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

Study acronym: FBIndex
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Aug 1, 2025 to Aug 1, 2027
    • Study completion date: Jan 1, 2026 to Jan 1, 2028
    • Publications: details revised at 6 of 7 entries
    v3
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06605612
Lead Sponsor LMU Klinikum
Collaborators: Medical Park AG
Conditions
(from sponsor)		 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
Related terms Amyotrophic Lateral Sclerosis, Friedreich Ataxia, Glycogen Storage Disease Type II, Guillain-Barre Syndrome, Hereditary Sensory and Motor Neuropathy, Lambert-Eaton Myasthenic Syndrome, Muscular Atrophy, Spinal, Muscular Dystrophy, Facioscapulohumeral, Myasthenia Gravis, Myositis, Inclusion Body, Myotonic Dystrophy, Neuromuscular Diseases, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov