The Risk of Falls Index for Patients With Neuromuscular Disorders

The combination of short quantitatively assessing muscular function and balance in combination with short clinical scores, can be a new valid approach to evaluate the patient risk of fall and help to create a quick checkup test to prescribe an appropriate assistive device.

The primary goal of this project is to provide a short battery of clinical assessments used to determine risk of falling for patients with neuromuscular diseases (NMD) based on correlation between clinical assessments between two groups of NMD patients and scales used to assess risk of falling for patients.

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Key information

Conditions

Inclusion Body Myositis Autoimmune Diseases Autoimmune Diseases of the Nervous System Congenital, Hereditary, and Neonatal Diseases and Abnormalities Facioscapulohumeral Muscular Dystrophies Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Immune System Diseases Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Facioscapulohumeral Musculoskeletal Diseases Myasthenia Gravis Myositis Myositis, Inclusion Body Myotonic Disorders Myotonic Dystrophy Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System The Falls Efficacy Scale International The Morse Fall Scale

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marko Mijic

München, Bavaria, 80336, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients between 18- and 65-year-old
Patients with adequate cognitive and communication function to fill out the scales assessing risk of falling
The neuromuscular disease needs to be confirmed by genetic report and/or disease deepening neurophysiological examination.

Exclusion criteria

Patients which are not able to perform motoric functional assessments without assistive gait device.

Treatment and study plan

The risk of falls

Diagnostic Test

Heel-Rise-Test, Chair-Rise Test, Semi-tandem stand, Trunk Rise Test, and Foot-tapping speed. Test battery two includes Timed Up and Go test, 10 Meter Walk Test, Six Minute Walk test, The Falls Efficacy Scale International FES-I, The Morse Fall Scale.

Primary outcomes

FBIndex

Time frame: 2 years

The primary goal of this project is to provide a short battery of clinical assessments used to determine risk of falling for patients with NMDs based on correlation between clinical assessments: Heel-Rise-Test, Chair-Rise Test, Semi-tandem stand, Trunk Rise Test, and Foot-tapping speed, Timed Up and Go test, 10 Meter Walk Test and Six Minute Walk test, between two groups of NMD patients and scales: "The Falls Efficacy Scale International FES-I" and "The Morse Fall Scale" used to assess risk of falling for patients.

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Official study title

The FBIndex to Determine the Risk of Falls and Its Translation to Assistive Gait Device Care for Patients With Neuromuscular Disorders

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jun 6, 2023
Registry last updated: Sep 19, 2024

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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