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OpenTrials
Completed

NCT Number: NCT01762371

Khalifa Acute Effects

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sports Center of University Salzburg

Hallein, State of Salzburg, 5400, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Khalifa Therapy

Other

One hour of Khalifa's therapy which is specially applied pressure to the skin.

Primary outcomes

  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 outcomes

  1. Questionnaire

    Time frame: 1 hour

    Different questions about pain, lifestyle, subjective parameters

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Interdisciplinary Evaluation of Acute Effects From Khalifa's Therapy at Patients With Fully Ruptured Anterior Cruciate Ligament (ACL).

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 7, 2013
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.