Rheumatoid ArthritisNCT04464096
Can Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?
An observational study of Rheumatoid Arthritis, run by Assiut University at 1 site in Egypt.
Trial summary
Rheumatoid patients have higher fall risk than normal population. Several fall risk factors were studied. No previous study investigated the role of musculoskeletal ultrasound as a predictor of fall risk in rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- non
- How many people
- 101 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2018to 15 Feb 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients with Rheumatoid arthritis .
Who may be able to join
- Adults with Rheumatoid arthritis.
Who cannot join
- patients aged < 18 years
- Patients with lower limb disability preventing the participant from performing the mobility tests,
- Patients who were using antidepressants and sedatives.
- Patients with severe comorbidities, severe vision impairment, or hearing loss or neurological diseases that interferes with the mobility as stroke or neuropathy, were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Ankle and Foot Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?
Rheumatoid patients have higher fall risk than normal population. Several fall risk factors were studied. No previous study investigated the role of musculoskeletal ultrasound as a predictor of fall risk in rheumatoid arthritis.
Read the detailed description
Adults with rheumatoid arthritis are exposed to higher risk of fracture. Risk factors included joint tenderness, fatigue, muscle weakness, impaired balance and disease activity.
Musculoskeletal ultrasound is a bed side radiographic tool that gained much attention in the last decade.It can detect stuctural chnges in the musculoskeletal system even before beeing detected by the x ray.
Nowadays, musculoskeletal ultrasound is a very useful tool in examining rheumatoid patients.
No previous study was done to investigate the role of musculoskeletal ultrasound as a predicting factor of fall risk in rheumatoid patients.
Predicting the fall risk in such disease could help setting preventing measures to prevent falls with its sequels.
- Conditions
- Rheumatoid Arthritis
- Being tested
- non
- Keywords
- Rheumatoid arthritis, foot problems, Fall risk, predictors
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonOther
non
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
measured clinically as normal or restricted
Measured: 1 week
muscle power
by manual testing with 5 grades where grade 5 means normal power
Measured: 1 week
sensation
superficial sensation reported as intact or impaired
Measured: 1 week
type of foot
using the wet test . three types of feet either normal, high arched or flat feet.
Measured: 1 week
Tenitti balance assessment tool
The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls
Measured: 1 week
Berge Balance assessment
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function A score of < 45 indicates individuals may be at greater risk of falling.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start10 Apr 2018
- Primary completion30 Jan 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, safaa Mahran, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464096
- Sponsor's protocol ID
- 17101098
- Status last verified
- Jul 2020
- First submitted
- 18 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data is treated confidentially.
Publications
Stanmore EK, Oldham J, Skelton DA, O'Neill T, Pilling M, Campbell AJ, Todd C. Fall incidence and outcomes of falls in a prospective study of adults with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):737-44. doi: 10.1002/acr.21892.
PubMed 23139011Hayashibara M, Hagino H, Katagiri H, Okano T, Okada J, Teshima R. Incidence and risk factors of falling in ambulatory patients with rheumatoid arthritis: a prospective 1-year study. Osteoporos Int. 2010 Nov;21(11):1825-33. doi: 10.1007/s00198-009-1150-4. Epub 2010 Jan 30.
PubMed 20119662Oswald AE, Pye SR, O'Neill TW, Bunn D, Gaffney K, Marshall T, Silman AJ, Symmons DP. Prevalence and associated factors for falls in women with established inflammatory polyarthritis. J Rheumatol. 2006 Apr;33(4):690-4. Epub 2006 Feb 15.
PubMed 16482644Armstrong C, Swarbrick CM, Pye SR, O'Neill TW. Occurrence and risk factors for falls in rheumatoid arthritis. Ann Rheum Dis. 2005 Nov;64(11):1602-4. doi: 10.1136/ard.2004.031195. Epub 2005 Apr 7.
PubMed 15817660
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Ankle and Foot Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?
- ClinicalTrials.gov ID
- NCT04464096
- Acronym / sponsor ID
- 17101098
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, foot problems, Fall risk, predictors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 9 Jul 2020 (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.
Rheumatoid patients have higher fall risk than normal population. Several fall risk factors were studied. No previous study investigated the role of musculoskeletal ultrasound as a predictor of fall risk in rheumatoid arthritis.
Detailed description
Adults with rheumatoid arthritis are exposed to higher risk of fracture. Risk factors included joint tenderness, fatigue, muscle weakness, impaired balance and disease activity.
Musculoskeletal ultrasound is a bed side radiographic tool that gained much attention in the last decade.It can detect stuctural chnges in the musculoskeletal system even before beeing detected by the x ray.
Nowadays, musculoskeletal ultrasound is a very useful tool in examining rheumatoid patients.
No previous study was done to investigate the role of musculoskeletal ultrasound as a predicting factor of fall risk in rheumatoid patients.
Predicting the fall risk in such disease could help setting preventing measures to prevent falls with its sequels.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients with Rheumatoid arthritis .
Key inclusion criteria (1 listed)
- Adults with Rheumatoid arthritis.
Key exclusion criteria (4 listed)
- patients aged < 18 years
- Patients with lower limb disability preventing the participant from performing the mobility tests,
- Patients who were using antidepressants and sedatives.
- Patients with severe comorbidities, severe vision impairment, or hearing loss or neurological diseases that interferes with the mobility as stroke or neuropathy, were also excluded.
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 |
|---|---|---|
| nonnon | Other | – |
Primary outcome
range of motion
Time frame: 1 week
measured clinically as normal or restricted
muscle power
Time frame: 1 week
by manual testing with 5 grades where grade 5 means normal power
sensation
Time frame: 1 week
superficial sensation reported as intact or impaired
type of foot
Time frame: 1 week
using the wet test . three types of feet either normal, high arched or flat feet.
Tenitti balance assessment tool
Time frame: 1 week
The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls
Berge Balance assessment
Time frame: 1 week
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function A score of < 45 indicates individuals may be at greater risk of falling.
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 9 Jul 2020.
- Background: PubMed 23139011Stanmore EK, Oldham J, Skelton DA, O'Neill T, Pilling M, Campbell AJ, Todd C. Fall incidence and outcomes of falls in a prospective study of adults with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):737-44. doi: 10.1002/acr.21892.
- Background: PubMed 20119662Hayashibara M, Hagino H, Katagiri H, Okano T, Okada J, Teshima R. Incidence and risk factors of falling in ambulatory patients with rheumatoid arthritis: a prospective 1-year study. Osteoporos Int. 2010 Nov;21(11):1825-33. doi: 10.1007/s00198-009-1150-4. Epub 2010 Jan 30.
- Background: PubMed 16482644Oswald AE, Pye SR, O'Neill TW, Bunn D, Gaffney K, Marshall T, Silman AJ, Symmons DP. Prevalence and associated factors for falls in women with established inflammatory polyarthritis. J Rheumatol. 2006 Apr;33(4):690-4. Epub 2006 Feb 15.
- Background: PubMed 15817660Armstrong C, Swarbrick CM, Pye SR, O'Neill TW. Occurrence and risk factors for falls in rheumatoid arthritis. Ann Rheum Dis. 2005 Nov;64(11):1602-4. doi: 10.1136/ard.2004.031195. Epub 2005 Apr 7.
- Individual participant dataSharing planned: No. All data is treated confidentially.
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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, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 4 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 9 Jul 2020. 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 Egypt. 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 motion (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04464096, which also lists 4 linked publications.
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 9 Jul 2020.