Khalifa Acute Effects

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Andreas Sandner-Kiesling , MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01762371
First received: January 4, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention
Totally Ruptured Anterior Cruciate Ligament in the Knee
Other: Khalifa Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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).

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Laser Doppler-Flow [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Perfusion

  • NIRS [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Near infrared spectroscopy, Oxygen saturation

  • IR Thermography [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Infrared thermography, temperature

  • QST [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Quantitative sensoric testing, pain

  • HRV [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Heart rate variability, sympathicus/parasympathicus activation

  • EEG [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Electroencephalogram, brain waves

  • Knee function [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    IKDC Score KT-1000 test Clinical / physical examination

  • SportsScience [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Posturomed Motion capture proprioception muscle power range of motion

  • Blood [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Catecholamines endorphins standard blood parameters


Secondary Outcome Measures:
  • Questionnaire [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Different questions about pain, lifestyle, subjective parameters


Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 4, 2013
Last Updated: January 4, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
ACL
Knee
Ligament
Cruciate
Anterior

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014