Inclusion Body MyositisNCT05890833
The Risk of Falls Index for Patients With Neuromuscular Disorders
An observational study of Inclusion Body Myositis and Myotonic Dystrophy, run by LMU Klinikum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inclusion Body Myositis, Myotonic Dystrophy, Facioscapulohumeral Muscular Dystrophies
- What is being tested?
- The risk of falls
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to 9 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Following neuromuscular diseases are included in the study: inclusion body myositis, myotonic dystrophies, limb girdle and facioscapulohumeral muscular dystrophies, and myasthenia gravis.
Who may be able to join
- 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.
Who cannot join
- Patients which are not able to perform motoric functional assessments without assistive gait device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The FBIndex to Determine the Risk of Falls and Its Translation to Assistive Gait Device Care for Patients With Neuromuscular Disorders
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.
- Conditions
- Inclusion Body Myositis, Myotonic Dystrophy, Facioscapulohumeral Muscular Dystrophies, Myasthenia Gravis, The Falls Efficacy Scale International, The Morse Fall Scale
- Being tested
- The risk of falls
- Medical subject headings
- Myositis, Inclusion Body, Myotonic Dystrophy, Muscular Dystrophy, Facioscapulohumeral, Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The risk of fallsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular disorders | Not described Receives: Diagnostic Test: The risk of falls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Sep 2023
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inclusion Body MyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Mijic, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890833
- Sponsor's protocol ID
- FBIndex_80336
- Status last verified
- Sep 2024
- First submitted
- 26 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FBIndex to Determine the Risk of Falls and Its Translation to Assistive Gait Device Care for Patients With Neuromuscular Disorders
- ClinicalTrials.gov ID
- NCT05890833
- Acronym / sponsor ID
- FBIndex_80336
- Conditions
- Inclusion Body Myositis, Myotonic Dystrophy, Facioscapulohumeral Muscular Dystrophies, Myasthenia Gravis, The Falls Efficacy Scale International, The Morse Fall Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular disorders | – | Diagnostic Test: The risk of falls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Following neuromuscular diseases are included in the study: inclusion body myositis, myotonic dystrophies, limb girdle and facioscapulohumeral muscular dystrophies, and myasthenia gravis.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients which are not able to perform motoric functional assessments without assistive gait device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The risk of fallsHeel-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. | Diagnostic test | Neuromuscular disorders |
Primary outcome
FBIndex
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inclusion Body Myositis and Myotonic Dystrophy, run by LMU Klinikum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FBIndex (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.