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CompletedNCT05890833Updated Sep 19, 2024

The Risk of Falls Index for Patients With Neuromuscular Disorders

An observational study in Inclusion Body Myositis, Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophies, sponsored by LMU Klinikum. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by LMU Klinikum · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Inclusion Body Myositis
  • Myotonic Dystrophy
  • Facioscapulohumeral Muscular Dystrophies
  • Myasthenia Gravis
  • The Falls Efficacy Scale International
  • The Morse Fall Scale
03

In context

Myositis, Inclusion Body

51 studies on the registry are indexed under Myositis, Inclusion Body; 11 are open to participants now.

This study's enrollment of 30 is below the median of 64 across 18 observational studies indexed under Myositis, Inclusion Body.

Browse Myositis, Inclusion Body studies →

Lead sponsor

LMU Klinikum is the lead sponsor of 53 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Neuromuscular disorders

    Diagnostic Test: The risk of falls

Interventions

  • Diagnostic testThe 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.

06

What researchers measure

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.

    Time frame: 2 years

07

Study locations

1 site
  • Marko Mijic
    München, Bavaria 80336, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2023 to primary completion in Sep 2024, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 26, 2023
First posted
Jun 6, 2023
StartActual
Sep 1, 2023
Primary completionActual
Sep 9, 2024
CompletionActual
Sep 9, 2024
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05890833
Lead sponsor
LMU Klinikum
Responsible party
Marko Mijic (Master of Sports and Movement Therapy, LMU Klinikum) — Principal investigator
First posted
Jun 6, 2023
Start date
Sep 1, 2023
Primary completion
Sep 9, 2024
Completion
Sep 9, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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