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Khalifa Acute Effects

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ClinicalTrials.gov Identifier: NCT01762371
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Andreas Sandner-Kiesling , MD, Medical University of Graz

Brief Summary:
The primary hypothesis is that Khalifa's therapy has different acute effects in various organ systems i.e. proprioceptive, neuro-muscular, endogenous dopamine system, etc. These effects might indicate the pathway of the therapy.

Condition or disease Intervention/treatment Phase
Totally Ruptured Anterior Cruciate Ligament in the Knee Other: Khalifa Therapy Not Applicable

Detailed Description:
According to our previous study that evaluated the efficacy of Khalifa's therapy the investigators have seen that the therapy has acute effects which resulted in better knee function and later even in better healing of the ACL injury. This study should clear exactly which effects and pathways are involved in the therapy from multiple (interdisciplinary) point of views. Therefore the investigators will measure parameters that might be associated with this special technique directly before and after the therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Interdisciplinary Evaluation of Acute Effects From Khalifa's Therapy at Patients With Fully Ruptured Anterior Cruciate Ligament (ACL).
Study Start Date : December 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: K-Pat
Getting one time one hour of Khalifa's therapy for ACL injury treatment.
Other: Khalifa Therapy
One hour of Khalifa's therapy which is specially applied pressure to the skin.



Primary Outcome Measures :
  1. Laser Doppler-Flow [ Time Frame: 1 hour ]
    Perfusion

  2. NIRS [ Time Frame: 1 hour ]
    Near infrared spectroscopy, Oxygen saturation

  3. IR Thermography [ Time Frame: 1 hour ]
    Infrared thermography, temperature

  4. QST [ Time Frame: 1 hour ]
    Quantitative sensoric testing, pain

  5. HRV [ Time Frame: 1 hour ]
    Heart rate variability, sympathicus/parasympathicus activation

  6. EEG [ Time Frame: 1 hour ]
    Electroencephalogram, brain waves

  7. Knee function [ Time Frame: 1 hour ]
    IKDC Score KT-1000 test Clinical / physical examination

  8. SportsScience [ Time Frame: 2 hours ]
    Posturomed Motion capture proprioception muscle power range of motion

  9. Blood [ Time Frame: 1 hour ]
    Catecholamines endorphins standard blood parameters


Secondary Outcome Measures :
  1. Questionnaire [ Time Frame: 1 hour ]
    Different questions about pain, lifestyle, subjective parameters



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • totally ruptured ACL - MRI verified, 2 weeks old as a maximum
  • knee function: Any functional inhibition (stretching, bending or load)
  • BMI: 18-25
  • athletically active

Exclusion Criteria:

  • any surgical procedures at the injured knee at any previous time
  • any acute surgical indication
  • diabetes mellitus and/or high blood pressure
  • any permanent drug treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762371


Locations
Austria
Sports Center of University Salzburg
Hallein, Salzburg, Austria, 5400
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Andreas Kastner, MD AKH Linz
Principal Investigator: Andreas Sandner, MD Med Uni Graz

Responsible Party: Andreas Sandner-Kiesling , MD, Univ.Prof.Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01762371     History of Changes
Other Study ID Numbers: KhalSbg1
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Andreas Sandner-Kiesling , MD, Medical University of Graz:
ACL
Knee
Ligament
Cruciate
Anterior

Additional relevant MeSH terms:
Rupture
Wounds and Injuries