The Risk of Falls Index for Patients With Neuromuscular Disorders

Recruiting

• Conditions: Inclusion Body Myositis; Myotonic Dystrophy; Facioscapulohumeral Muscular Dystrophies; The Morse Fall Scale; Myasthenia Gravis; The Falls Efficacy Scale International
• Interventions: Diagnostic Test: The risk of falls

• Registration Number: NCT05890833
• Lead Sponsor: LMU Klinikum

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-06
• Study Start: 2023-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neuromuscular disorders	The risk of falls	-

Primary Outcome Measures

Name	Time	Method
FBIndex	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.

Trial Locations

Locations (1)

Marko Mijic; 🇩🇪 München, Bavaria, Germany