Totally Ruptured Anterior Cruciate Ligament in the KneeNCT01762371
Khalifa Acute Effects
A study testing Khalifa Therapy in people with Totally Ruptured Anterior Cruciate Ligament in the Knee, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- Totally Ruptured Anterior Cruciate Ligament in the Knee
- What is being tested?
- Khalifa Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Sports Center of University Salzburg
Hallein, State of Salzburg, 5400
About this study
Official title: 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.
Read the 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.
- Being tested
- Khalifa Therapy
- Keywords
- ACL, Knee, Ligament, Cruciate, Anterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Khalifa TherapyOther
One hour of Khalifa's therapy which is specially applied pressure to the skin.
| Study group | Role | What they receive |
|---|---|---|
| K-Pat | Experimental | Getting one time one hour of Khalifa's therapy for ACL injury treatment. Receives: Other: Khalifa Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser Doppler-Flow
Perfusion
Measured: 1 hour
NIRS
Near infrared spectroscopy, Oxygen saturation
Measured: 1 hour
IR Thermography
Infrared thermography, temperature
Measured: 1 hour
QST
Quantitative sensoric testing, pain
Measured: 1 hour
HRV
Heart rate variability, sympathicus/parasympathicus activation
Measured: 1 hour
EEG
Electroencephalogram, brain waves
Measured: 1 hour
Knee function
IKDC Score KT-1000 test Clinical / physical examination
Measured: 1 hour
SportsScience
Posturomed Motion capture proprioception muscle power range of motion
Measured: 2 hours
Blood
Catecholamines endorphins standard blood parameters
Measured: 1 hour
Secondary outcomes (1)
Questionnaire
Different questions about pain, lifestyle, subjective parameters
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Totally Ruptured Anterior Cruciate Ligament in the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Sandner-Kiesling , MD, Medical University of Graz
- Investigators
- Andreas Kastner, MD, Principal investigator, AKH LinzAndreas Sandner, MD, Principal investigator, Med Uni Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762371
- Sponsor's protocol ID
- KhalSbg1
- Status last verified
- May 2015
- First submitted
- 4 Jan 2013
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Evaluation of Acute Effects From Khalifa's Therapy at Patients With Fully Ruptured Anterior Cruciate Ligament (ACL).
- ClinicalTrials.gov ID
- NCT01762371
- Acronym / sponsor ID
- KhalSbg1
- Keywords
- ACL, Knee, Ligament, Cruciate, Anterior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K-Pat | Experimental | Other: Khalifa TherapyGetting one time one hour of Khalifa's therapy for ACL injury treatment. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Khalifa TherapyOne hour of Khalifa's therapy which is specially applied pressure to the skin. | Other | K-Pat |
Primary outcome
Laser Doppler-Flow
Time frame: 1 hour
Perfusion
NIRS
Time frame: 1 hour
Near infrared spectroscopy, Oxygen saturation
IR Thermography
Time frame: 1 hour
Infrared thermography, temperature
QST
Time frame: 1 hour
Quantitative sensoric testing, pain
HRV
Time frame: 1 hour
Heart rate variability, sympathicus/parasympathicus activation
EEG
Time frame: 1 hour
Electroencephalogram, brain waves
Knee function
Time frame: 1 hour
IKDC Score KT-1000 test Clinical / physical examination
SportsScience
Time frame: 2 hours
Posturomed Motion capture proprioception muscle power range of motion
Blood
Time frame: 1 hour
Catecholamines endorphins standard blood parameters
1 secondary outcome
Questionnaire
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Kastner, MD principal investigator
AKH Linz
Andreas Sandner, MD principal investigator
Med Uni Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Khalifa Therapy in people with Totally Ruptured Anterior Cruciate Ligament in the Knee, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laser Doppler-Flow (time frame: 1 hour). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.