Fall Frequency and Factors Affecting Dynamic Balance in Patients With Myotonic Dystrophy Type 1

NCT07493525 | Active Not Recruiting

• 1 other identifier: 2025-217
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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 frequency. The findings may contribute to a better understanding of fall risk and balance impairment in patients with myotonic dystrophy type 1.

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

Outcome Measures

Primary Outcomes (1)

• Fall frequency

  Fall frequency will be assessed using semi-structured questions regarding the number of falls experienced by patients with myotonic dystrophy type 1.

  At baseline

Secondary Outcomes (8)

• Fear of falling

  At baseline

• Muscular Impairment Rating Scale score

  At baseline

• Dynamic balance performance by Timed Up and Go test

  At baseline

• Walking performance by 10-Meter Walk Test at maximum safe speed

  At baseline

• Isometric muscle strength

  At baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 31540818 BACKGROUND

• Hammaren 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.

  PMID: 24412157 BACKGROUND

• Jimenez-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.

  PMID: 29361394 BACKGROUND

• Wiles 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.

  PMID: 16199443 BACKGROUND

• Pieterse 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.

  PMID: 17097113 BACKGROUND

• Schoene 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.

  PMID: 31190764 BACKGROUND

• Trombetti 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.

  PMID: 26194491 BACKGROUND

• Kierkegaard 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.

  PMID: 29260836 BACKGROUND

• Hammaren 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.

  PMID: 34151851 BACKGROUND

• Hammaren 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.

  PMID: 25475393 BACKGROUND

• Bachasson 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.

  PMID: 27234310 BACKGROUND

MeSH Terms

Conditions

Myotonic Dystrophy; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hanife Hale Hekim, MD

  Antalya Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 25, 2026
• Study Start: June 20, 2025
• Primary Completion: October 15, 2025
• Study Completion: June 15, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

TU (1)