Myotonic Dystrophy Type 1NCT07493525
Fall Frequency and Factors Affecting Dynamic Balance in Patients With Myotonic Dystrophy Type 1
An observational study of Myotonic Dystrophy Type 1 and Falls, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study aims to determine the frequency of falls in patients with myotonic dystrophy type 1 and to identify factors affecting dynamic balance. The study will also evaluate fear of falling, selected lower extremity muscle strength, and the relationship between muscle strength and fall… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myotonic Dystrophy Type 1, Falls
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2025to 15 Jun 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will consist of adult patients with myotonic dystrophy type 1 who are followed at the Neuromuscular Diseases Center of Antalya Training and Research Hospital. Participants who meet the predefined eligibility criteria and are able to complete the balance, mobility, and muscle strength assessments will be included.
Who may be able to join
- Adults aged between 18 and 60 years old
- Diagnosis of myotonic dystrophy type 1
- Ability to understand and follow study instructions
- Ability to ambulate, with or without an assistive device, sufficiently to perform the study assessments
- Willingness to participate and provide written informed consent
Who cannot join
- Severe cognitive impairment interfering with understanding or completion of the study assessments
- Severe visual impairment interfering with balance and mobility testing
- Severe sensory impairment, including markedly impaired vibration sensation, that may affect balance assessment
- Any additional neurological, musculoskeletal, vestibular, or other medical condition that could substantially affect gait, balance, or fall risk independently of myotonic dystrophy type 1
- Acute medical condition or unstable clinical status at the time of assessment
- Inability to complete the study evaluations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, Antalya, 07100
About this study
Official title: Determination of Fall Frequency and Factors Affecting Dynamic Balance in Patients With Myotonic Dystrophy Type 1: A Cross-Sectional Observational Single-Center Study
This cross-sectional observational study aims to determine the frequency of falls in patients with myotonic dystrophy type 1 and to identify factors affecting dynamic balance. The study will also evaluate fear of falling, selected lower extremity muscle strength, and the relationship between muscle strength and fall frequency. The findings may contribute to a better understanding of fall risk and balance impairment in patients with myotonic dystrophy type 1.
Read the detailed description
Myotonic dystrophy type 1 is a multisystem neuromuscular disorder characterized by myotonia, progressive muscle weakness, and functional limitations. Distal muscle weakness, impaired postural control, and gait dysfunction may increase the risk of falls and negatively affect daily activities and quality of life. Although falls and balance impairment are clinically important in patients with myotonic dystrophy type 1, data on fall frequency and factors affecting dynamic balance remain limited.
This single-center, hospital-based, cross-sectional observational study will be conducted in patients with myotonic dystrophy type 1 who are followed at the Neuromuscular Diseases Center of Antalya Training and Research Hospital. The study aims to determine fall frequency and to investigate factors affecting dynamic balance. Fear of falling, lower extremity muscle strength, and dynamic balance performance will be assessed, and the relationship between muscle strength and fall frequency will be examined. The results are expected to improve the understanding of fall-related impairments in myotonic dystrophy type 1 and support more comprehensive clinical assessment and rehabilitation planning.
- Conditions
- Myotonic Dystrophy Type 1, Falls
- Keywords
- dynamic balance, falls, fall frequency, fear of falling, muscle strenght, neuromuscular disease, postural control, gait, balance impairment, rehabilitation
- Medical subject headings
- Myotonic Dystrophy, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myotonic Dystrophy Type 1 Group | Patients with myotonic dystrophy type 1 who are evaluated for fall frequency, dynamic balance, fear of falling, and lower extremity muscle strength. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall frequency
Fall frequency will be assessed using semi-structured questions regarding the number of falls experienced by patients with myotonic dystrophy type 1.
Measured: At baseline
Secondary outcomes (8)
Fear of falling
Fear of falling will be assessed using semi-structured questions regarding the fear of falling experienced by patients with myotonic dystrophy type 1.
Measured: At baseline
Muscular Impairment Rating Scale score
Disease-related muscle involvement severity will be assessed using the Muscular Impairment Rating Scale (MIRS).
Measured: At baseline
Dynamic balance performance by Timed Up and Go test
Dynamic balance performance will be assessed using the Timed Up and Go (TUG) test.
Measured: At baseline
Walking performance by 10-Meter Walk Test at maximum safe speed
Walking performance and dynamic mobility will be assessed using the 10-Meter Walk Test at maximum safe speed.
Measured: At baseline
Isometric muscle strength
Isometric muscle strength of selected muscle groups will be measured to evaluate the relationship between muscle strength and fall frequency.
Measured: At baseline
Hand grip strength
Hand grip strength will be measured using a hand grip strength assessment.
Measured: At baseline
Balance performance by Berg Balance Scale
Balance performance will be evaluated using the Berg Balance Scale.
Measured: At baseline
Functional Ambulation Scale score
Ambulation level will be recorded using the Functional Ambulation Scale (FAS).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start20 Jun 2025
- Primary completion15 Oct 2025
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Myotonic Dystrophy Type 1Studies 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
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ceren Arslan, Antalya Training and Research Hospital
- Investigators
- Hanife Hale Hekim, MD, Study chair, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493525
- Sponsor's protocol ID
- 2025-217
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet made a final decision regarding the sharing of individual participant data. Any future data sharing will be considered in accordance with institutional policies, ethics committee approval, and participant confidentiality requirements.
Publications
Berends J, Tieleman AA, Horlings CGC, Smulders FHP, Voermans NC, van Engelen BGM, Raaphorst J. High incidence of falls in patients with myotonic dystrophy type 1 and 2: A prospective study. Neuromuscul Disord. 2019 Oct;29(10):758-765. doi: 10.1016/j.nmd.2019.08.012. Epub 2019 Aug 28.
PubMed 31540818Hammaren E, Kjellby-Wendt G, Kowalski J, Lindberg C. Factors of importance for dynamic balance impairment and frequency of falls in individuals with myotonic dystrophy type 1 - a cross-sectional study - including reference values of Timed Up & Go, 10m walk and step test. Neuromuscul Disord. 2014 Mar;24(3):207-15. doi: 10.1016/j.nmd.2013.12.003. Epub 2013 Dec 15.
PubMed 24412157Jimenez-Moreno AC, Raaphorst J, Babacic H, Wood L, van Engelen B, Lochmuller H, Schoser B, Wenninger S. Falls and resulting fractures in Myotonic Dystrophy: Results from a multinational retrospective survey. Neuromuscul Disord. 2018 Mar;28(3):229-235. doi: 10.1016/j.nmd.2017.12.010. Epub 2017 Dec 27.
PubMed 29361394Wiles CM, Busse ME, Sampson CM, Rogers MT, Fenton-May J, van Deursen R. Falls and stumbles in myotonic dystrophy. J Neurol Neurosurg Psychiatry. 2006 Mar;77(3):393-6. doi: 10.1136/jnnp.2005.066258. Epub 2005 Sep 30.
PubMed 16199443Pieterse AJ, Luttikhold TB, de Laat K, Bloem BR, van Engelen BG, Munneke M. Falls in patients with neuromuscular disorders. J Neurol Sci. 2006 Dec 21;251(1-2):87-90. doi: 10.1016/j.jns.2006.09.008. Epub 2006 Nov 9.
PubMed 17097113Schoene D, Heller C, Aung YN, Sieber CC, Kemmler W, Freiberger E. A systematic review on the influence of fear of falling on quality of life in older people: is there a role for falls? Clin Interv Aging. 2019 Apr 24;14:701-719. doi: 10.2147/CIA.S197857. eCollection 2019.
PubMed 31190764Trombetti A, Reid KF, Hars M, Herrmann FR, Pasha E, Phillips EM, Fielding RA. Age-associated declines in muscle mass, strength, power, and physical performance: impact on fear of falling and quality of life. Osteoporos Int. 2016 Feb;27(2):463-71. doi: 10.1007/s00198-015-3236-5. Epub 2015 Jul 21.
PubMed 26194491Kierkegaard M, Petitclerc E, Hebert LJ, Mathieu J, Gagnon C. Responsiveness of performance-based outcome measures for mobility, balance, muscle strength and manual dexterity in adults with myotonic dystrophy type 1. J Rehabil Med. 2018 Feb 28;50(3):269-277. doi: 10.2340/16501977-2304.
PubMed 29260836Hammaren E, Kollen L. What Happened with Muscle Force, Dynamic Stability And Falls? A 10-Year Longitudinal Follow-Up in Adults with Myotonic Dystrophy Type 1. J Neuromuscul Dis. 2021;8(6):1007-1016. doi: 10.3233/JND-200521.
PubMed 34151851Hammaren E, Kjellby-Wendt G, Lindberg C. Muscle force, balance and falls in muscular impaired individuals with myotonic dystrophy type 1: a five-year prospective cohort study. Neuromuscul Disord. 2015 Feb;25(2):141-8. doi: 10.1016/j.nmd.2014.11.004. Epub 2014 Nov 13.
PubMed 25475393Bachasson D, Moraux A, Ollivier G, Decostre V, Ledoux I, Gidaro T, Servais L, Behin A, Stojkovic T, Hebert LJ, Puymirat J, Eymard B, Bassez G, Hogrel JY. Relationship between muscle impairments, postural stability, and gait parameters assessed with lower-trunk accelerometry in myotonic dystrophy type 1. Neuromuscul Disord. 2016 Jul;26(7):428-35. doi: 10.1016/j.nmd.2016.05.009. Epub 2016 May 12.
PubMed 27234310
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Fall Frequency and Factors Affecting Dynamic Balance in Patients With Myotonic Dystrophy Type 1: A Cross-Sectional Observational Single-Center Study
- ClinicalTrials.gov ID
- NCT07493525
- Acronym / sponsor ID
- 2025-217
- Conditions
- Myotonic Dystrophy Type 1, Falls
- Keywords
- dynamic balance, falls, fall frequency, fear of falling, muscle strenght, neuromuscular disease, postural control, gait
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 25 Mar 2026 (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.
This cross-sectional observational study aims to determine the frequency of falls in patients with myotonic dystrophy type 1 and to identify factors affecting dynamic balance. The study will also evaluate fear of falling, selected lower extremity muscle strength, and the relationship between muscle strength and fall frequency. The findings may contribute to a better understanding of fall risk and balance impairment in patients with myotonic dystrophy type 1.
Detailed description
Myotonic dystrophy type 1 is a multisystem neuromuscular disorder characterized by myotonia, progressive muscle weakness, and functional limitations. Distal muscle weakness, impaired postural control, and gait dysfunction may increase the risk of falls and negatively affect daily activities and quality of life. Although falls and balance impairment are clinically important in patients with myotonic dystrophy type 1, data on fall frequency and factors affecting dynamic balance remain limited.
This single-center, hospital-based, cross-sectional observational study will be conducted in patients with myotonic dystrophy type 1 who are followed at the Neuromuscular Diseases Center of Antalya Training and Research Hospital. The study aims to determine fall frequency and to investigate factors affecting dynamic balance. Fear of falling, lower extremity muscle strength, and dynamic balance performance will be assessed, and the relationship between muscle strength and fall frequency will be examined. The results are expected to improve the understanding of fall-related impairments in myotonic dystrophy type 1 and support more comprehensive clinical assessment and rehabilitation planning.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myotonic Dystrophy Type 1 Group | – | –Patients with myotonic dystrophy type 1 who are evaluated for fall frequency, dynamic balance, fear of falling, and lower extremity muscle strength. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of adult patients with myotonic dystrophy type 1 who are followed at the Neuromuscular Diseases Center of Antalya Training and Research Hospital. Participants who meet the predefined eligibility criteria and are able to complete the balance, mobility, and muscle strength assessments will be included.
Key inclusion criteria (5 listed)
- Adults aged between 18 and 60 years old
- Diagnosis of myotonic dystrophy type 1
- Ability to understand and follow study instructions
- Ability to ambulate, with or without an assistive device, sufficiently to perform the study assessments
- Willingness to participate and provide written informed consent
Key exclusion criteria (6 listed)
- Severe cognitive impairment interfering with understanding or completion of the study assessments
- Severe visual impairment interfering with balance and mobility testing
- Severe sensory impairment, including markedly impaired vibration sensation, that may affect balance assessment
- Any additional neurological, musculoskeletal, vestibular, or other medical condition that could substantially affect gait, balance, or fall risk independently of myotonic dystrophy type 1
- Acute medical condition or unstable clinical status at the time of assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fall frequency
Time frame: At baseline
Fall frequency will be assessed using semi-structured questions regarding the number of falls experienced by patients with myotonic dystrophy type 1.
8 secondary outcomes
Fear of falling
Time frame: At baseline
Muscular Impairment Rating Scale score
Time frame: At baseline
Dynamic balance performance by Timed Up and Go test
Time frame: At baseline
Walking performance by 10-Meter Walk Test at maximum safe speed
Time frame: At baseline
Isometric muscle strength
Time frame: At baseline
Hand grip strength
Time frame: At baseline
Balance performance by Berg Balance Scale
Time frame: At baseline
Functional Ambulation Scale score
Time frame: At baseline
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 25 Mar 2026.
- Background: PubMed 31540818Berends J, Tieleman AA, Horlings CGC, Smulders FHP, Voermans NC, van Engelen BGM, Raaphorst J. High incidence of falls in patients with myotonic dystrophy type 1 and 2: A prospective study. Neuromuscul Disord. 2019 Oct;29(10):758-765. doi: 10.1016/j.nmd.2019.08.012. Epub 2019 Aug 28.
- Background: PubMed 24412157Hammaren E, Kjellby-Wendt G, Kowalski J, Lindberg C. Factors of importance for dynamic balance impairment and frequency of falls in individuals with myotonic dystrophy type 1 - a cross-sectional study - including reference values of Timed Up & Go, 10m walk and step test. Neuromuscul Disord. 2014 Mar;24(3):207-15. doi: 10.1016/j.nmd.2013.12.003. Epub 2013 Dec 15.
- Background: PubMed 29361394Jimenez-Moreno AC, Raaphorst J, Babacic H, Wood L, van Engelen B, Lochmuller H, Schoser B, Wenninger S. Falls and resulting fractures in Myotonic Dystrophy: Results from a multinational retrospective survey. Neuromuscul Disord. 2018 Mar;28(3):229-235. doi: 10.1016/j.nmd.2017.12.010. Epub 2017 Dec 27.
- Background: PubMed 16199443Wiles CM, Busse ME, Sampson CM, Rogers MT, Fenton-May J, van Deursen R. Falls and stumbles in myotonic dystrophy. J Neurol Neurosurg Psychiatry. 2006 Mar;77(3):393-6. doi: 10.1136/jnnp.2005.066258. Epub 2005 Sep 30.
- Background: PubMed 17097113Pieterse AJ, Luttikhold TB, de Laat K, Bloem BR, van Engelen BG, Munneke M. Falls in patients with neuromuscular disorders. J Neurol Sci. 2006 Dec 21;251(1-2):87-90. doi: 10.1016/j.jns.2006.09.008. Epub 2006 Nov 9.
- Background: PubMed 31190764Schoene D, Heller C, Aung YN, Sieber CC, Kemmler W, Freiberger E. A systematic review on the influence of fear of falling on quality of life in older people: is there a role for falls? Clin Interv Aging. 2019 Apr 24;14:701-719. doi: 10.2147/CIA.S197857. eCollection 2019.
- Background: PubMed 26194491Trombetti A, Reid KF, Hars M, Herrmann FR, Pasha E, Phillips EM, Fielding RA. Age-associated declines in muscle mass, strength, power, and physical performance: impact on fear of falling and quality of life. Osteoporos Int. 2016 Feb;27(2):463-71. doi: 10.1007/s00198-015-3236-5. Epub 2015 Jul 21.
- Background: PubMed 29260836Kierkegaard M, Petitclerc E, Hebert LJ, Mathieu J, Gagnon C. Responsiveness of performance-based outcome measures for mobility, balance, muscle strength and manual dexterity in adults with myotonic dystrophy type 1. J Rehabil Med. 2018 Feb 28;50(3):269-277. doi: 10.2340/16501977-2304.
- Background: PubMed 34151851Hammaren E, Kollen L. What Happened with Muscle Force, Dynamic Stability And Falls? A 10-Year Longitudinal Follow-Up in Adults with Myotonic Dystrophy Type 1. J Neuromuscul Dis. 2021;8(6):1007-1016. doi: 10.3233/JND-200521.
- Background: PubMed 25475393Hammaren E, Kjellby-Wendt G, Lindberg C. Muscle force, balance and falls in muscular impaired individuals with myotonic dystrophy type 1: a five-year prospective cohort study. Neuromuscul Disord. 2015 Feb;25(2):141-8. doi: 10.1016/j.nmd.2014.11.004. Epub 2014 Nov 13.
- Background: PubMed 27234310Bachasson D, Moraux A, Ollivier G, Decostre V, Ledoux I, Gidaro T, Servais L, Behin A, Stojkovic T, Hebert LJ, Puymirat J, Eymard B, Bassez G, Hogrel JY. Relationship between muscle impairments, postural stability, and gait parameters assessed with lower-trunk accelerometry in myotonic dystrophy type 1. Neuromuscul Disord. 2016 Jul;26(7):428-35. doi: 10.1016/j.nmd.2016.05.009. Epub 2016 May 12.
- Individual participant dataSharing planned: Undecided. The investigators have not yet made a final decision regarding the sharing of individual participant data. Any future data sharing will be considered in accordance with institutional policies, ethics committee approval, and participant confidentiality requirements.
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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.
Hanife Hale Hekim, MD study chair
Antalya Training and Research Hospital
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 Myotonic Dystrophy Type 1 and Falls, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. 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 Turkey (Türkiye). 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?
Fall frequency (time frame: At baseline). 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 NCT07493525, which also lists 11 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 25 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.