Comparison of Hand Functions and Wrist Proprioception in Patients With and Without Psoriatic Arthritis

September 18, 2020 updated by: Melissa Köprülüoğlu
The purpose of this study is to assess hand functions and wrist joint position sense in patients with and without PsA.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, 54 patients (18 of them RA, 18 of them PsA and, 18 of them asymptomatic healthy group) were included. The patient group was selected from the patients who came to the Izmir Katip Celebi University Ataturk Training and Research Hospital Rheumatology Outpatient Clinic for routine control.

Participants were matched according to age and gender. It was recorded demographic and clinical data.

Grip and pinch strengths were evaluated within the scope of hand function evaluation. Wrist joint position sense was evaluated along with hand functions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Izmir/ Cigli
      • Izmir, Izmir/ Cigli, Turkey
        • Izmir Katip Çelebi University Ataturk Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

54 participants

  • 18 of them PsA
  • 18 of them RA
  • 18 of them asymptomatic healthy group

Description

Inclusion Criteria:

  • to be diagnosed according to CASPAR or ACR/ EULAR 2010 criteria for patient groups
  • taking regular medication for patient groups,
  • have complaints related to hand / wrist joints for patients groups,
  • have no complaints related to upper extremity for asymptomatic healthy group.
  • have any rheumatologic disease and OA diagnosed according to traditional criteria

Exclusion Criteria:

  • finger infection and / or finger amputation,
  • using orthoses,
  • to report a diagnosis of neurological disease,
  • to report a history of trauma or surgery involving the upper extremity,
  • to report a psychiatric and / or cognitive problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Psoriatic Arthritis
Patients diagnosed with PsA according to CASPAR criteria by the rheumatologist were included.
Other: This study does not contain any intervention.
This study does not contain any intervention.
Rheumatoid Arthritis
Patients diagnosed with RA according to ACR / EULAR 2010 criteria by the rheumatologist were included.
Other: This study does not contain any intervention.
This study does not contain any intervention.
Asymptomatic Healthy Group
Participants had any neurological and/or rheumatological diseases, no complaints about the upper extremity. Participants diagnosed with OA according to traditional clinical criteria were excluded from the study.
Other: This study does not contain any intervention.
This study does not contain any intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Grip strenght was examined using a hand dynamometer (Lafayette Proffessional Hand Held Dynamometer, USA).
Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Two-Point Pinch Strength
Time Frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
It was evaluated by pinchmeter (Lafayette,USA).
Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Three-Point Pinch Strength
Time Frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
It was evaluated by pinchmeter (Lafayette,USA).
Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Lateral Pinch Strength
Time Frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
It was evaluated by pinchmeter (Lafayette,USA).
Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
DASH score
Time Frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
The DASH score provides information about the general functionality of the upper extremity and especially activities of hand.
Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Wrist Joint Position Sense
Time Frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.
Wrist joint position sense was evaluated by goniometric re-position error test ( in 30◦ wrist extansion, 3 repeat ).
Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Melissa Köprülüoğlu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: İlknur NAZ GÜRŞAN, PhD, İzmir Katip Celebi University, Faculty of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Izmir Katip Celebi University

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Clinical Study Report

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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