Trial document




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  DRKS00010801

Trial Description

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Title

Efficacy of Hippotherapy during neurologic rehabilitation in patients with cranial trauma

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study is performed in patients with cerebral injury due to trauma. The patients perform neurologic rehabilitation and show deficiencies in body control.

The objective of the study is to assess the efficacy of hippotherapie regarding balance and body control. l

Primary endpoint is the change of berg balance scale after 4 weeks of therapy.

The study is randomized in a cross-over study design. Group 1 gets hippotherapy for 4 weeks followed by additional physiotherapy. Group 2 gets additional therapy for 4 weeks followed by hippotherapy.

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Brief Summary in Scientific Language

Assessment of efficacy of hippotherapy in patients with functional disorder due to cerebral trauma in neurologic rehabilitation.

Primary endpoint: Change of berg balance scale after 4 weeks of hippotherapy.

Hypothesis: Hippotherapy for 4 weeks during rehabilitation of patients with cerebral trauma improves Balance compared to standardized physiotherapy measures.

Multicenter, prospektive, randomized study in two treatment groups in cross-over design.

Group 1: Hippotherapy 2x/week for 30 minutes for 4 weeks followed by additional physiotherapy 2x/week for 4 weeks.

Group 2: Additional physiotherapy 2x/week for 30 minutes for 4 weeks followed by hippotherapy 2x/week for 4 weeks.

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Organizational Data

  •   DRKS00010801
  •   2016/07/06
  •   [---]*
  •   yes
  •   Approved
  •   16025, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   S06.9 -  Intracranial injury, unspecified
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Interventions/Observational Groups

  •   Hippotherapy 2x/week for 30 minutes for 4 weeks followed by additional physiotherapy 2x/week for 30 minutes for 4 weeks
  •   Additional physiotherapy 2x/week for 30 minutes (in addition to standardized physical Training) for 4 weeks followed by hippotherapy 2x/week for 30 minutes for 4 weeks
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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
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Improvement of Berg Balance Scale after 4 weeks of hippotherapy

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Secondary Outcome

Improvement of Trunc Impairment Scale after 4 weeks of therapy

Improvement of mental situation (VAS)

adverse events

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • other 
  • Medical Center 
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Recruitment

  •   Planned
  •   2016/08/01
  •   20
  •   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

Age 18 years or more
Trunc impairment due to cerebral trauma (Trunc Impairment Scale 20 or lower)
informed consent

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Exclusion Criteria

persistent neurological movement disorder

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Addresses

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    • Berufsgenossenschaftliche Unfallklinik Murnau
    • Professor Küntscher Str. 8
    • 82418  Murnau
    • Germany
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    • Berufsgenossenschaftliche Unfallklinik Murnau
    • Ms.  Dr. med  Silke  Keiser 
    • Prof. Küntscher Str. 8
    • 82418  Murnau
    • Germany
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    • Berufsgenossenschaftliche Unfallklinik Murnau
    • Ms.  Dr. med  Silke  Keiser 
    • Prof. Küntscher Str. 8
    • 82418  Murnau
    • Germany
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Sources of Monetary or Material Support

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    • Berufsgenossenschaftliche Unfallklinik Murnau
    • Professor Küntscher Str. 8
    • 82418  Murnau
    • Germany
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Status

  •   Recruiting planned
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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.