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Clinical Trials/NCT03905161
NCT03905161
Completed
N/A

Does Rhythmic Auditory Stimulation Influence Walking Speed in the 6-minute Walk Test in Patients With Myasthenia Gravis?

Rigshospitalet, Denmark1 site in 1 country48 target enrollmentFebruary 10, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myasthenia Gravis
Sponsor
Rigshospitalet, Denmark
Enrollment
48
Locations
1
Primary Endpoint
6-minute walk test (6MWT)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this study is to investigate if rhythmic auditory stimulation can influence walking speed, during a 6MWT in patients with myasthenia gravis (MG).

Detailed Description

Background 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.

Registry
clinicaltrials.gov
Start Date
February 10, 2019
End Date
January 10, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Linda Kahr Andersen

Research Physiotherapist, PhD student

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Able to provide signed informed consent.
  • 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

  • MGFA grade V disease
  • 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

Outcomes

Primary Outcomes

6-minute walk test (6MWT)

Time Frame: 6 minutes

The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test.

Secondary Outcomes

  • Myasthenia gravis composite score (MGC)(30 minutes)
  • The Borg Rating of Perceived Exertion (RPE) scale.(2 minutes)
  • Heart rate(5 minutes)

Study Sites (1)

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