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Stroke, AcutegalopNCT01146587

Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy

A study testing GangTrainer GT1, Lokomat and Conventional Physiotherapy in people with Stroke, Acute, run by Research Department for Neurorehabilitation South Tyrol at 7 sites in 2 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Stroke, Acute
What is being tested?
GangTrainer GT1, Lokomat and Conventional Physiotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
7 sitesin 2 countries
Study dates
Aug 2010to Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Italy6 sites

  • Claudiana Landesfachhochschule

    Bolzano, Südtirol, 39100

  • Krankenhaus Bozen

    Bolzano, Südtirol, 39100

  • Privatklinik Villa Melitta

    Bolzano, Südtirol, 39100

  • Krankenhaus Brixen

    Brixen, Südtirol, 39042

  • Krankenhaus Bruneck

    Bruneck, Südtirol, 39031

  • Krankenhaus Meran

    Meran, Südtirol, 39012

Other trials in Italy

Austria1 site

  • Hochzirl Hospital

    Hochzirl, Tyrol, 6170

Other trials in Austria

About this study

Official title: Robot Assisted Therapy for Acute Stroke Patients: a Comparative Study of GangTrainer GT I, Lokomat System and Conventional Physiotherapy

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.

Read the 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.

Conditions
Stroke, Acute
Being tested
GangTrainer GT1, Lokomat, Conventional Physiotherapy
Keywords
Stroke, Robotics, Gait, Rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GangTrainer GT1Device

    Also called Group A

    30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks

  • LokomatDevice

    Also called Group B

    30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks

  • Conventional PhysiotherapyOther

    Also called Group C

    60 minutes of Conventional Physiotherapy every workday for 8 weeks

Study groups in NCT01146587
Study groupRoleWhat they receive
GangTrainer GT1ExperimentalFirst 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
Receives: Device: GangTrainer GT1
LokomatExperimentalFirst 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
Receives: Device: Lokomat
Conventional PhysiotherapyActive comparatorFirst 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
Receives: Other: Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Ambulation Category (FAC)

    Measured: after 8 weeks

Secondary outcomes (41)

  1. Barthel Index (BI)

    Measured: at week 1

  2. Barthel Index (BI)

    Measured: after 4 weeks

  3. Barthel Index (BI)

    Measured: after 8 weeks

  4. Barthel Index (BI)

    Measured: after 24 weeks

  5. Rivermead Mobility Index (RMI)

    Measured: at week 1

  6. Rivermead Mobility Index (RMI)

    Measured: after 4 weeks

  7. Rivermead Mobility Index (RMI)

    Measured: after 8 weeks

  8. Rivermead Mobility Index (RMI)

    Measured: after 24 weeks

  9. 10 metres Walking Test

    Measured: at week 1

  10. 10 metres Walking Test

    Measured: after 4 weeks

  11. 10 metres Walking Test

    Measured: after 8 weeks

  12. 10 metres Walking Test

    Measured: after 24 weeks

  13. 6 Minutes Walking Test on the Floor

    Measured: at week 1

  14. 6 Minutes Walking Test on the Floor

    Measured: after 4 weeks

  15. 6 Minutes Walking Test on the Floor

    Measured: after 8 weeks

  16. 6 Minutes Walking Test on the Floor

    Measured: after 24 weeks

  17. 6 Minutes Walking Test on the Treadmill with Body Weight Support

    Measured: at week 1

  18. 6 Minutes Walking Test on the Treadmill with Body Weight Support

    Measured: after 4 weeks

  19. 6 Minutes Walking Test on the Treadmill with Body Weight Support

    Measured: after 8 weeks

  20. 6 Minutes Walking Test on the Treadmill with Body Weight Support

    Measured: after 24 weeks

  21. Medical Research Council (MRC)

    Measured: at week 1

  22. Medical Research Council (MRC)

    Measured: after 4 weeks

  23. Medical Research Council (MRC)

    Measured: after 8 weeks

  24. Medical Research Council (MRC)

    Measured: after 24 weeks

  25. Modified Ashworth Scale (mAS)

    Measured: at week 1

  26. Modified Ashworth Scale (mAS)

    Measured: after 4 weeks

  27. Modified Ashworth Scale (mAS)

    Measured: after 8 weeks

  28. Modified Ashworth Scale (mAS)

    Measured: after 24 weeks

  29. Rivermead Visual Gait Assessment (RVGA)

    Measured: at week 1

  30. Rivermead Visual Gait Assessment (RVGA)

    Measured: after 8 weeks

  31. Rivermead Visual Gait Assessment (RVGA)

    Measured: after 24 weeks

  32. EuroQol 5 Dimensions (EQ-5D)

    Measured: at week 1

  33. EuroQol 5 Dimensions (EQ-5D)

    Measured: after 8 weeks

  34. EuroQol 5 Dimensions (EQ-5D)

    Measured: after 24 weeks

  35. modified emory Functional Ambulation Profile (meFAP)

    Measured: at week 1

  36. modified emory Functional Ambulation Profile (meFAP)

    Measured: after 4 weeks

  37. modified emory Functional Ambulation Profile (meFAP)

    Measured: after 8 weeks

  38. modified emory Functional Ambulation Profile (meFAP)

    Measured: after 24 weeks

  39. Functional Ambulation Category (FAC)

    Measured: at week 1

  40. Functional Ambulation Category (FAC)

    Measured: after 4 weeks

  41. Functional Ambulation Category (FAC)

    Measured: after 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionDec 2015 (estimated)
  4. Study completionFeb 2016 (estimated)

Why it stopped: GangTrainer GT1 is not state of the art anymore for the principal Invesigator

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01146587
Sponsor's protocol ID
GT-LK-PT
Acronym
galop
Status last verified
Jun 2015
First submitted
14 Jun 2010
Last updated
8 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12459947

  • 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.

    PubMed 14586912

  • 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.

    PubMed 19109447

  • 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.

    PubMed 17213237

  • 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.

    PubMed 18073325

  • 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.

    PubMed 6691052

  • 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.

    PubMed 11283399

  • MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

    PubMed 14258950

  • 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.

    PubMed 1836787

  • 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.

    PubMed 3809245

  • 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.

    PubMed 9619652

Questions about this trial

What is this clinical trial studying?

A study testing GangTrainer GT1, Lokomat and Conventional Physiotherapy in people with Stroke, Acute, run by Research Department for Neurorehabilitation South Tyrol at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Ambulation Category (FAC) (time frame: after 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01146587, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.

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