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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04540809
Other study ID # 2019 / 7-21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2019
Est. completion date July 15, 2019

Study information

Verified date September 2020
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date July 15, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Turkey Inonu University Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Handgrip strength Handgrip was measured with the Baseline Digital Hand Dynamometer 135 KG®. The results were recorded as Kg. 3 months
Primary Pinch strength Pinch strength was measured with the Baseline Hydraulic Compaction Meter 45 KG®. The results were recorded as Kg. 3 months
Primary Wrist proprioception 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
Primary Finger skills Finger skills were recorded as points at the end of 30 seconds with the mobile application. Higher scores indicate better functional status. 3 months
Primary Both hand skill and coordination 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 Disease activity 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
Secondary Michigan Hand Outcomes Questionnaire 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
Secondary Health Assessment Questionnaire 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
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