Trial document




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  DRKS00015115

Trial Description

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Title

Retrospective data analysis of the influence on hand function before and after hand rehabilitation

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This retrospective data analysis of functional and patient related parameters after hand injuries during rehabilitation shall be used to evaluate therapeutic methods of hand rehabilitation and establish further diagnostic and therapeutic procedures.
We want to measure the differences in hand function before and after the first three weeks of standard rehabilitation in comparison to the not-injured hand. Confounders for further interventional studies are supposed to be detected.
Moreover, the acquired data can be used in the field of quality management concerning rehabilitation of the hand.

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Brief Summary in Scientific Language

This retrospective data analysis of functional and patient related parameters after hand injuries during rehabilitation shall be used to evaluate therapeutic methods of hand rehabilitation and establish further diagnostic and therapeutic procedures.
We want to measure the differences in hand function before and after the first three weeks of standard rehabilitation in comparison to the not-injured hand. Confounders for further interventional studies are supposed to be detected.
Moreover, the acquired data can be used in the field of quality management concerning rehabilitation of the hand.

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Organizational Data

  •   DRKS00015115
  •   2018/08/10
  •   [---]*
  •   yes
  •   Approved
  •   38/18, Ethik-Kommission der Ärztekammer Sachsen-Anhalt Bezirksstelle Halle
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Secondary IDs

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

  •   M25.64 -  [generalization M25.6: Stiffness of joint, not elsewhere classified]
  •   S61.0 -  Open wound of finger(s) without damage to nail
  •   M25.69 -  [generalization M25.6: Stiffness of joint, not elsewhere classified]
  •   S69.8 -  Other specified injuries of wrist and hand
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Interventions/Observational Groups

  •   Retrospective Analysis of Data,
    non-interventional study,
    Evaluation of existing data from hand rehabilitation programme
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Characteristics

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

Insight in the measurable outcome of the function of the hand at different time points (at the beginning and at the end of the current standard therapy) as well as in comparison to the healthy hand for the detection of possible confounders.

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Secondary Outcome

Provision of data for later analysis and quality management in the field of hand rehabilitation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2018/09/01
  •   600
  •   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

All Patients who participated special handtherapeutic rehabilitation in 2015, 2016 or 2017 for at least three weeks.

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Exclusion Criteria

Patients with injuries of both hands,
Patients whose rehabilitation period exceeds the turn of the year 2014/2015 or 2017/2018

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Addresses

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    • BG Klinikum Bergmannstrost
    • Merseburger Straße 165
    • 06112  Halle
    • Germany
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    • BG Klinikum Halle BergmannstrostKlinik für Plastische und Handchirurgie / BVZ
    • Mr.  Prof. Dr. med.  Frank  Siemers 
    • Merseburger Straße 165
    • 06112  Halle / Saale
    • Germany
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    • BG Klinikum Halle BergmannstrostKlinik für Plastische und Handchirurgie / BVZ
    • Ms.  Dr. med.  Anita  Kestel 
    • Merseburger Straße 165
    • 06112  Halle / Saale
    • Germany
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Sources of Monetary or Material Support

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    • BG Klinikum Bergmannstrost
    • Merseburger Straße 165
    • 06112  Halle
    • 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.