The Effect of Psoriatic Arthritis on the Functions of the Hand

September 4, 2020 updated by: Burcu Talu, Inonu University

Effect of Psoriatic Arthritis on the Strength, Proprioception, Skill, Coordination, and Functional Condition of the Hand

This study was planned to evaluate the effect of psoriatic arthritis on the strength, proprioception, skill, coordination, and functional condition of the hand and to determine the correlate disease activity with these parameters.

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

Psoriatic arthritis (PsA) is a chronic, progressive, inflammatory arthritis that occurs as a condition associated with patients with psoriasis and may result in permanent joint damage and an increased risk of mortality. Synovial membrane inflammation characterized by increased vascularization and immune cell infiltration is an important feature of psoriatic arthritis. This inflamed synovial microenvironment leads to the formation of synovial pannus, entheseal inflammation, and joint damage. Although PsA is generally thought of as a benign arthropathy, structural damage has been shown with the progression of the disease, along with joint inflammation.As a result of the researches, it has been stated that tissue biomechanical stress and microtraumas that lead to the activation of abnormal natural immune responses in psoriatic arthritis can trigger joint inflammation. In parallel, inflammation is expected to be more common in peripheral joints, which are known to be more exposed to microtrauma. Studies have reported that hand joint involvement is frequently seen in patients with PsA and is an important cause of loss of function and that erosions in hand joints are associated with statistically significant loss of hand strength. Theoretically, either the mechanical effect of the fluid in the acute joint effusion or the components of the inflammatory fluid and the changing capsular compliance after chronic effusion and has been reported that problems may occur in proprioception due to causes such as pain, trauma, and fatigue. However, pain, decreased joint ROM and grip strength, muscle weakness, and hand deformities can affect hand fine hand skills and function. The hypothesis of this study is that supporting the clinical condition of the participants with parameters related to general hand function will be effective in predicting disease progression and disability. Accordingly, the aim of the researchers is to evaluate the effect of PsA on the grip and pinch strength of the hand, proprioception, skill, coordination and functional status, and to determine the relationship of disease activity with these parameters.

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.
56

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
      • Malatya, Turkey
        • Inonu University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals and healthy controls diagnosed with PsA according to the classification criteria for PsA (Classification Criteria for Psoriatic Arthritis, CASPAR).

Description

Inclusion Criteria:

  • Individuals between the ages of 18-65

Exclusion Criteria:

  • Neurological diseases that caused sequelae at hand, upper extremity surgeries, neuropathies, traumas, and history of nerve damage
  • Psychiatric disorders,
  • Reluctance to continue evaluation

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

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 group (PsAG)
The evaluation was made using dynamometer, goniometer, mobile application, and Purdue pegboard test.
Other: Assessment of strength, proprioception, skill and coordination of the hand
Disease Activity Score 28 was used to determine the disease activity of patients with PsA. Grip strength was measured with the help of Baseline Digital Hand Dynamometer®. Pinch strength was measured with Baseline Hydraulic Pinch Gauge®. Wrist proprioception was assessed by measuring the joint position sensation using a goniometer by actively repeating the target angle predetermined by the researcher (30 ° for flexion and extension, 15 ° for ulnar deviation, 10 ° for radial deviation. Finger skills were assessed using a mobile application called Ball Tap©. The application included the fastest contact of the participants to the balls coming from different parts of the screen for 30 seconds. Two hand coordination and skills were evaluated using the Purdue Pegboard test. The Michigan Hand Outcomes Questionnaire was used for functional evaluation of the hand, and the Health Assessment Questionnaire was used to assess the general functional condition and health-related quality of life.

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
Handgrip strength
Time Frame: 3 months
Handgrip was measured with the Baseline Digital Hand Dynamometer 135 KG®. The results were recorded as Kg.
3 months
Pinch strength
Time Frame: 3 months
Pinch strength was measured with the Baseline Hydraulic Compaction Meter 45 KG®. The results were recorded as Kg.
3 months
Wrist proprioception
Time Frame: 3 months
Wrist proprioception was assessed by measuring joint position sense with a goniometer. Error average of 3 repetitions in each movement axis was recorded. Low scores indicate a better functional status.
3 months
Finger skills
Time Frame: 3 months
Finger skills were recorded as points at the end of 30 seconds with the mobile application. Higher scores indicate better functional status.
3 months
Both hand skill and coordination
Time Frame: 3 months
Both hand skill and coordination were evaluated using the Purdue Pegboard test. It consists of 4 parts. These; right and left hand, both hands, and assembly. Higher scores indicate better function.
3 months

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
Disease activity
Time Frame: 3 months
DAS28 is a measurement method that determines the disease activity by using the number of painful and swollen joints, ESR (erythrocyte sedimentation rate) or C-reactive protein values in the first hour, and a 100 mm visual analog scale for general evaluation. ESR was used in this study. Higher scores indicate higher disease activity.
3 months
Michigan Hand Outcomes Questionnaire
Time Frame: 3 months
The MHQ is a self-report measure that assesses the function of hand (s) and / or wrist (s). The MHQ contains six distinct scales including overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. Each question is scored on a scale of 1-5. High score in total scores indicates high satisfaction.
3 months
Health Assessment Questionnaire
Time Frame: 3 months
It is a questionnaire consisting of 8 subtitles evaluating daily life activities. Each question ranges from zero (no functional impairment) to three (task disabling). Points between 0-60 are received.Lower scores indicate better conditions.
3 months

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.
Inonu University

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.
April 15, 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.
July 1, 2019

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.
July 15, 2019

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).
August 28, 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 4, 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 7, 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 7, 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 4, 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.
  • 2019 / 7-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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