Trial document




This trial has been registered retrospectively.
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  DRKS00009979

Trial Description

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Title

Evaluation of the influence of active controlled motion (ACM) after operatively treated ankle fractures type Weber-B and -C with the necessity for partial weightbearing for 6 weeks

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Up to now there is almost no information about proprioceptive deficits after ankle fractures and their role in the rehabilitation process. However, it is known that in the knee joint there is no correlation between mechanical and subjective instability after rupture of the anterior cruciate ligament (ACL) but between proprioception and subjective instability and active controlled motion can decrease the proprioceptive deficit.Proprioceptive training of ankle fractures is commonly done with balance boards or balance circles. In patients with need of partial weightbearing this is not possible until full weightbearing is allowed. The aim of this study was to look for possible beneficial rehabilitation effects in the use of active controlled motion after operatively treated unstable ankle fractures with the need of partial weightbearing in the first six postoperative weeks.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009979
  •   2016/02/02
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  •   yes
  •   Approved
  •   159/10, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

  •   U1111-1179-0173 
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Health Condition or Problem studied

  •   S82.6 -  Fracture of lateral malleolus
  •   S82.8 -  Fractures of other parts of lower leg
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Interventions/Observational Groups

  •   physiotherapy 2-3 times/weeks for 6 weeks postoperatively
  •   physiotherapy 2-3 times/weeks plus additional exercise 20 minutes a day with an active controlled motion device for 6 weeks postoperatively
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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
  •   I
  •   N/A
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Primary Outcome

Range of motion of the ankle joint after 6 weeks

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Secondary Outcome

Range of motion of the ankle joint after 12 weeks; Range of motion of the subtalar joint after 6 and 12 weeks; changes in gait patterns after 6 and 12 weeks, results in questionnaires VAS FA, AOFAS, Mazur Score, Phillip-Score; Return to work

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/11/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Operatively treated unstable ankle fractures type B- or C in the Weber classification between 01.11.2010-30.09.2011 with the need of partial weightbearing for six weeks as the only injury, age over 18 years, possibility to perform active controlled motion and no problems in walking before the injury; verbal and written consent to participate in the study

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Exclusion Criteria

psychiatric comorbidities; unable to perform partial weightbearing

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Addresses

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    • Universitätsklinikum Würzburg
    • Josef-Schneider-Str.
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum Würzburg
    • Mr.  PD Dr.  Hendrik  Jansen 
    • Josef-Schneider-Str.
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum Würzburg
    • Mr.  PD Dr. med.  Hendrik  Jansen 
    • Josef-Schneider-Str.
    • 97080  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Würzburg
    • Josef-Schneider-Str.
    • 97080  Würzburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/01/10
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Trial Publications, Results and other Documents

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