NCT01146587

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.

Trial Health

37
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

7 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

5.3 years

First QC Date

June 14, 2010

Last Update Submit

June 4, 2015

Conditions

Stroke, Acute

Keywords

StrokeRoboticsGaitRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Functional Ambulation Category (FAC)

    after 8 weeks

Secondary Outcomes (41)

  • 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

  • +36 more secondary outcomes

Study Arms (3)

GangTrainer GT1

EXPERIMENTAL

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

Lokomat

EXPERIMENTAL

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

Conventional Physiotherapy

ACTIVE COMPARATOR

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

Interventions

GangTrainer GT1DEVICE

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

Also known as: Group A
GangTrainer GT1
LokomatDEVICE

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

Also known as: Group B
Lokomat
Conventional PhysiotherapyOTHER

60 minutes of Conventional Physiotherapy every workday for 8 weeks

Also known as: Group C
Conventional Physiotherapy

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hochzirl Hospital

Hochzirl, Tyrol, 6170, Austria

Location

Claudiana Landesfachhochschule

Bolzano, Südtirol, 39100, Italy

Location

Krankenhaus Bozen

Bolzano, Südtirol, 39100, Italy

Location

Privatklinik Villa Melitta

Bolzano, Südtirol, 39100, Italy

Location

Krankenhaus Brixen

Brixen, Südtirol, 39042, Italy

Location

Krankenhaus Bruneck

Bruneck, Südtirol, 39031, Italy

Location

Krankenhaus Meran

Meran, Südtirol, 39012, Italy

Location

Related Publications (11)

  • 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.

    PMID: 12459947BACKGROUND

  • 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.

    PMID: 14586912BACKGROUND

  • 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.

    PMID: 19109447BACKGROUND

  • 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.

    PMID: 17213237BACKGROUND

  • 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.

    PMID: 18073325BACKGROUND

  • 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.

    PMID: 6691052BACKGROUND

  • 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.

    PMID: 11283399BACKGROUND

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

    PMID: 14258950BACKGROUND

  • 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.

    PMID: 1836787BACKGROUND

  • 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.

    PMID: 3809245BACKGROUND

  • 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.

    PMID: 9619652BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andreas Waldner, MD

    Privatklinik Villa Melitta

    PRINCIPAL INVESTIGATOR

  • Christopher Tomelleri, MSc

    Privatklinik Villa Melitta

    STUDY CHAIR

  • Leopold Saltuari, MD PhD

    Hochzirl Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 17, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

AU(1)IT(6)