ClinicalTrials.gov record NCT06605612
Development and Validation of the FBIndex to Determine the Risk of Falls for Patients With Neuromuscular Disorders
Development and Validation of the FBIndex to Determine the Risk of Falls for Patients With Neuromuscular Disorders
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This retrospective observational study uses existing and collected clinical test data to develop and validate the Friedrich‑Baur Risk of Fall Index (FBIndex). It analyzes timed and force-plate versions of short muscle and gait tests (for example Heel‑Rise, Chair‑Rise, Semi‑tandem stand, Trunk‑Rise, Foot‑Tapping, Timed Up and Go, 10‑m and 6‑min walk) across people with various neuromuscular disorders and compares them with healthy norm data. The study also evaluates intra‑ and inter‑rater and test‑retest reliability of the included assessments.
What it is studying. Whether a defined battery of short muscle and walking tests can be validated and generalized across different neuromuscular disorders to determine risk of falling, and whether time-only measurements reproduce force-plate results so the FBIndex can be used without force-plate equipment. The study also assesses observer reliability and compares patient results with healthy norm data.
What the researchers hope to learn. Scientific goals: validate and generalize the FBIndex across multiple neuromuscular disorders; determine whether time-only test scores reflect force-plate measures; establish intra‑ and inter‑rater and test‑retest reliability for the included assessments; and compare patient data with healthy norms.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Currently, there are no standardised fall risk scores or guidelines on when to use appropriate assistive gait devices (AGDs) for people with neuromuscular disorders (NMDs). There is a clear medical unmet need to provide a battery of appropriate locomotor gait assessments to determine the risk of falling for patients with NMDs and give clear guidelines to prescribe an appropriate AGD. The primary goal is to confirm whether the clinical battery assessments (Heel-Rise Test (HRT), Chair-Rise Test (CRT), Semi-tandem Stand (STS), Trunk-Rise Test (TRT), Foot-Tapping Test (FTT), Timed Up and Go (TUG), 10-Meter-Walk Test (10MWT) and 6-Minute-Walk Test (6MWT) can be validated and generalized to other NMD target populations that meet broader eligibility criteria based on used clinical assessments. The second objective of this project is to provide intra- and inter-observer reliability and test-retest reliability of included clinical assessments used to determine the risk of falling for patients with NMDs. Finally, all data will be compared with norm data from the healthy population (n=15) collected retrospectively.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Diagnostic test
- FBIndex
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Only patients with adequate cognitive and communicative function to give informed consent and to fill out the scale assessing the risk of falling will be included.
Exclusion criteria
- Patients who are unable to walk without AGD for at least 10 meters.
- Patients who had knee, hip or back surgery in the last three months.
- Patients who suffer from polyneuropathy or peripheral neuropathy.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
The NMD people are characterised by a complex muscle weakness caused by a combination of different factors. These include reduced endurance, lack of explosive muscle force and power, intramuscular strength coordination, and reduced balance. Those parameters need to be considered when developing an appropriate fall risk score. The combination of short muscular function and balance assessments with short clinical scores, can be a new, valid approach to evaluating the patient's risk of falling. In addition, it assists in creating a quick checkup for prescribing an appropriate assistive device. In the first part (feasibility study) of this project, the following force plate tests were identified as suitable to assess muscle power, force and balance variables: Heel-Rise Test (HRT), Chair-Rise Test (CRT), Semi-tandem Stand (STS), Trunk-Rise Test (TRT), Foot-Tapping Test (FTT). They were used as predictors to assess patients muscle weakness and disability. In addition to muscle power and force data collected on the force plate, a second rater manually evaluated the time required to perform this test using a stopwatch. Additionally, three separate tests, Timed Up and Go (TUG), 10-Meter-Walk Test (10MWT) and 6-Minute-Walk Test (6MWT), have been evaluated separately as standard care procedures. The TUG, 10MWT and 6MWT have been used to assess remaining motor skills (endurance, walking speed and coordination) that cannot be covered by HRT, CRT, STS, TRT and FTT. As a third parameter used for correlation analysis, two risk of fall scales, Falls Efficacy Scale International (FES-I) and Morse Fall Scale (MFS), have been used. The found data from the feasibility study, which is planned to be published, suggest a moderate to moderate to strong correlation between HRT, CRT, STS, TRT, FTT, TUG, 10MWT and 6MWT and the FES-I and will be used in in the follow-up study. The MFS was excluded from the final test battery due to a lack of correlation with dependent variables. Moreover, the dependent variables assessed on the force plate, HRT, CRT, STS, TRT, and FTT (power and force), were correlated with variables collected by performing the same test using only manual time. Applying muscle strength and power data on the force plate was necessary to confirm internal consistency, content and criterion validity, as well as the degree to which the HRT, CRT, STS, TRT and FTT test can be an adequate reflection of the same test data using only manual time variables, as the final Friedrich-Baur Risk of Fall Index (FBIndex) should be conducted without the force plate using only time variables. This study decided to include more patients and more different neuromuscular diseases to assess a wider range of muscle weaknesses that can lead to falls. Moreover, the final test battery was defined, and the standardised methodological procedure was established. Using regression and discrimination analysis, the cross-sectional construct validity of a priori hypotheses: "Is there a multiple correlation between HRT, CRT, STS, TRT, FTT, TUG, 10MWT and 6MWT with FES-I?" will be tested.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving informed consent, participants complete the Falls Efficacy Scale‑International questionnaire and then perform a set of timed physical tests. Tests include Chair‑Rise, Trunk‑Rise, Heel‑Rise, Semi‑Tandem stand, Foot‑Tapping (sitting), Timed Up and Go, 10‑meter walk, and the six‑minute walk; many tests are done in three sets and the best/faster result is used. In one study group these tests are recorded on a Leonardo Mechanograph® ground reaction force plate to collect muscle power and force data; in the other group the same tests are measured only by manual timing on the floor or chair. About 20 participants will be asked to repeat testing within two weeks to assess test reliability; no medical treatments or invasive procedures are performed.
How the study is structured. A retrospective cohort observational study comparing two groups of test data. Group A includes tests recorded on a force plate (Heel‑Rise, Chair‑Rise, Semi‑tandem stand, Trunk‑Rise, Foot‑Tapping) plus timed TUG, 10‑m and 6‑min walk tests; Group B performs the same tests without a force plate (time only). A subgroup in Group A is re‑tested within two weeks to check intra‑ and inter‑rater and test‑retest reliability. No medical interventions are given; collected data are analyzed to develop and validate the FBIndex.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Pompe disease
This trial is also listed on this site under Friedreich ataxia.
Important dates
- Study start
- Sep 9, 2024
- Primary completion
- Aug 1, 2027 (estimated)
- Study completion
- Jan 1, 2028 (estimated)
- Target enrollment
- 108 participants (estimated)
- Last updated on registry
- Sep 10, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- LMU Klinikum
- Principal investigator
- Marko Mijic, Scientific Worker (dr. rer. biol. hum.)
LMU Klinikum - Collaborators
- Medical Park AG
Participating sites (1)
- Friedrich-Baur-Institut, Neurologische Klinik und Poliklinik, LMU Klinikum, Ludwig-Maximilians-Universität München
München, Bavaria, 80336 · Germany
Terms used on this page · explanations by MedicalUpdates.ai
- 6MWT
- A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
- eligibility criteria
- The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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