Status:
UNKNOWN
Accelerometry in Follow up of Arthritis - a Pilot Study
Lead Sponsor:
Helse Forde
Conditions:
Arthritis, Rheumatoid
Spondyloarthritis
Eligibility:
All Genders
18+ years
Brief Summary
This is a proof-of-concept study. The main goal is to evaluate if the accelerometry signal recorded from patients with arthritis in different disease activity stages, allows for assessment of the acti...
Detailed Description
Study type: Observational, proof-of-concept Objectives: Primary objective: To evaluate if an accelerometer signal in patients with active arthritis differs from the signal taken in inactive arthriti...
Eligibility Criteria
Inclusion
- Patients:
- Clinical diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondyloarthritis (SPA).
- Planned or newly started (within 4 weeks before baseline visit) disease-modifying treatment.
- Disis activity defined as:
- RA - DAS28 (ESR or CRP) minimum 3.2,
- PsA - DAPSA minimum 15,
- SPA - BASDAI minimum 4.0.
- A minimum number of tender or swollen joints:
- RA - 4/4,
- PsA - 2/2,
- SPA - not applicable.
- Subject without comorbidities defined in the exclusion criteria.
- Willing to participate and consent competent.
- Over 18 years old.
- Controls:
- Without any inflammatory rheumatic disease
- Without any comorbidity as defined in the exclusion criteria.
- Willing to participate and consent competent.
- Over 18 years old.
Exclusion
- Both patients and controls:
- Chronic neurologic disorders such as multiple sclerosis, parkinsonism, active epilepsy, symptomatic peripheral neuropathy, sequels after radiculopathy or other central nervous system deficit.
- Paresis after cerebral stroke (mild deficits or TIA can be allowed).
- Serious heart failure (NYHA 3 or above).
- Pregnancy.
- Active psychotic disorder.
- Activ alcohol or drug addiction.
- Fast use of medicine that can significantly influence CNS function (low dose sleeping medicine 12 hours before a visit can be allowed).
- Spinal compression fractures less than six months before baseline.
- Other limb fractures, within 4 months before baseline if it can influence patient's mobility
- Other medical conditions that can influence patient's mobility
Key Trial Info
Start Date :
May 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05301621
Start Date
May 12 2022
End Date
December 31 2023
Last Update
August 16 2022
Active Locations (1)
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1
Pawel Mielnik
Førde, Vestlandet, Norway, 6812