Rhythmic Auditory Stimulation and Walking Speed in the 6-minute Walk Test
NCT ID: NCT03905161
Last Updated: 2020-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2019-02-10
2020-01-10
Brief Summary
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Detailed Description
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1. The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy and disease progression in patients with neuromuscular diseases and is found valid and reliable to measure decrease in walking speed.
2. Rhythmic auditory stimulation has repeatedly been shown to improve gait parameters in individuals with neurologic impairment.
The aim of this study is to investigate if rhythmic auditory stimulation can influence walking speed, during a 6MWT in patients with myasthenia gravis.
Patients with MG are asked to complete two 6MWTs separated by minimum 30 minutes of rest. Before the 6MWTs patient is instructed to walk 60 m as fast as possible, and their steps per minute (SPM) is recorded. When completing the 6MWTs, one of the tests is accompanied by music (m6MWT) with a beat per minute (BPM) corresponding to patients' SPM. The order of the 6MWTs is randomly decided by pre-ordered sealed envelopes.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Myasthenia patients
Danish patients with myasthenia gravis seen at the Department of Neurology, Rigshospitalet
6-minute walk test
The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy and disease progression in patients with neuromuscular diseases and is found valid and reliable to measure decrease in walking speed for neuromuscular patients.
Interventions
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6-minute walk test
The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy and disease progression in patients with neuromuscular diseases and is found valid and reliable to measure decrease in walking speed for neuromuscular patients.
Eligibility Criteria
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Inclusion Criteria
* Able to read and understand Danish or English.
* Diagnosis of mild to moderate MG (Able to provide signed informed consent.
* Able to read and understand Danish or English.
* Diagnosed with generalized mild to moderate myasthenia gravis (I-IV on the Myasthenia Gravis Foundation of American Clinical Classification, MGFA).
* Documented history of acetylcholine receptor (AChR) or Muscle Specific Kinase (MuSK) antibody positive, or abnormal repetitive nerve stimulation testing (decrement \> 10%) on electromyography (EMG) or abnormal single fiber EMG (conduction block or jitter) or based on their clinical history and symptom improvement with acetylcholinesterase inhibitors.
* Ability to walk \> 60 meters in a 6MWT.
Exclusion Criteria
* Other disorders that are not related to MG, or drugs, that interfere with muscle strength, walking ability, balance and fatigue (e.g. heart failure).
* Serious medical illness (e.g. uncontrolled insulin dependent diabetes mellitus, symptomatic coronary artery disease, and cancer).
* Dementia or pregnancy.
* Unspecified reasons judged by the investigator
18 Years
80 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Linda Kahr Andersen
Research Physiotherapist, PhD student
Principal Investigators
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Linda K Andersen
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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H-18031231 3
Identifier Type: -
Identifier Source: org_study_id
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