The Risk of Falls Index for Patients With Neuromuscular Disorders

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890833
• Other study ID #: FBIndex_80336
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2023
• Source: LMU Klinikum
• Contact: Marko Mijic
• Phone: +4989440057078
• Email: marko.mijic[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inclusion Body Myositis
• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral
• Myasthenia Gravis
• Myositis
• Myositis, Inclusion Body
• Myotonic Dystrophy
• Neuromuscular Diseases

Intervention

Diagnostic Test:
• The risk of falls
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.

Locations

Country	Name	City	State
Germany	Marko Mijic	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
LMU Klinikum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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