Trial document




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  DRKS00009990

Trial Description

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Title

Robot Training Assistance in Humerus Fracture –a Multicenter, Controlled, Randomized Interventional Trial.

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Trial Acronym

RASTA

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URL of the Trial

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Brief Summary in Lay Language

In this trial patients with humerus fracture are treated by assisting robot training in addition to
standardised physiotherapy in rehabilitation phase. Due to the additional treatment of the injured extremitiy with special tasks by the arm robot during three weeks the function and mobility of the upper arm should be improved compared to patients treated with physiotherapy alone.

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Brief Summary in Scientific Language

In this randomized, controlled, interventional study patients in rehabilitation after humerus fracture will be assessed.
The intervention group receives assistant training with an arm robot during three weeks compared to control group receiving standard physio/ ergotherapy.
Primary objective is functional outcome and mobility of the injured extremity measured by Dash score.


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Organizational Data

  •   DRKS00009990
  •   2016/02/02
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  •   yes
  •   Approved
  •   381/2015BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   S42.2 -  Fracture of upper end of humerus
  •   Humerus Fracture
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Interventions/Observational Groups

  •   Training with Armeo Spring arm robot 3-5x/week Duration about 1 hour for 3 weeks
  •   Standard physiotherapy for 3 weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Dash Score (modul1) three months after fracture
Test for Disabilites of Hand, shoulder, Arm
30 items regarding ability to perform activities of daily living

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Secondary Outcome

Change of Wolf-Motor-Function Test after Treatment (3 weeks)
A standardised function test that assesses 15 daily acitivities (eg. lifiting a can, folding a towel) regarding time, function, and quality of movement


Change of shoulder joint mobility (degrees measured with Goniometer) after Treatment (3 weeks)

Change of Hand power (kg measured with Dynamometer) after Treatment (3 weeks)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2016/02/15
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   66   Years
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Additional Inclusion Criteria

Fracture type classification AO 11
Age 35 - 66 years
fracture osteosynthesis stabile for movements

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Exclusion Criteria

limited cognition (short orientation Memory test >10)
pain during shoulder movement (>5 visual analogue scale)
limited visus (<20%)
limited Hearing ability (understanding of talking)
isolated Tuberkulum Majus fracture (AO 11 A1)
fractre with involvement of glenoid,
double fracture
Plexus injury or axillar nerv injury
cardial failure NYHA III-IV
chronic obstructive pulmonary disease III-IV
limided Walking ability ( use of crutches)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Berufsgenossenschaftliche Unfallklinik Murnau
    • Professor Küntscher Str. 8
    • 82418  Murnau
    • Germany
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    • Klinik für geriatrische RehabilitationRobert-Bosch- Krankenhaus
    • Mr.  Lars  Schwickert 
    • Auerbachstr. 110
    • 70376  Stuttgart
    • Germany
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    • Berufsgenossenschaftliche Unfallklinik Murnau
    • Ms.  Janina  Lackner 
    • Professor-Küntscher-Str. 8
    • 82418  Murnau
    • Germany
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    • Berufsgenossenschaftliche Unfallklinik Murnau
    • Ms.  Janina  Lackner 
    • Professor-Küntscher-Str. 8
    • 82418  Murnau
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche gesetzliche Unfallversicherung DGUV
    • Alte Heerstr. 111
    • 53757  St. Augustin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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