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

Rigshospitalet

Status: Completed

Conditions: Myasthenia Gravis

Treatments: Other: 6-minute walk test

Study type: Observational

Funder types: Other

Identifiers

NCT03905161

H-18031231 3

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 1 patient group

Myasthenia patients

Description:

Danish patients with myasthenia gravis seen at the Department of Neurology, Rigshospitalet

Treatment:

Other: 6-minute walk test