Trial document




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  DRKS00015674

Trial Description

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Title

Development of a measurement setting and a gait cycle comparison and assessment procedure

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Trial Acronym

RTAE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to collect basic biomechanical data in "healthy" subjects and in stroke patients for further development of a robot-assisted gait trainer (end effector).

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Brief Summary in Scientific Language

This pilot study aims to collect and review the essential gait parameters that will be the basis for the implementation of an end-effector prototype to be developed in a collaborative project. An end-effector system which allows adaptation of the gait during walking and thus promotes the intrinsic activity of the patient does not exist yet to our knowledge. In order to develop accurate and tuned sensors, relevant biomechanical gait parameters for "normal" gait and stroke-impaired gait are collected in this pilot study. The pressure and force distribution, lower limb muscle activity and 2D joint kinematics are recorded and calculated using pressure sensors, EMG and reflective markers. Subsequently, the data of the healthy subjects are compared with the data of the stroke patients and will be used for developing the mechanics and sensors of an end-effector prototype.

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Organizational Data

  •   DRKS00015674
  •   2018/10/11
  •   [---]*
  •   yes
  •   Approved
  •   340/18, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   I64 -  Stroke, not specified as haemorrhage or infarction
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Interventions/Observational Groups

  •   Subjects and stroke patients perform an familiarization trail on the treadmill and then are asked to walk with slowly increasing speed of 0.5 km/h to max. 4 km/h for 45 seconds each on the treadmill. Subsequently, the data of the healthy subjects are compared with the data of the stroke patients and will be used for developing the mechanics and sensors of an end-effector prototype.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The participants and stroke patients will visit the lab for one testing session for the measurement of basic biomechanical data of kinetics, kinematics and electromyography of the lower extremities.
Primary outcome is the pressure distribution and the ground reaction force which are measured by pressure sensors in the instrumented treadmill. Further, the muscle activity of the tibialis anterior, gastrocnemius medialis, rectus femoris and biceps femoris is of interest and will be measured with surface electromyography.
The measured variables then serve to develop the comparison method of healthy participants with stroke patients.

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Secondary Outcome

The secondary outcome is the calculation of 2D joint angles of the lower limb by using reflective markers placed on points of articulation and video recordings. By using the software of Noraxon, the knee angles and ankle angles are tracked and calculated on the basis of the video recordings. The measurement takes place simultaneously with the measurement of the primary outcome.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/10/09
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Written consent of study participation, Patients after stroke in rehabilitation clinic with motor impairment of the lower limb (e.g., Wernicke-Mann gait, weak foot dorsiflexion)

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Exclusion Criteria

Lower limb injuries, Impairment by diagnosis Stroke: neglect, pusher syndrome, central balance disorder, ataxia, impaired vision, disturbed trunk stability

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Addresses

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    • Institut für rehabilitationsmedizinische Forschung an der Universität Ulm
    • Am Kurpark 1
    • 88422  Bad Buchau
    • Germany
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    • Institut für rehabilitationsmedizinsche Forschung an der Universität Ulm
    • Ms.  Christina  Kaltenbach 
    • Am Kurpark 1
    • 88422  Bad Buchau
    • Germany
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    • Institut für rehabilitationsmedizinsche Forschung an der Universität Ulm
    • Ms.  Christina  Kaltenbach 
    • Am Kurpark 1
    • 88422  Bad Buchau
    • Germany
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Sources of Monetary or Material Support

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    • AiF Projekt GmbH, Projektträger des Bundesministeriums für Wirtschaft und Energie (ZIM)
    • Tschaikowskistraße 49
    • 13156  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/03
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.