Development and Validation of the FBIndex to Determine the Risk of Falls for Patients With Neuromuscular Disorders

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.

NCT Number	NCT06605612
Lead Sponsor	LMU Klinikum Collaborators: Medical Park AG
Conditions	Inclusion Body Myositis, Myotonic Dystrophy, Limb-girdle and Facioscapulohumeral Muscular Dystrophies, Pompe Disease, Myasthenia Gravis, Lambert-Eaton-Syndrome, Amyotrophic Lateral Sclerosis, Spinal Muscular Atrophy +4 more
Enrollment	108 participants
Start Date	2024-09-09
Primary Completion	2027-08-01 (estimated)
Study Completion	2028-01-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-10