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NCT Number: NCT07493525

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Fear of falling

    Time frame: At baseline

    Fear of falling will be assessed using semi-structured questions regarding the fear of falling experienced by patients with myotonic dystrophy type 1.

  2. Muscular Impairment Rating Scale score

    Time frame: At baseline

    Disease-related muscle involvement severity will be assessed using the Muscular Impairment Rating Scale (MIRS).

  3. Dynamic balance performance by Timed Up and Go test

    Time frame: At baseline

    Dynamic balance performance will be assessed using the Timed Up and Go (TUG) test.

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

    Time frame: At baseline

    Walking performance and dynamic mobility will be assessed using the 10-Meter Walk Test at maximum safe speed.

  5. Isometric muscle strength

    Time frame: At baseline

    Isometric muscle strength of selected muscle groups will be measured to evaluate the relationship between muscle strength and fall frequency.

  6. Hand grip strength

    Time frame: At baseline

    Hand grip strength will be measured using a hand grip strength assessment.

  7. Balance performance by Berg Balance Scale

    Time frame: At baseline

    Balance performance will be evaluated using the Berg Balance Scale.

  8. Functional Ambulation Scale score

    Time frame: At baseline

    Ambulation level will be recorded using the Functional Ambulation Scale (FAS).

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Determination of Fall Frequency and Factors Affecting Dynamic Balance in Patients With Myotonic Dystrophy Type 1: A Cross-Sectional Observational Single-Center Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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