NCT04553302

Brief Summary

The purpose of this study is to assess hand functions and wrist joint position sense in patients with and without PsA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

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

October 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

September 5, 2020

Last Update Submit

September 18, 2020

Conditions

Keywords

Psoriatic Arthritis, Hand Function, Wrist Proprioception.

Outcome Measures

Primary Outcomes (1)

  • Grip Strength

    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 Outcomes (5)

  • Two-Point Pinch Strength

    Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.

  • Three-Point Pinch Strength

    Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.

  • Lateral Pinch Strength

    Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.

  • DASH score

    Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.

  • Wrist Joint Position Sense

    Data collection will continue until September 2019. Data analysis and report preparation will be completed by August 2020.

Study Arms (3)

Psoriatic Arthritis

Patients diagnosed with PsA according to CASPAR criteria by the rheumatologist were included.

Other: 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.

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.

Interventions

This study does not contain any intervention.

Asymptomatic Healthy GroupPsoriatic ArthritisRheumatoid Arthritis

Eligibility Criteria

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

54 participants * 18 of them PsA * 18 of them RA * 18 of them asymptomatic healthy group

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University Ataturk Research and Training Hospital

Izmir, Izmir/ Cigli, Turkey (Türkiye)

Location

Related Publications (5)

  • INNES, E. V. Handgrip strength testing: a review of the literature. Australian Occupational Therapy Journal, 1999, 46.3: 120-140.

    BACKGROUND
  • Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.

    PMID: 6715829BACKGROUND
  • Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

    PMID: 8773720BACKGROUND
  • Navsarikar A, Gladman DD, Husted JA, Cook RJ. Validity assessment of the disabilities of arm, shoulder, and hand questionnaire (DASH) for patients with psoriatic arthritis. J Rheumatol. 1999 Oct;26(10):2191-4.

    PMID: 10529138BACKGROUND
  • Feced Olmos CM, Alvarez-Calderon O, Hervas Marin D, Ivorra Cortes J, Pujol Marco C, Roman Ivorra JA. Relationship between structural damage with loss of strength and functional disability in psoriatic arthritis patients. Clin Biomech (Bristol). 2019 Aug;68:169-174. doi: 10.1016/j.clinbiomech.2019.06.009. Epub 2019 Jun 11.

    PMID: 31220740BACKGROUND

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • İlknur NAZ GÜRŞAN, PhD

    İzmir Katip Celebi University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 5, 2020

First Posted

September 17, 2020

Study Start

October 1, 2019

Primary Completion

June 1, 2020

Study Completion

August 30, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations