The Risk of Falls Index for Patients With Neuromuscular Disorders

NCT05890833 — Completed, 30 participants, LMU Klinikum

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

Registry	NCT05890833
Status	Completed
Study type	Observational
Enrollment	30 (Actual)
Sponsor	LMU Klinikum (Other)
Conditions	Inclusion Body Myositis, Myotonic Dystrophy, Facioscapulohumeral Muscular Dystrophies, Myasthenia Gravis, The Falls Efficacy Scale International, The Morse Fall Scale
Interventions	The risk of falls (Diagnostic test)
Dates	start 2023-09-01, primary completion 2024-09-09, completion 2024-09-09, first posted 2023-06-06, last updated 2024-09-19
Locations	1 site in Germany

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Neuromuscular disorders		Diagnostic Test: The risk of falls

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.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
Marko Mijic	München, Bavaria	Germany