Rheumatoid ArthritisNCT05819242
The Reliability And Validity Of A Smartphone App
An observational study of Rheumatoid Arthritis and Carpal Tunnel Syndrome, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to validate a smartphone app called Angulus. The main question it aims to answer is: Is an Angulus App valid and reliable system for masuring hand and wrist range of motion? Participants will be evaluated by goniometers which is a gold standart for range of motion assessment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Carpal Tunnel Syndrome
- What is being tested?
- Angulus
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2023to 5 Oct 2023
- How long will I take part?
- 1 Year
- 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: Healthy
Who may be able to join
- a history of previous traumatic hand or wrist injury in the upper extremity,
- pain in the hand and wrist during evaluation
- orthopedic, neurologic, or rheumatologic disease
Who cannot join
- not to understand the command that the therapist give
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability And Validity Of A Smartphone App For Measuring Wrist And Metacarpophalangeal Joint Motion
The goal of this observational study is to validate a smartphone app called Angulus. The main question it aims to answer is:
- Is an Angulus App valid and reliable system for masuring hand and wrist range of motion?
Participants will be evaluated by goniometers which is a gold standart for range of motion assessment.
- Conditions
- Rheumatoid Arthritis, Carpal Tunnel Syndrome
- Being tested
- Angulus
- Keywords
- reliability, validity, range of motion
- Medical subject headings
- Arthritis, Rheumatoid, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngulusDiagnostic test
Smartphone app
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Not described Receives: Diagnostic Test: Angulus | |
| Rheumatoid Arthritis | Not described Receives: Diagnostic Test: Angulus | |
| Carpal Tunnel Syndrome | Not described Receives: Diagnostic Test: Angulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motions
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start7 Apr 2023
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819242
- Sponsor's protocol ID
- AEUFTR
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability And Validity Of A Smartphone App For Measuring Wrist And Metacarpophalangeal Joint Motion
- ClinicalTrials.gov ID
- NCT05819242
- Acronym / sponsor ID
- AEUFTR
- Conditions
- Rheumatoid Arthritis, Carpal Tunnel Syndrome
- Keywords
- reliability, validity, range of motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 19 Apr 2023 (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.
The goal of this observational study is to validate a smartphone app called Angulus. The main question it aims to answer is:
- Is an Angulus App valid and reliable system for masuring hand and wrist range of motion?
Participants will be evaluated by goniometers which is a gold standart for range of motion assessment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | Diagnostic Test: Angulus |
| Rheumatoid Arthritis | – | Diagnostic Test: Angulus |
| Carpal Tunnel Syndrome | – | Diagnostic Test: Angulus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy
Key inclusion criteria (3 listed)
- a history of previous traumatic hand or wrist injury in the upper extremity,
- pain in the hand and wrist during evaluation
- orthopedic, neurologic, or rheumatologic disease
Key exclusion criteria (1 listed)
- not to understand the command that the therapist give
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 |
|---|---|---|
| AngulusSmartphone app | Diagnostic test | Carpal Tunnel Syndrome, Healthy Adults, Rheumatoid Arthritis |
Primary outcome
Range of Motions
Time frame: 15 weeks
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 6 Oct 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rheumatoid Arthritis and Carpal Tunnel Syndrome, run by Kirsehir Ahi Evran Universitesi 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 3 inclusion and 1 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 6 Oct 2023. 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?
Range of Motions (time frame: 15 weeks). 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 6 Oct 2023.