Position Sense DisordersNCT06057259
Validity and Reliability of Wrist Proprioception Measurement Methods
An observational study of Position Sense Disorders and Wrist, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to compare the validity and reliability of three Different methods used for wrist proprioception measurement in the healthy population. The main question[s] it aims to answer are: Are the methods valid and reliable? Which method is superior? Wrist proprioception measurement of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Position Sense Disorders, Wrist
- What is being tested?
- Joint position sense measurement
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2018to 9 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteer participants
Who may be able to join
- After providing detailed information about the study, individuals who had agreed to participate in the research were included in the study
Who cannot join
- individuals who suffered an injury or underwent a surgical procedure in the last six months that could affect hand functions or senses were excluded from the study.
- Individuals with a history of neuromuscular disease, traumatic nerve injury, congenital anomalies, or skin infections were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Validity and Reliability of Three Different Methods Used for Wrist Proprioception Measurement
The goal of this observational study is to compare the validity and reliability of three Different methods used for wrist proprioception measurement in the healthy population. The main question[s] it aims to answer are:
- Are the methods valid and reliable?
- Which method is superior?
Wrist proprioception measurement of the participants is performed. Researchers compared the inclinometer, goniometer, and joint position sense goniometer to determine the superior method.
Read the detailed description
Proprioception is one of the most important mechanisms involved in ensuring the optimal position of the wrist to prevent injuries. It occurs through stimuli from different structures such as muscle, tendon, joint capsule and skin and provides the perception of the joint's position and movement characteristics (direction, speed, etc.). This perception is essential for effective and safe motor performance. Previous studies have provided evidence that proprioceptive training yields improvements in somatosensory and sensorimotor function. Furthermore, a relationship between the loss of proprioception and motor function has also been demonstrated. Additionally, proprioceptive training reduces the frequency of injuries and provides a faster and more efficient rehabilitation process. Therefore, it is essential to detect proprioceptive defects as a part of patient evaluation which is only achievable by using valid and reliable assessment tools.
Proprioception encompasses both static (i.e., joint position sense (JPS)) and dynamic (i.e., kinesthesia) components of joint perception. Many tools and methods are available to evaluate these components, including universal goniometer, inclinometer, wrist goniometer, mobile applications, robot-assisted assessment, and isokinetic dynamometers. Especially, goniometer, inclinometer, and isokinetic dynamometer are widely used in evaluating proprioception. However, the number of studies on the validity and reliability of these tools is very limited for the wrist. In addition to these tools, the joint position sense goniometer (JPSG) is replicated and used by researchers due to its low cost and accessibility.
Although some studies found goniometer to have high precision in wrist trauma patients, there are still no gold standard tests or tools available for evaluating wrist proprioception. Therefore, it becomes confusing for researchers and clinicians to decide which method should be used in their practice accurately. In line with all these data, the present study aimed to examine the validity and test-retest reliability of two frequently used methods (Goniometer and Inclinometer) and JPSG in wrist proprioception assessment.
The detailed information about the measurements is provided in the "Study Protocol" file.
- Conditions
- Position Sense Disorders, Wrist
- Being tested
- Joint position sense measurement
- Keywords
- joint, hand, sensation, Therapy, Occupational
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint position sense measurementDevice
The participants' wrist joint position sense was evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Inclinometer | Measuring Wrist Joint Position Sense with a Inclinometer Receives: Device: Joint position sense measurement | |
| Goniometer | Measuring Wrist Joint Position Sense with a Goniometer Receives: Device: Joint position sense measurement | |
| Joint position sense goniometer | Measuring Wrist Joint Position Sense with a joint position sense goniometer Receives: Device: Joint position sense measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active joint position sense measurement with the Goniometer
The goniometric (1° scale increments) measurement was performed with the elbow positioned at 90° flexion and resting on the table, the forearm was in mid-pronation, and the fingers were relaxed. The movement axis of the mid-carpal and radiocarpal joints is defined as the pivot point of the goniometer to ensure a compatible measurement of wrist movement. The stable arm of the goniometer was placed parallel to the radius, and the mobile arm followed the third metacarpal bone.
Measured: through study completion, an average of 1 year
Active joint position sense measurement with the Joint Position Sense Goniometer
The JPSG consists of two wooden boards fixed at an angle of 90°. The plate perpendicular to the ground has an opening that the wrist can go through. 0 to 180° angle values with 1° increments were drawn on the plate that parallels the floor. For the evaluation, the participant was asked to sit in front of the table with the trunk upright and the shoulder in the neutral position. The patient's forearm passed through the opening in the JPSG, and the wrist joint was adjusted to match the axis of movement. The forearm was positioned in mid-pronation, the wrist was positioned at 0° flexion/extension, and the forearm was in the neutral position. Participants were asked not to contact the plates during the measurements.
Measured: through study completion, an average of 1 year
Active joint position sense measurement with the Inclinometer
Another tool used to evaluate wrist active joint position sense was the digital dual inclinometer. The limb position used during the inclinometer evaluations was the same as the position for the goniometer. One of the inclinometer sensors was placed on the 3rd metacarpal bone on the dorsal side of the hand. The other sensor was placed on the dorsal side of the forearm, perpendicular to the flexion/extension movement axis.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Active joint position sense measurement with the Cybex Isokinetic Dynamometer
The Cybex isokinetic dynamometer was used as a reference standard to test the validity of the methods. The evaluation of proprioception using the isokinetic dynamometer was performed with the participants in sitting. The shoulder was positioned in the midline, the elbow was flexed about 90°, and the wrist was positioned in supination. During the evaluation, the forearm was fixed with a strap to prevent the forearm from moving and changing the angle of the wrist. The rotation axis of the dynamometer was aligned with the diagonal axis of the distal tubercule of radius and the head of ulna. The wrist was placed in a 0° position. In this starting position, the range of motion was set as 40° flexion and 40°extension. The device was calibrated before the evaluation of each participant.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start2 Jul 2018
- Primary completion12 Apr 2019
- Study completion9 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Position Sense DisordersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barış SEVEN, Gazi University
- Investigators
- Barış SEVEN, Ph.D, Principal investigator, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057259
- Sponsor's protocol ID
- 3
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Validity and Reliability of Three Different Methods Used for Wrist Proprioception Measurement
- ClinicalTrials.gov ID
- NCT06057259
- Acronym / sponsor ID
- 3
- Conditions
- Position Sense Disorders, Wrist
- Keywords
- joint, hand, sensation, Therapy, Occupational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 9 Jun 2019 (actual)
- First posted
- 28 Sep 2023 (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 goal of this observational study is to compare the validity and reliability of three Different methods used for wrist proprioception measurement in the healthy population. The main question[s] it aims to answer are:
- Are the methods valid and reliable?
- Which method is superior?
Wrist proprioception measurement of the participants is performed. Researchers compared the inclinometer, goniometer, and joint position sense goniometer to determine the superior method.
Detailed description
Proprioception is one of the most important mechanisms involved in ensuring the optimal position of the wrist to prevent injuries. It occurs through stimuli from different structures such as muscle, tendon, joint capsule and skin and provides the perception of the joint's position and movement characteristics (direction, speed, etc.). This perception is essential for effective and safe motor performance. Previous studies have provided evidence that proprioceptive training yields improvements in somatosensory and sensorimotor function. Furthermore, a relationship between the loss of proprioception and motor function has also been demonstrated. Additionally, proprioceptive training reduces the frequency of injuries and provides a faster and more efficient rehabilitation process. Therefore, it is essential to detect proprioceptive defects as a part of patient evaluation which is only achievable by using valid and reliable assessment tools.
Proprioception encompasses both static (i.e., joint position sense (JPS)) and dynamic (i.e., kinesthesia) components of joint perception. Many tools and methods are available to evaluate these components, including universal goniometer, inclinometer, wrist goniometer, mobile applications, robot-assisted assessment, and isokinetic dynamometers. Especially, goniometer, inclinometer, and isokinetic dynamometer are widely used in evaluating proprioception. However, the number of studies on the validity and reliability of these tools is very limited for the wrist. In addition to these tools, the joint position sense goniometer (JPSG) is replicated and used by researchers due to its low cost and accessibility.
Although some studies found goniometer to have high precision in wrist trauma patients, there are still no gold standard tests or tools available for evaluating wrist proprioception. Therefore, it becomes confusing for researchers and clinicians to decide which method should be used in their practice accurately. In line with all these data, the present study aimed to examine the validity and test-retest reliability of two frequently used methods (Goniometer and Inclinometer) and JPSG in wrist proprioception assessment.
The detailed information about the measurements is provided in the "Study Protocol" file.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inclinometer | – | Device: Joint position sense measurementMeasuring Wrist Joint Position Sense with a Inclinometer |
| Goniometer | – | Device: Joint position sense measurementMeasuring Wrist Joint Position Sense with a Goniometer |
| Joint position sense goniometer | – | Device: Joint position sense measurementMeasuring Wrist Joint Position Sense with a joint position sense goniometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteer participants
Key inclusion criteria (1 listed)
- After providing detailed information about the study, individuals who had agreed to participate in the research were included in the study
Key exclusion criteria (2 listed)
- individuals who suffered an injury or underwent a surgical procedure in the last six months that could affect hand functions or senses were excluded from the study.
- Individuals with a history of neuromuscular disease, traumatic nerve injury, congenital anomalies, or skin infections were excluded.
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 |
|---|---|---|
| Joint position sense measurementThe participants' wrist joint position sense was evaluated. | Device | Goniometer, Inclinometer, Joint position sense goniometer |
Primary outcome
Active joint position sense measurement with the Goniometer
Time frame: through study completion, an average of 1 year
The goniometric (1° scale increments) measurement was performed with the elbow positioned at 90° flexion and resting on the table, the forearm was in mid-pronation, and the fingers were relaxed. The movement axis of the mid-carpal and radiocarpal joints is defined as the pivot point of the goniometer to ensure a compatible measurement of wrist movement. The stable arm of the goniometer was placed parallel to the radius, and the mobile arm followed the third metacarpal bone.
Active joint position sense measurement with the Joint Position Sense Goniometer
Time frame: through study completion, an average of 1 year
The JPSG consists of two wooden boards fixed at an angle of 90°. The plate perpendicular to the ground has an opening that the wrist can go through. 0 to 180° angle values with 1° increments were drawn on the plate that parallels the floor. For the evaluation, the participant was asked to sit in front of the table with the trunk upright and the shoulder in the neutral position. The patient's forearm passed through the opening in the JPSG, and the wrist joint was adjusted to match the axis of movement. The forearm was positioned in mid-pronation, the wrist was positioned at 0° flexion/extension, and the forearm was in the neutral position. Participants were asked not to contact the plates during the measurements.
Active joint position sense measurement with the Inclinometer
Time frame: through study completion, an average of 1 year
Another tool used to evaluate wrist active joint position sense was the digital dual inclinometer. The limb position used during the inclinometer evaluations was the same as the position for the goniometer. One of the inclinometer sensors was placed on the 3rd metacarpal bone on the dorsal side of the hand. The other sensor was placed on the dorsal side of the forearm, perpendicular to the flexion/extension movement axis.
1 secondary outcome
Active joint position sense measurement with the Cybex Isokinetic Dynamometer
Time frame: through study completion, an average of 1 year
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 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Barış SEVEN, Ph.D principal investigator
İzmir Katip Çelebi University
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 Position Sense Disorders and Wrist, run by Gazi 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 1 inclusion and 2 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 28 Sep 2023. 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?
Active joint position sense measurement with the Goniometer (time frame: through study completion, an average of 1 year). The study lists 3 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 28 Sep 2023.