Trial document





This trial has been registered retrospectively.
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  DRKS00018681

Trial Description

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Title

Evaluation of a Robotic Device for Rapid Assessment of Hand Sensorimotor Function

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Trial Acronym

ETH MIKE Reliability Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to investigate how hand movements and hand sensation can be measured with a robot. For this purpose, movements of the index finger are performed under various conditions. Our long-term goal is to understand how such deficits affect motor recovery after a stroke and whether these deficits can be reduced by personalized therapy.

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Brief Summary in Scientific Language

There is growing evidence that somatosensory impairment – especially proprioceptive dysfunction – results in a poor prognosis of functional recovery in neurological patients (e.g., after stroke). Nevertheless, proprioceptive impairment has received little attention in research and conventional clinical rehabilitation after stroke, which have a strong focus on motor training. Yet, proprioceptive function plays a critical role in grasping and manipulating objects and is thereby key for the functional independence of neurological patients. One major impediment for advancing the field of somatosensory rehabilitation may stem from the limited application and shortcomings of clinical assessments of somatosensory function, especially proprioception.
We have developed a new robotic device for a detailed assessment of proprioceptive, motor, and combined sensorimotor function of the hand. The ETH MIKE (Motor Impairment and Kinesthetic Evaluation) robot can provide well-controlled passive movement stimuli to the index finger metacarpophalangeal (MCP) joint in a standardized, automated way (e.g., for somatosensory assessment) and can render different haptic environments for an active interaction with the user (e.g., for motor assessments). This robotic platform provides a tool to investigate proprioceptive function and its link to motor and sensorimotor function.
The aim of this study is to examine the feasibility and reliability of a battery of robot-assisted assessments of hand function. The study will include stroke subjects with a wide range of hand disabilities. The subjects will be tested on two days, separated by 48 hours. The hypothesis is that the results of the robotic assessment will be comparable between those two measurements for each subject, meaning that the robotic outcome measures are reliable.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The data collected in this study are available upon reasonable request and under consideration of the ethical regulations

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Organizational Data

  •   DRKS00018681
  •   2019/09/26
  •   [---]*
  •   yes
  •   Approved
  •   F-2016-126, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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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

  •   The hand function of stroke patients will be assessed using a robotic device (involving exercises such as maximum force generation, fast finger movements). The assessment will be performed on two different days, with 48 hours break in between.
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Characteristics

  •   Non-interventional
  •   Other
  •   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

Robotic outcome measures (i.e. index finger velocity, position, force)

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Secondary Outcome

Clinical outcomes: Box & Block test, Nottingham Sensory Assessment, Montreal Cognitive Assessment, Fugl-Meyer Assessment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/08/26
  •   36
  •   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

Diagnosis of stroke (ischemic or hemorrhagic)

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Exclusion Criteria

Complete paralysis, pain when placing the hand in the device, inability to understand task instructions , minimum passive range of motion of MCP joint smaller than 20 degrees, maximum 40% of subjects (12/30) with unimpaired proprioception (Kinesthetic Up-Down Test KUDT in Nottingham Sensory Assessment 3/3), maximum 40% of subjects (12/30) with severely impaired proprioception (KUDT: 0/3), severe spasticity for finger flexors (Modified Ashworth Scale > 2)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Kliniken Schmieder Allensbach
    • Mr.  Prof. Dr. med.  Joachim  Liepert 
    • Zum Tafelholz 8
    • 78476  Allensbach
    • Germany
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    • ETH Zürich
    • Ms.  Monika  Zbytniewska 
    • Lengghalde 5, BAA RELab
    • 8092  Zurich
    • Switzerland
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    • ETH Zürich
    • Ms.  Monika  Zbytniewska 
    • Lengghalde 5, BAA RELab
    • 8092  Zurich
    • Switzerland
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Sources of Monetary or Material Support

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    • Schweizerischer Nationalfonds (SNF)Swiss National Science Foundation
    • Wildhainweg 3 Postfach
    • CH-3001  Bern
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2020/03/01
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Trial Publications, Results and other Documents

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