Rhythmic Auditory Stimulation and Walking Speed in the 6-minute Walk Test

Completed

• Conditions: Myasthenia Gravis
• Interventions: Other: 6-minute walk test

• Registration Number: NCT03905161
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2019-02-10
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-05
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Myasthenia patients	6-minute walk test	Danish patients with myasthenia gravis seen at the Department of Neurology, Rigshospitalet

Primary Outcome Measures

Name	Time	Method
6-minute walk test (6MWT)	6 minutes	The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test.

Secondary Outcome Measures

Name	Time	Method
Myasthenia gravis composite score (MGC)	30 minutes	The Myasthenia Gravis composite score (MGC) covers 10 important functional domains most frequently involved in patients with MG. This scoring system is based on quantitative testing of muscle groups, or symptom history told by the patient, by means of a 4 point scale ranging from 0 (no symptoms) to 9 (severe symptoms). The scale measures ocular, bulbar, respiratory and limb function, grading each finding, and the total score ranges from 0(no myasthenic findings) to 50 (maximal myasthenic deficits).
The Borg Rating of Perceived Exertion (RPE) scale.	2 minutes	Just after the completed 6MWT patients are asked to score the perceived exertion during walking. The scale is from 6 (no effort at all) to 20 (absolute maximal effort).
Heart rate	5 minutes	Monitoring of heart rate by a pulse-watch prior, during (average heart rate for 6 minutes) and after the 6MWT. All three measurements are in the same units (beats per minute), and are registered directly from the pulse-watch, which the patient wear during the walk test.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark