NCT06057259

Brief 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 the participants is performed. Researchers compared the inclinometer, goniometer, and joint position sense goniometer to determine the superior method.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 6, 2023

Last Update Submit

September 20, 2023

Conditions

Keywords

jointhandsensationTherapyOccupational

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Active joint position sense measurement with the Cybex Isokinetic Dynamometer

    through study completion, an average of 1 year

Study Arms (3)

Inclinometer

Measuring Wrist Joint Position Sense with a Inclinometer

Device: Joint position sense measurement

Goniometer

Measuring Wrist Joint Position Sense with a Goniometer

Device: Joint position sense measurement

Joint position sense goniometer

Measuring Wrist Joint Position Sense with a joint position sense goniometer

Device: Joint position sense measurement

Interventions

The participants' wrist joint position sense was evaluated.

GoniometerInclinometerJoint position sense goniometer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteer participants

You may qualify if:

  • After providing detailed information about the study, individuals who had agreed to participate in the research were included in the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barış SEVEN

Izmir, Çiğli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Somatosensory Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Barış SEVEN, Ph.D

    İzmir Katip Çelebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. research assistant

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 28, 2023

Study Start

July 2, 2018

Primary Completion

April 12, 2019

Study Completion

June 9, 2019

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations