Inclusion Body MyositisFBIndexNCT06605612
Development and Validation of the FBIndex to Determine the Risk of Falls 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
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inclusion Body Myositis, Myotonic Dystrophy, Limb-girdle and Facioscapulohumeral Muscular Dystrophies
- What is being tested?
- FBIndex
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2024to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 confirmed by the genetic report and/or clinical final diagnosis will be included in the study: inclusion body myositis, myotonic dystrophies, limb-girdle and facioscapulohumeral muscular dystrophies, Pompe disease, myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, spinal muscular atrophy, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, Friedreich-Ataxia, hereditary motor sensory neuropathy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Friedrich-Baur-Institut, Neurologische Klinik und Poliklinik, LMU Klinikum, Ludwig-Maximilians-Universität München
München, Bavaria, 80336
About this study
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.
Read the detailed description
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.
- Conditions
- Inclusion Body Myositis, Myotonic Dystrophy, Limb-girdle and Facioscapulohumeral Muscular Dystrophies, Pompe Disease, Myasthenia Gravis, Lambert-Eaton-Syndrome
- Being tested
- FBIndex
- Keywords
- Risk of falls, Neuromuscular Diseases, Neuromuscular Disorders, Risk of Falls Index, Assistive Gait Device
- Medical subject headings
- Myositis, Inclusion Body, Myotonic Dystrophy, Muscular Dystrophy, Facioscapulohumeral, Glycogen Storage Disease Type II, Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, Amyotrophic Lateral Sclerosis, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBIndexDiagnostic test
There will be no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Friedrich-Baur-Institute | All patients in group A will undergo single tests (cross-over design data):HRT, CRT, STS, FTT and TRT on the Leonardo Mechanograph® Ground Reaction Force Plate, assessing power and force data. Additionally, the time to perform the tests will be assessed manually. The 10MWT, 6MWT and TUG tests are performed without a ground reaction force plate and only time parameters are assessed. The group A will have an additional subgroup A1 of n=20 patients, which will be tested two times within two weeks to confirm intra-rater (n=10) and inter-rater reliability (n=10).No intervention will be carried out. Receives: Diagnostic Test: FBIndex | |
| Medical Park Bad Feilnbach | The group B will perform the same tests without using a force plate, assessing only the time parameters. No intervention will be carried out. Receives: Diagnostic Test: FBIndex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chair-Rise Test (CRT)
This is a sit-to-stand test with five repetitions. Three sets will be performed, and the fastest one will be scored. In Group A, the test uses a bench with a height of 46 cm anchored to the force plate.Only the best rise will be analyzed to collect force and power data. The main outcome parameter is the time required to perform the five repeat movements. In Group A, the examiner will assess the performance time of five sit-to-stand movements from the first to last repetition and the power data (Pmax rel. W/kg) from the force plate. In Group B, the examiner will only record the time taken to complete the test.
Measured: Immediately after the ICF is signed
Trunk Rise Test (TRT)
Participants slowly bend their knees with erect straight upper body until the fingertips touch their feet or lower leg on the inside and then cross the arms on their chest and grab their shoulders with their hands. The instructions will follow: "After the signal, rise as fast as possible, one time (movement compared to lifting a heavy object). You can use your arm to push yourself up on your thigh if you cannot get up without it". Three sets will be done, and the fastest result will be evaluated. In Groups A and B, the examiner will assess the performance time from the start position "forward bend 90°" to stand up straight and also assess whether participants use their arms or not to stand up straight. In Group A, time is assessed with power data (Pmax rel. W/kg) from the force plate. In Group B, the examiner will only record the time to perform the test on a solid concrete ground floor.
Measured: Immediately after the ICF is signed
Heel-Rise Test (HRT)
It consists of five bilateral maximal heel rises to achieve a maximal speed of upward movement. Three sets will be done, and the fastest result will be evaluated. The instructions will follow: "Rise to the tip of your toes five-times in a row as fast and high as possible. It is important that you keep your knees straight. Cross your arms on your chest and grab your shoulders with your hands. Move to your tiptoes as fast and high as possible." In Group A, the examiner will assess the performance time of five bilateral heel rises from first to last, along with the power data (P.max rel. kg- W/kg) from the force plate. In Group B, the examiner will only record the time to perform five bilateral heel rises from first to last tiptoes on a solid concrete ground floor.
Measured: Immediately after the ICF is signed
Semi-Tandem stand, eyes open (STSeo) and eyes closed (STSeo)
In this test, participants will be instructed to stand as still as possible in an upright position with both arms crossed in front of the upper body for starting, first with eyes open. Then eyes closed, in a Semi-Tandem stand as long as possible (for a maximum of 30 sec.). Three sets will be done. During the test, the Leonardo Mechanography system records the position of the center of pressure on the platform. In Group A, the time to the first drop or side-step is measured, up to a maximum of 30 seconds, together with power data (Ellip. Average cm) from the force plate. In Group B, the examiner records only the time to first drop or side-step, up to a maximum of 30 seconds. The Group B will do a semi-tandem stand on a solid concrete floor with a 1 cm wide line between the inside of the soles of the feet.
Measured: Immediately after the ICF is signed
Foot-Tapping Test (FTT) (sitting)
The FTT is designed to assess coordination and reaction time for the foot. Sitting on a 46 cm high bench, the participant\'s task is to tap ten times with the same foot (dorsal flexion, plantar flexion) as quickly as possible while keeping the heel on the ground. The participants were instructed to tap first with their right foot 10 times as quickly as possible. The same procedure will be repeated with the left feet, and three sets of left/right will be carried out. The participants need to sit straight, with 90° between the lower and upper leg and crossed arms over the chest. In Group A, the time for 10- foot tappings together with power data (max frequency and average contact time) from the force plate will be assessed. In Group B, the examiner records only the time. In Group B, participants are seated on a 46 cm high bench or chair with no backrest.
Measured: Immediately after the ICF is signed
10-Meter Walk Test
Walking at maximum speed will be measured in a long corridor with an even surface over 10 meters with a still-standing start and a "flying" finish to a target 2.5 meters beyond the 10 m mark. The stopwatch started with the word "Go" ("Ready-Steady-Go").
Measured: Immediately after the ICF is signed
Six-Minute Walk test
For the 6MWT, the individuals will be instructed to walk 30 m between two marks on the floor. After passing either mark, they will be told to turn and walk back. They will be instructed to walk as far as possible for six minutes and were allowed to rest (only while standing) and then to continue walking. They will be informed every minute of the remaining test time.
Measured: Immediately after the ICF is signed
Time Up and Go (TUG)
The TUG test measures the time it takes to stand up from a chair, walk three meters, turn around and sit down in the same chair. The subjects start with arm support from a seated position in a chair of normal height (44-45 cm) with arms, walk at a comfortable and safe pace to a mark on the floor 3 meters away, turn around, walk back to the chair, turn again and sit down. Time is measured from the start of the moment until participants touch the chair backrest with their back.
Measured: Immediately after the ICF is signed
Secondary outcomes (1)
The Falls Efficacy Scale-International (FES-I)
FES_I, a valid and reliable risk of fall scale used for different diagnoses, will be performed. The patient will carry out the FES-I independently. The FES-I is a scale used to measure fear of falling, self-efficacy, and balance confidence. It is suitable for use in research and clinical practice.
Measured: Immediately after the ICF is signed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start9 Sep 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Park AG
- Responsible party
- Principal investigator, Marko Mijic, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605612
- Sponsor's protocol ID
- 24-0636
- Other IDs
- 24-0636
- Acronym
- FBIndex
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946Dias N, Kempen GI, Todd CJ, Beyer N, Freiberger E, Piot-Ziegler C, Yardley L, Hauer K. [The German version of the Falls Efficacy Scale-International Version (FES-I)]. Z Gerontol Geriatr. 2006 Aug;39(4):297-300. doi: 10.1007/s00391-006-0400-8. German.
PubMed 16900450Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.
PubMed 16267188DiPaolo G, Jimenez-Moreno C, Nikolenko N, Atalaia A, Monckton DG, Guglieri M, Lochmuller H. Functional impairment in patients with myotonic dystrophy type 1 can be assessed by an ataxia rating scale (SARA). J Neurol. 2017 Apr;264(4):701-708. doi: 10.1007/s00415-017-8399-x. Epub 2017 Feb 6.
PubMed 28168524Murphy SM, Herrmann DN, McDermott MP, Scherer SS, Shy ME, Reilly MM, Pareyson D. Reliability of the CMT neuropathy score (second version) in Charcot-Marie-Tooth disease. J Peripher Nerv Syst. 2011 Sep;16(3):191-8. doi: 10.1111/j.1529-8027.2011.00350.x.
PubMed 22003934Runge M, Hunter G. Determinants of musculoskeletal frailty and the risk of falls in old age. J Musculoskelet Neuronal Interact. 2006 Apr-Jun;6(2):167-73.
PubMed 16849828Dharmadasa T, Matamala JM, Huynh W, Zoing MC, Kiernan MC. Chapter 22 - Motor neurone disease. In: Day BL, Lord SRBT-H of CN, editors. Balanc. Gait, Falls, vol. 159, Elsevier; 2018, p. 345-57. https://doi.org/https://doi.org/10.1016/B978-0-444-63916-5.00022-7.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the FBIndex to Determine the Risk of Falls for Patients With Neuromuscular Disorders
- ClinicalTrials.gov ID
- NCT06605612
- Acronym / sponsor ID
- FBIndex / 24-0636
- Conditions
- Inclusion Body Myositis, Myotonic Dystrophy, Limb-girdle and Facioscapulohumeral Muscular Dystrophies, Pompe Disease, Myasthenia Gravis, Lambert-Eaton-Syndrome
- Keywords
- Risk of falls, Neuromuscular Diseases, Neuromuscular Disorders, Risk of Falls Index, Assistive Gait Device
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- Medical Park AG
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 20 Sep 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Friedrich-Baur-Institute | – | Diagnostic Test: FBIndexAll patients in group A will undergo single tests (cross-over design data):HRT, CRT, STS, FTT and TRT on the Leonardo Mechanograph® Ground Reaction Force Plate, assessing power and force data. Additionally, the time to perform the tests will be assessed manually. The 10MWT, 6MWT and TUG tests are performed without a ground reaction force plate and only time parameters are assessed. The group A will have an additional subgroup A1 of n=20 patients, which will be tested two times within two weeks to confirm intra-rater (n=10) and inter-rater reliability (n=10).No intervention will be carried out. |
| Medical Park Bad Feilnbach | – | Diagnostic Test: FBIndexThe group B will perform the same tests without using a force plate, assessing only the time parameters. No intervention will be carried out. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Following neuromuscular diseases confirmed by the genetic report and/or clinical final diagnosis will be included in the study: inclusion body myositis, myotonic dystrophies, limb-girdle and facioscapulohumeral muscular dystrophies, Pompe disease, myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, spinal muscular atrophy, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, Friedreich-Ataxia, hereditary motor sensory neuropathy.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| FBIndexThere will be no intervention. | Diagnostic test | Friedrich-Baur-Institute, Medical Park Bad Feilnbach |
Primary outcome
Chair-Rise Test (CRT)
Time frame: Immediately after the ICF is signed
This is a sit-to-stand test with five repetitions. Three sets will be performed, and the fastest one will be scored. In Group A, the test uses a bench with a height of 46 cm anchored to the force plate.Only the best rise will be analyzed to collect force and power data. The main outcome parameter is the time required to perform the five repeat movements. In Group A, the examiner will assess the performance time of five sit-to-stand movements from the first to last repetition and the power data (Pmax rel. W/kg) from the force plate. In Group B, the examiner will only record the time taken to complete the test.
Trunk Rise Test (TRT)
Time frame: Immediately after the ICF is signed
Participants slowly bend their knees with erect straight upper body until the fingertips touch their feet or lower leg on the inside and then cross the arms on their chest and grab their shoulders with their hands. The instructions will follow: "After the signal, rise as fast as possible, one time (movement compared to lifting a heavy object). You can use your arm to push yourself up on your thigh if you cannot get up without it". Three sets will be done, and the fastest result will be evaluated. In Groups A and B, the examiner will assess the performance time from the start position "forward bend 90°" to stand up straight and also assess whether participants use their arms or not to stand up straight. In Group A, time is assessed with power data (Pmax rel. W/kg) from the force plate. In Group B, the examiner will only record the time to perform the test on a solid concrete ground floor.
Heel-Rise Test (HRT)
Time frame: Immediately after the ICF is signed
It consists of five bilateral maximal heel rises to achieve a maximal speed of upward movement. Three sets will be done, and the fastest result will be evaluated. The instructions will follow: "Rise to the tip of your toes five-times in a row as fast and high as possible. It is important that you keep your knees straight. Cross your arms on your chest and grab your shoulders with your hands. Move to your tiptoes as fast and high as possible." In Group A, the examiner will assess the performance time of five bilateral heel rises from first to last, along with the power data (P.max rel. kg- W/kg) from the force plate. In Group B, the examiner will only record the time to perform five bilateral heel rises from first to last tiptoes on a solid concrete ground floor.
