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Myotonia and Muscle Stiffness in NMD

L

LMU Klinikum

Status

Completed

Conditions

Neuromuscular Disorders

Treatments

Diagnostic Test: Six-minute walk test
Diagnostic Test: Hand-held Dynamometry of muscle strength
Device: MyotonPro
Diagnostic Test: Semiquantitative muscle ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT04411732
Version: 1 [01-JUL-2019]

Details and patient eligibility

About

The primary objective of this study is to assess stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with dystrophic or non-dystrophic myotonia. The secondary objectives are (1) to provide reference values for stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with dystrophic or non-dystrophic myotonia; to provide reference values for stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with non-myotonic neuromuscular disorders, (3) assess correlations between to compare result values for stiffness, muscle tone, relaxation periods and elasticity with clinical muscle function tests, measured by clinical evaluation (MRC-scale) and the 6-minute walk test; (4) assess correlations between subcutaneous fat and muscle thickness and echogenicity, measured by muscle ultrasound and result values for stiffness, muscle tone, relaxation periods and elasticity.

Enrollment

133 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

For Patients:

  • ≥18 years of age
  • Confirmed neuromuscular disease
  • written consent
  • able and willing to perform study prodcedures

For healthy volunteers:

  • age ≥18 years of age
  • written informed consent
  • no clinical sign for neuromuscular disorders

Exclusion criteria

  • Severe comorbidities
  • Patient is participating in another clinical study using investigational treatment
  • Patient cannot perform required muscle function tests
  • the patient, in the opinion of the investigator, is unable to adhere to the requirements of the study

Trial design

133 participants in 2 patient groups

patients with neuromuscular disorder
Description:
cohort of patients with neuromuscular disorder
Treatment:
Diagnostic Test: Six-minute walk test
Device: MyotonPro
Diagnostic Test: Semiquantitative muscle ultrasound
Diagnostic Test: Hand-held Dynamometry of muscle strength
healthy controls
Description:
cohort of healthy controls
Treatment:
Diagnostic Test: Six-minute walk test
Device: MyotonPro
Diagnostic Test: Semiquantitative muscle ultrasound
Diagnostic Test: Hand-held Dynamometry of muscle strength

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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