Khalifa Acute Effects

May 4, 2015 updated by: Andreas Sandner-Kiesling , MD, Medical University of Graz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Salzburg
      • Hallein, Salzburg, Austria, 5400
        • Sports Center of University Salzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laser Doppler-Flow
Time Frame: 1 hour
Perfusion
1 hour
NIRS
Time Frame: 1 hour
Near infrared spectroscopy, Oxygen saturation
1 hour
IR Thermography
Time Frame: 1 hour
Infrared thermography, temperature
1 hour
QST
Time Frame: 1 hour
Quantitative sensoric testing, pain
1 hour
HRV
Time Frame: 1 hour
Heart rate variability, sympathicus/parasympathicus activation
1 hour
EEG
Time Frame: 1 hour
Electroencephalogram, brain waves
1 hour
Knee function
Time Frame: 1 hour
IKDC Score KT-1000 test Clinical / physical examination
1 hour
SportsScience
Time Frame: 2 hours
Posturomed Motion capture proprioception muscle power range of motion
2 hours
Blood
Time Frame: 1 hour
Catecholamines endorphins standard blood parameters
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: 1 hour
Different questions about pain, lifestyle, subjective parameters
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Andreas Sandner, MD, Med Uni Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 4, 2013

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KhalSbg1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Totally Ruptured Anterior Cruciate Ligament in the Knee

Clinical Trials on Khalifa Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe