NCT04464096

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

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

April 10, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

June 18, 2020

Last Update Submit

July 7, 2020

Conditions

Keywords

Rheumatoid arthritisfoot problemsFall riskpredictors

Outcome Measures

Primary Outcomes (6)

  • range of motion

    measured clinically as normal or restricted

    1 week

  • muscle power

    by manual testing with 5 grades where grade 5 means normal power

    1 week

  • sensation

    superficial sensation reported as intact or impaired

    1 week

  • type of foot

    using the wet test . three types of feet either normal, high arched or flat feet.

    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

    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.

    1 week

Interventions

nonOTHER

non

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adult patients with Rheumatoid arthritis .

You may qualify if:

  • Adults with Rheumatoid arthritis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 23139011BACKGROUND
  • Hayashibara 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.

    PMID: 20119662BACKGROUND
  • Oswald 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.

    PMID: 16482644BACKGROUND
  • Armstrong 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.

    PMID: 15817660BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

June 18, 2020

First Posted

July 9, 2020

Study Start

April 10, 2018

Primary Completion

January 30, 2019

Study Completion

February 15, 2019

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

All data is treated confidentially.

Locations