Knee InjuriesNCT03852199
A Validation Study of Force Sense Measurement
An observational study of Knee Injuries and Proprioceptive Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The term proprioception was first introduced by Sherrington in 1906, who described it as a type of feedback from the limbs to the central nervous system. Based on the early descriptions by Sherrington and others, the contemporary terms of joint position sense (JPS), kinaesthesia (perception of active and passive… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries, Proprioceptive Disorders
- What is being tested?
- Test protocol for proprioceptive force sense in case group
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 15 Dec 2019
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals without chronic knee problems were included in the study.
Who may be able to join
- without chronic knee problems
- without chronic neurologic problems
- without chronic rheumatological problems
- without cognitive problems
Who cannot join
- Osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Validation Study of Force Sense Measurement With a New Instrument
The term proprioception was first introduced by Sherrington in 1906, who described it as a type of feedback from the limbs to the central nervous system. Based on the early descriptions by Sherrington and others, the contemporary terms of joint position sense (JPS), kinaesthesia (perception of active and passive motion), and sense of tension or force sense are considered sub modalities of proprioception.
For the extremity joints, goniometers (universal, bubble, digital) can also be used to measure active JPS. Depending on the device used and the extremity joint measured, reliability and measurement error of active movement goniometry can range widely and this should be carefully considered if goniometry is used to measure active JPS of extremity joints. Kinesthesia, can be measured by calculating the passive motion detection threshold of individuals.
Read more
The force sense (FS), commonly assessed using force reproduction, has also been used as a measure of proprioception. Assessing force reproduction by limb matching involves the use of a reference force, usually determined as a percentage of a Maximal Voluntary Isometric Contraction (MVIC), and attempting to replicate that force.
Proprioception can be decreased in those who suffer from knee injury. Because patients with severe degenerative joint disease often require total knee arthroplasty to relieve pain, improve stability, and restore function. Due to problems such as oedema, immobilization and subjective pain after surgery, it is difficult to evaluate proprioception with joint repositioning method. In such cases, the assessment of FS could be of particular interest in the knee region. FS can also be measured by the accuracy of reproducing a specific target force. For example, the pressure biofeedback device (PBD) used for assessing the cranio-cervical flexion test could be considered a method of assessing force sense in the cervical spine. The ability to hold steadily or the accuracy in achieving and maintaining a desired pressure can be used. However, for the knee region, there is no method to measure the force sense via a device that can be used in clinical practice.
The aim of this study was to establish a method for measuring FS that could be applied quickly and practically in the clinic, and to correlate the outcomes with surface electromyographic (EMG) muscle activation levels from M. Quadriceps femoris to demonstrate the applicability and objectivity of this method.
- Conditions
- Knee Injuries, Proprioceptive Disorders
- Being tested
- Test protocol for proprioceptive force sense in case group
- Keywords
- force sense, knee joint, proprioception, sphygmomanometer, surface EMG
- Medical subject headings
- Knee Injuries, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test protocol for proprioceptive force sense in case groupOther
- The FS in the knee region was measured by the pressure, biofeedback device (Stabilizer ™, Chattanooga Group Inc., Chattanooga, TN).
- Surface EMG device (Noraxon USA, Inc., Scottsdale, AZ) was used to measure activation levels of M. Vastus Medialis Obliquus (VMO), M. Vastus Lateralis (VL) and M. Rectus Femoris (RF) muscles. Due to the characteristics of the Bipolar Ag/AgCl surface electrodes, the distance between the electrodes was set to 1 cm and the electrode width to 2 cm. The electrode placement was determined according to the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) criteria.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Our study was performed with 30 healthy individuals at Hacettepe University, Faculty of Physical Therapy and Rehabilitation. The FS of the knee joint was measured with a Pressure Biofeedback Device (Stabilizer ™, Chattanooga Group Inc., Chattanooga, TN), a device similar to a sphygmomanometer. To correlate the outcomes of biofeedback device, simultaneously, a surface electromyography (EMG) data of M. Quadriceps femoris muscle activation levels from the individuals were recorded. Receives: Other: Test protocol for proprioceptive force sense in case group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of force sensations in mmHg with "Pressure Biofeedback Device" Measurement of Force Sense in mmHg with "Pressure Biofeedback Device"
First, the participants were positioned on the exercise bed. Then, the pressure biofeedback device was placed under the knee joint on the dominant lower extremity side and the cuff was inflated to a pressure of 20 mmHg. Before the measurement, the participants were told to press their knees to the ground and thus to bring the M.Quadriceps femoris into maximum isometric contraction. 50% and 65% of this maximum value obtained for each individual were recorded as reference values for measuring the force sense error of knee region.
