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

March 20, 2026 updated by: Ceren Arslan, Antalya Training and Research Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Antalya
      • Antalya, Antalya, Turkey (Türkiye), 07100
        • Antalya Training And Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline
Muscular Impairment Rating Scale score
Time Frame: At baseline
Disease-related muscle involvement severity will be assessed using the Muscular Impairment Rating Scale (MIRS).
At baseline
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.
At baseline
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.
At baseline
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.
At baseline
Hand grip strength
Time Frame: At baseline
Hand grip strength will be measured using a hand grip strength assessment.
At baseline
Balance performance by Berg Balance Scale
Time Frame: At baseline
Balance performance will be evaluated using the Berg Balance Scale.
At baseline
Functional Ambulation Scale score
Time Frame: At baseline
Ambulation level will be recorded using the Functional Ambulation Scale (FAS).
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Study Chair: Hanife Hale Hekim, MD, Antalya Training And Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2025

Primary Completion (Actual)

October 15, 2025

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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