The Risk of Falls Index for Patients With Neuromuscular Disorders

NCT05890833 | Completed

• 1 other identifier: FBIndex_80336
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inclusion Body Myositis; Myotonic Dystrophy; Facioscapulohumeral Muscular Dystrophies; Myasthenia Gravis; The Falls Efficacy Scale International; The Morse Fall Scale

Outcome Measures

Primary Outcomes (1)

• FBIndex

  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.

  2 years

Study Arms (1)

Neuromuscular disorders

Diagnostic Test: The risk of falls

Interventions

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.

Neuromuscular disorders

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Following neuromuscular diseases are included in the study: inclusion body myositis, myotonic dystrophies, limb girdle and facioscapulohumeral muscular dystrophies, and myasthenia gravis.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• LMU Klinikum: lead

Study Sites (1)

Marko Mijic

München, Bavaria, 80336, Germany

Location

MeSH Terms

Conditions

Myositis, Inclusion Body; Myotonic Dystrophy; Muscular Dystrophy, Facioscapulohumeral; Myasthenia Gravis

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Dystrophies; Muscular Disorders, Atrophic; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Neuromuscular Junction Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Sports and Movement Therapy

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: September 1, 2023
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)