Semi-Tandem stand, eyes open (STSeo) and eyes closed (STSeo)
Time frame: Immediately after the ICF is signed
In this test, participants will be instructed to stand as still as possible in an upright position with both arms crossed in front of the upper body for starting, first with eyes open. Then eyes closed, in a Semi-Tandem stand as long as possible (for a maximum of 30 sec.). Three sets will be done. During the test, the Leonardo Mechanography system records the position of the center of pressure on the platform. In Group A, the time to the first drop or side-step is measured, up to a maximum of 30 seconds, together with power data (Ellip. Average cm) from the force plate. In Group B, the examiner records only the time to first drop or side-step, up to a maximum of 30 seconds. The Group B will do a semi-tandem stand on a solid concrete floor with a 1 cm wide line between the inside of the soles of the feet.
Foot-Tapping Test (FTT) (sitting)
Time frame: Immediately after the ICF is signed
The FTT is designed to assess coordination and reaction time for the foot. Sitting on a 46 cm high bench, the participant\'s task is to tap ten times with the same foot (dorsal flexion, plantar flexion) as quickly as possible while keeping the heel on the ground. The participants were instructed to tap first with their right foot 10 times as quickly as possible. The same procedure will be repeated with the left feet, and three sets of left/right will be carried out. The participants need to sit straight, with 90° between the lower and upper leg and crossed arms over the chest. In Group A, the time for 10- foot tappings together with power data (max frequency and average contact time) from the force plate will be assessed. In Group B, the examiner records only the time. In Group B, participants are seated on a 46 cm high bench or chair with no backrest.
10-Meter Walk Test
Time frame: Immediately after the ICF is signed
Walking at maximum speed will be measured in a long corridor with an even surface over 10 meters with a still-standing start and a "flying" finish to a target 2.5 meters beyond the 10 m mark. The stopwatch started with the word "Go" ("Ready-Steady-Go").
Six-Minute Walk test
Time frame: Immediately after the ICF is signed
For the 6MWT, the individuals will be instructed to walk 30 m between two marks on the floor. After passing either mark, they will be told to turn and walk back. They will be instructed to walk as far as possible for six minutes and were allowed to rest (only while standing) and then to continue walking. They will be informed every minute of the remaining test time.
Time Up and Go (TUG)
Time frame: Immediately after the ICF is signed
The TUG test measures the time it takes to stand up from a chair, walk three meters, turn around and sit down in the same chair. The subjects start with arm support from a seated position in a chair of normal height (44-45 cm) with arms, walk at a comfortable and safe pace to a mark on the floor 3 meters away, turn around, walk back to the chair, turn again and sit down. Time is measured from the start of the moment until participants touch the chair backrest with their back.
1 secondary outcome
The Falls Efficacy Scale-International (FES-I)
Time frame: Immediately after the ICF is signed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 1991946Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- Results publication: PubMed 16900450Dias N, Kempen GI, Todd CJ, Beyer N, Freiberger E, Piot-Ziegler C, Yardley L, Hauer K. [The German version of the Falls Efficacy Scale-International Version (FES-I)]. Z Gerontol Geriatr. 2006 Aug;39(4):297-300. doi: 10.1007/s00391-006-0400-8. German.
- Results publication: PubMed 16267188Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.
- Results publication: PubMed 28168524DiPaolo G, Jimenez-Moreno C, Nikolenko N, Atalaia A, Monckton DG, Guglieri M, Lochmuller H. Functional impairment in patients with myotonic dystrophy type 1 can be assessed by an ataxia rating scale (SARA). J Neurol. 2017 Apr;264(4):701-708. doi: 10.1007/s00415-017-8399-x. Epub 2017 Feb 6.
- Results publication: PubMed 22003934Murphy SM, Herrmann DN, McDermott MP, Scherer SS, Shy ME, Reilly MM, Pareyson D. Reliability of the CMT neuropathy score (second version) in Charcot-Marie-Tooth disease. J Peripher Nerv Syst. 2011 Sep;16(3):191-8. doi: 10.1111/j.1529-8027.2011.00350.x.
- Results publication: PubMed 16849828Runge M, Hunter G. Determinants of musculoskeletal frailty and the risk of falls in old age. J Musculoskelet Neuronal Interact. 2006 Apr-Jun;6(2):167-73.
- Results publicationDharmadasa T, Matamala JM, Huynh W, Zoing MC, Kiernan MC. Chapter 22 - Motor neurone disease. In: Day BL, Lord SRBT-H of CN, editors. Balanc. Gait, Falls, vol. 159, Elsevier; 2018, p. 345-57. https://doi.org/https://doi.org/10.1016/B978-0-444-63916-5.00022-7.
- Individual participant dataSharing planned: Undecided. Undecided: It is not yet known if there will be a plan to make IPD available.
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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.
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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 10 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Chair-Rise Test (CRT) (time frame: Immediately after the ICF is signed). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06605612, which also lists 7 linked publications.
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 10 Sep 2025.