A Validation Study of Force Sense Measurement

NCT ID: NCT03852199

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Injuries Proprioceptive Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Test protocol for proprioceptive force sense in case group

Intervention Type OTHER

* 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* without chronic knee problems
* without chronic neurologic problems
* without chronic rheumatological problems
* without cognitive problems

Exclusion Criteria

* Osteoporosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ceyhun Turkmen

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ceyhun Türkmen

Ankara, Altindag, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GO 18/932

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.