Trial document




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  DRKS00015893

Trial Description

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Title

Effectiveness of a robot-assisted mirror therapy with the Gloreha

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Trial Acronym

RgSG-Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

There are very few therapy options for the severely affected arm. The aim of the study is to investigate wether an intensive robot-assisted mirror therapy training can help patients with aqcuired brain injury to improve their hand function. The robot-assisted therapy is compared with the conventionally mirror therapy. The group membership is decided by drawing lots. Three tests are used to measure the grasping ability. The therapy is carried out 3-5 times a week á 30 minutes. The tests take place before the first intervention, after the last training and 3 month later.

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Brief Summary in Scientific Language

The aim of the study is to investigate wether intensive robot-assisted mirror therapy training leads to a significantly improved grasping ability compared to conventional mirror therapy in patients with aqcuired brain injury. Furthermore the usibility will be investigated with a questionnaire. The control intervention is performed in addition to the standard rehabilitation treatment. The examinations of the patients take place at three appointments: Baseline V1, after the last intervention V2 and three month later V3. The recruitment period is 12 month. The intervention takes place 3-5 times per week á 30 minutes over a period of 3-5 weeks. At least 12 training units are included in the analysis.

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Organizational Data

  •   DRKS00015893
  •   2018/11/15
  •   [---]*
  •   no
  •   Approved
  •   Eth-29/18, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Arm paresis
  •   I61 -  Intracerebral haemorrhage
  •   I63 -  Cerebral infarction
  •   S06 -  Intracranial injury
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Interventions/Observational Groups

  •   Robot-assisted mirror therapy: the intervention takes place 3-5 times per week á 30 minutes over a period of 3-5 weeks.
  •   Mirror therapy: the intervention takes place 3-5 times per week á 30 minutes over a period of 3-5 weeks.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The grasping ability of the affected hand is examined at three points: Baseline V1, after the last intervention V2 and three month later. The assessments are the Fugl-Meyer Test, the Motricity Index and the Box & Block Test.

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Secondary Outcome

Patients and therapist survey on safety and usability measured by a questionnaire and the pain scale.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/11/22
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients with severe arm paresis to plegia;
Fugl-Meyer Score hand/finger <4; Ashworth Spasticity Index <3; at least mobile in a wheelchair; Patients is able to follow and implement the therapist's instructions.

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Exclusion Criteria

Contractures in shoulder, elbow, hand and finger joints; active rheumatism; botox injection in the last three months on the affected arm; neglect; severe edema; parallel participation in other studies

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Addresses

  • start of 1:1-Block address primary-sponsor
    • P.A.N. Zentrum im Fürst Donnersmarck-Haus
    • Mr.  Prof. Dr. med.  Stephan  Bamborschke 
    • Rauentaler Straße 32
    • 13465  Berlin
    • Germany
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    • P.A.N. Zentrum im Fürst Donnersmarck-Haus
    • Ms.  Mareike  Schrader 
    • Wildkanzelweg 28
    • 13465  Berlin
    • Germany
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    • P.A.N. Zentrum im Fürst Donnersmarck-Haus
    • Ms.  Mareike  Schrader 
    • Wildkanzelweg 28
    • 13465  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • P.A.N. Zentrum im Fürst Donnersmarck-Haus
    • Mr.  Prof. Dr. med.  Stephan  Bamborschke 
    • Rauentaler Straße 32
    • 13465  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.