Measured: Participants are evaluated only once in 45 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Oct 2018
- Primary completion15 Mar 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Turkmen, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852199
- Sponsor's protocol ID
- GO 18/932
- Status last verified
- Apr 2021
- First submitted
- 19 Feb 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of Force Sense Measurement With a New Instrument
- ClinicalTrials.gov ID
- NCT03852199
- Acronym / sponsor ID
- GO 18/932
- Conditions
- Knee Injuries, Proprioceptive Disorders
- Keywords
- force sense, knee joint, proprioception, sphygmomanometer, surface EMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 25 Feb 2019 (actual)
- 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 term proprioception was first introduced by Sherrington in 1906, who described it as a type of feedback from the limbs to the central nervous system. Based on the early descriptions by Sherrington and others, the contemporary terms of joint position sense (JPS), kinaesthesia (perception of active and passive motion), and sense of tension or force sense are considered sub modalities of proprioception.
For the extremity joints, goniometers (universal, bubble, digital) can also be used to measure active JPS. Depending on the device used and the extremity joint measured, reliability and measurement error of active movement goniometry can range widely and this should be carefully considered if goniometry is used to measure active JPS of extremity joints. Kinesthesia, can be measured by calculating the passive motion detection threshold of individuals.
The force sense (FS), commonly assessed using force reproduction, has also been used as a measure of proprioception. Assessing force reproduction by limb matching involves the use of a reference force, usually determined as a percentage of a Maximal Voluntary Isometric Contraction (MVIC), and attempting to replicate that force.
Proprioception can be decreased in those who suffer from knee injury. Because patients with severe degenerative joint disease often require total knee arthroplasty to relieve pain, improve stability, and restore function. Due to problems such as oedema, immobilization and subjective pain after surgery, it is difficult to evaluate proprioception with joint repositioning method. In such cases, the assessment of FS could be of particular interest in the knee region. FS can also be measured by the accuracy of reproducing a specific target force. For example, the pressure biofeedback device (PBD) used for assessing the cranio-cervical flexion test could be considered a method of assessing force sense in the cervical spine. The ability to hold steadily or the accuracy in achieving and maintaining a desired pressure can be used. However, for the knee region, there is no method to measure the force sense via a device that can be used in clinical practice.
The aim of this study was to establish a method for measuring FS that could be applied quickly and practically in the clinic, and to correlate the outcomes with surface electromyographic (EMG) muscle activation levels from M. Quadriceps femoris to demonstrate the applicability and objectivity of this method.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Other: Test protocol for proprioceptive force sense in case groupOur study was performed with 30 healthy individuals at Hacettepe University, Faculty of Physical Therapy and Rehabilitation. The FS of the knee joint was measured with a Pressure Biofeedback Device (Stabilizer ™, Chattanooga Group Inc., Chattanooga, TN), a device similar to a sphygmomanometer. To correlate the outcomes of biofeedback device, simultaneously, a surface electromyography (EMG) data of M. Quadriceps femoris muscle activation levels from the individuals were recorded. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals without chronic knee problems were included in the study.
Key inclusion criteria (4 listed)
- without chronic knee problems
- without chronic neurologic problems
- without chronic rheumatological problems
- without cognitive problems
Key exclusion criteria (1 listed)
- Osteoporosis
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 |
|---|---|---|
| Test protocol for proprioceptive force sense in case group* The FS in the knee region was measured by the pressure, biofeedback device (Stabilizer ™, Chattanooga Group Inc., Chattanooga, TN). * Surface EMG device (Noraxon USA, Inc., Scottsdale, AZ) was used to measure activation levels of M. Vastus Medialis Obliquus (VMO), M. Vastus Lateralis (VL) and M. Rectus Femoris (RF) muscles. Due to the characteristics of the Bipolar Ag/AgCl surface electrodes, the distance between the electrodes was set to 1 cm and the electrode width to 2 cm. The electrode placement was determined according to the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) criteria. | Other | Case Group |
Primary outcome
Measurement of force sensations in mmHg with "Pressure Biofeedback Device" Measurement of Force Sense in mmHg with "Pressure Biofeedback Device"
Time frame: Participants are evaluated only once in 45 minutes.
First, the participants were positioned on the exercise bed. Then, the pressure biofeedback device was placed under the knee joint on the dominant lower extremity side and the cuff was inflated to a pressure of 20 mmHg. Before the measurement, the participants were told to press their knees to the ground and thus to bring the M.Quadriceps femoris into maximum isometric contraction. 50% and 65% of this maximum value obtained for each individual were recorded as reference values for measuring the force sense error of knee region.
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 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries and Proprioceptive Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 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 8 Apr 2021. 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 Turkey (Türkiye). 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?
Measurement of force sensations in mmHg with "Pressure Biofeedback Device" Measurement of Force Sense in mmHg with "Pressure Biofeedback Device" (time frame: Participants are evaluated only once in 45 minutes.). 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 8 Apr 2021.