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NCT Number: NCT04464096

Can 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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with Rheumatoid arthritis.

Exclusion criteria

  • 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.

Treatment and study plan

non

Other

non

Primary outcomes

  1. range of motion

    Time frame: 1 week

    measured clinically as normal or restricted

  2. muscle power

    Time frame: 1 week

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

  3. sensation

    Time frame: 1 week

    superficial sensation reported as intact or impaired

  4. type of foot

    Time frame: 1 week

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

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Can Ankle and Foot Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2020
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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