Rheumatic DiseasesNCT04717505
Dual Task Performance in Rheumatic Diseases
An observational study of Rheumatic Diseases, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Gait Assessments, Arthritis Impact Measurement Scales 2 and Visual Analogue Scale
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar, 03030
About this study
Official title: Evaluation of Dual Task Performance in Rheumatic Diseases: A Case-Control Study
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.
Read the detailed description
Pain is an unpleasant sensory or emotional experience associated with actual or potential tissue damage and is classified as acute or chronic. Acute pain is felt for a short time after an injury or harmful stimulus and is considered part of a defense strategy; It points to an active danger to the organism. Chronic 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. Studies show that chronic pain affects certain cognitive areas. These areas are; processing speed, short-term memory, long-term memory, inhibitory control and working memory. In addition, task-oriented studies show that chronic pain affects not simple tasks, but rather dual tasks that require the use of complex cognitive function (executive function).
Task; it is a behavior, skill or ability that needs to be done. The simple (single) task contains only one alert or task. For example, walking. Dual task requires the simultaneous performance of two different tasks that can be measured independently and have different goals. For example, calculating while walking at the same time. In rehabilitation approaches, single or dual task trainings are applied. Among physiotherapy and rehabilitation approaches, single task training consists only of exercises involving motor performance; Dual task trainings can consist of different exercise combinations that require two different tasks to be performed at the same time as motor + motor, cognitive + cognitive or motor + cognitive performances. The clinical benefit of dual task training is that most of the daily living activities are done in dual task conditions.
Chronic pain is a common health problem associated with most rheumatic diseases. It is pain that lasts for at least 3 months and cannot be completely relieved with standard pain medication. 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 thestudy is to investigate the effect of rheumatic diseases on dual-task performance by comparing it with the control group.
- Conditions
- Rheumatic Diseases
- Being tested
- Gait Assessments, Arthritis Impact Measurement Scales 2, Visual Analogue Scale, Standardized Mini Mental Test
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait AssessmentsOther
Also called 10 meter Walking Test
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.
Arthritis Impact Measurement Scales 2Other
It is a multidimensional, disease-specific, self-administered questionnaire designed to measure health status outcomes in patients with arthritis.
Visual Analogue ScaleOther
The Visual Analogue Scale is a reliable and easily applicable scale used to measure the pain intensity of patients, accepted in the world literature.
Standardized Mini Mental TestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Gait Assessments; Other: 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. Receives: Other: Gait Assessments; Other: Arthritis Impact Measurement Scales 2; Other: Visual Analogue Scale; Other: Standardized Mini Mental Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
The time it takes to walk a specified distance
Measured: 10 minutes
Cadence
Number of steps per minute
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Nov 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- EMEL TAŞVURAN HORATA, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717505
- Sponsor's protocol ID
- 2020/513
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dual Task Performance in Rheumatic Diseases: A Case-Control Study
- ClinicalTrials.gov ID
- NCT04717505
- Acronym / sponsor ID
- 2020/513
- Conditions
- Rheumatic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain is an unpleasant sensory or emotional experience associated with actual or potential tissue damage and is classified as acute or chronic. Acute pain is felt for a short time after an injury or harmful stimulus and is considered part of a defense strategy; It points to an active danger to the organism. Chronic 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. Studies show that chronic pain affects certain cognitive areas. These areas are; processing speed, short-term memory, long-term memory, inhibitory control and working memory. In addition, task-oriented studies show that chronic pain affects not simple tasks, but rather dual tasks that require the use of complex cognitive function (executive function).
Task; it is a behavior, skill or ability that needs to be done. The simple (single) task contains only one alert or task. For example, walking. Dual task requires the simultaneous performance of two different tasks that can be measured independently and have different goals. For example, calculating while walking at the same time. In rehabilitation approaches, single or dual task trainings are applied. Among physiotherapy and rehabilitation approaches, single task training consists only of exercises involving motor performance; Dual task trainings can consist of different exercise combinations that require two different tasks to be performed at the same time as motor + motor, cognitive + cognitive or motor + cognitive performances. The clinical benefit of dual task training is that most of the daily living activities are done in dual task conditions.
Chronic pain is a common health problem associated with most rheumatic diseases. It is pain that lasts for at least 3 months and cannot be completely relieved with standard pain medication. 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 thestudy is to investigate the effect of rheumatic diseases on dual-task performance by comparing it with the control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | – | Other: Gait Assessments, Other: Standardized Mini Mental TestDemographic 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). |
| Rheumatological Condition Group | – | Other: Gait Assessments, Other: Arthritis Impact Measurement Scales 2, Other: Visual Analogue Scale, Other: Standardized Mini Mental TestDemographic 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- For the case group
- For control group:
Key exclusion criteria (3 listed)
- Both control and case groups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait AssessmentsAlso: 10 meter Walking Test10 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. | Other | Healthy Control Group, Rheumatological Condition Group |
| Arthritis Impact Measurement Scales 2It is a multidimensional, disease-specific, self-administered questionnaire designed to measure health status outcomes in patients with arthritis. | Other | Rheumatological Condition Group |
| Visual Analogue ScaleThe Visual Analogue Scale is a reliable and easily applicable scale used to measure the pain intensity of patients, accepted in the world literature. | Other | Rheumatological Condition Group |
| Standardized Mini Mental TestAlthough 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. | Other | Healthy Control Group, Rheumatological Condition Group |
Primary outcome
Gait Speed
Time frame: 10 minutes
The time it takes to walk a specified distance
Cadence
Time frame: 10 minutes
Number of steps per minute
Step lengths
Time frame: 10 minutes
Step length is the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMEL TAŞVURAN HORATA principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022; AzTrials last refreshed its copy on 28 Oct 2026.