NCT04717505

Brief Summary

Chronic pain is pain that exceeds the duration of the injury or trigger stimulus and lasts for at least three months. Recent studies show that chronic pain has devastating effects on cognitive functions by causing emotional stress, anxiety, and depression.The studies show that chronic pain affects certain cognitive areas. These areas are; processing speed, short-term memory, longterm memory, inhibitory control and working memory. In addition, task-oriented studies show that chronic pain affects not single tasks, but rather dual tasks that require the use of complex cognitive function (executive function). 40-60% of rheumatologic patients do not have sufficient relief in their pain. For this reason, dual task performance may be affected in individuals diagnosed with rheumatological disease, secondary to the impairment of cognition. In the literature, there are only limited studies showing dual-task performance effects in individuals diagnosed with fibromyalgia and osteoarthritis. However, chronic pain is the main health problem that prevents mobility restriction and participation in all rheumatic diseases. In addition, there is no study investigating the dual task performance effect in rheumatic diseases in a comprehensive way. Therefore, the aim of the study is to investigate the effect of rheumatic diseases on dual-task performance by comparing it with the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

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

November 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

January 14, 2021

Last Update Submit

January 18, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Gait Speed

    The time it takes to walk a specified distance

    10 minutes

  • Cadence

    Number of steps per minute

    10 minutes

  • Step lengths

    Step length is the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot.

    10 minutes

Study Arms (2)

Healthy Control Group

Demographic information ( age, gender, occupation, weight, height) of all participants in the study will be recorded first. The cognitive functions of all participants within the scope of the study will be evaluated in the Standardized Mini Mental Test; The 10 Meter Walk Test for dual task assessments will be applied in 3 different ways, with a portable gait device with wearable sensors: 1-single task conditions, 2-dual task conditions (motor + cognitive), 3-dual task conditions (motor + motor).

Other: Gait AssessmentsOther: Standardized Mini Mental Test

Rheumatological Condition Group

Demographic information (diagnosis, age, gender, occupation, weight, height) of all participants in the study will be recorded first. The cognitive functions of all participants within the scope of the study will be evaluated in the Standardized Mini Mental Test; The 10 Meter Walk Test for dual task assessments will be applied in 3 different ways, with a portable gait device with wearable sensors: 1-single task conditions, 2-dual task conditions (motor + cognitive), 3-dual task conditions (motor + motor). In addition, in order to evaluate their health status, only the case group will be applied Arthritis Impact Measurement Scales 2 (questionnaire) and Visual Analogue Scale for pain assessment.

Other: Gait AssessmentsOther: Arthritis Impact Measurement Scales 2Other: Visual Analogue ScaleOther: Standardized Mini Mental Test

Interventions

10 Meter Walking Test: It is applied by walking at a normal walking speed (like walking in a shopping mall) without any assistance at a marked distance of 10 meters. 1- Evaluation of walking under single task conditions is done with the 10 Meter Walk Test and without any cognitive or motor second task. Evaluation of walking under dual task conditions is applied in two different ways: 2-adding a cognitive task to the walking motor task (motor + cognitive dual task) 3-adding one more motor task to the walking motor task (motor + motor dual task). While performing dual tasks, the time-distance (walking speed, cadence, stride length) characteristics of the gait are recorded using with wearable gait device.

Also known as: 10 meter Walking Test
Healthy Control GroupRheumatological Condition Group

It is a multidimensional, disease-specific, self-administered questionnaire designed to measure health status outcomes in patients with arthritis.

Rheumatological Condition Group

The Visual Analogue Scale is a reliable and easily applicable scale used to measure the pain intensity of patients, accepted in the world literature.

Rheumatological Condition Group

Although the test has limited specificity in terms of differentiating clinical syndromes, it is a short, useful and standardized method that can be used to determine the cognitive level globally.

Healthy Control GroupRheumatological Condition Group

Eligibility Criteria

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

For case group: Patients who come to Afyonkarahisar Health Sciences University Hospital Rheumatology Outpatient Clinic for treatment will constitute the case group of the study. For control group: Healthy individuals working in Afyonkarahisar Health Sciences University will constitute the control group of the study.

You may qualify if:

  • For the case group
  • Having been diagnosed with any rheumatic disease (rheumatoid arthritis, ankylosing spondylitis… etc.) by a rheumatologist.
  • Not having any acute (fracture, surgery, etc.) or chronic disease (cognitive, neurological, etc.) other than rheumatic disease
  • Being in the age range of 18-65.
  • Presence of chronic pain for at least 3 months
  • Pain over 3.4 cm according to the Visual Analogue Scale (having moderate pain).
  • Standardized Mini Mental Test score\> 24
  • At least primary education or literacy
  • For control group:
  • Absence of any known acute (fracture, surgery, etc.) or chronic disease (cognitive, neurological, etc.)
  • Being in the age range of 18-65
  • Standardized Mini Mental Test score\> 24
  • Having at least primary education or literacy

You may not qualify if:

  • Both control and case groups
  • The presence of any problems (physical, cognitive or psychological) that will prevent the evaluations to be applied within the scope of the research
  • Being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, 03030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • EMEL TAŞVURAN HORATA

    Afyonkarahisar Health Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Assistant Professor

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 22, 2021

Study Start

November 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations