed Identifier
14586912
Citation
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.
Results Reference
background
PubMed Identifier
19109447
Citation
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.
Results Reference
background
PubMed Identifier
17213237
Citation
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.
Results Reference
background
PubMed Identifier
18073325
Citation
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.
Results Reference
background
PubMed Identifier
6691052
Citation
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.
Results Reference
background
PubMed Identifier
11283399
Citation
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.
Results Reference
background
PubMed Identifier
14258950
Citation
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
Results Reference
background
PubMed Identifier
1836787
Citation
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.
Results Reference
background
PubMed Identifier
3809245
Citation
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.
Results Reference
background
PubMed Identifier
9619652
Citation
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.
Results Reference
background
Links:
URL
http://www.villamelitta.it
Description
Participating Centre for the interventions GangTrainer GT1 and Conventional Physiotherapy
URL
http://neuro-hochzirl.tilak.at
Description
Participating Centre for the interventions Lokomat and Conventional Physiotherapy
URL
http://www.claudiana.bz.it/
Description
Participating Centre responsible for the blinded rating of the visual gait analysis

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Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy

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