About this trial
The project aims to investigate the validity, and reliability of outcome measures of muscle strength, functioning (gait, balance, and fine motor skills), physical activity, and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy. Further, the project aims to compare physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy with physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills) and daily living in healthy adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients will be recruited from a the neuromuscular clinic at Rigshopitalet, Copenjagen, Denmark
Trial design
Other
Prospective
Treatments tested in this trial
Validity and reliability of outcome measures in polyneuropathy
Other interventionPatients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years.
Healthy controls
Other interventionHealthy controls will be tested, answer patient reported outcome measures, and wear accelerometer at baseline visit. There is no follow-up in the healthy control group.
Treatment groups
Trial outcomes
Primary outcomes
10-meter Walk Test
The patient is asked to 10 meter as fast as possible
Six Spot Step Test
The patient is instructed to walk 5 meters as fast as possible, while kicking five cylinder blocks out of five circles marked on the floor.
6-minute Walk Test
The patient will be asked to walk back and forth along a 25 meter walkway for six minutes. They will be instructed to walk as far as possible for six minutes.
30 seconds Chair Stand Test
The patients will be asked to stand up and sit down as many times as possible in 30 secs with their arms across their chest
Secondary outcomes
Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS)
I-RODS is a 24-item patient reported outcome measure that measures disability. The raw score ranges from 0-48, with 0 indicating severe disability and higher scores indicating lower levels of disability.
Falls Efficacy Scale-International (FES-I)
Assesses limitations related to fear of falling. FES-I is a 16-item patient reported outcome measure that measures fear of falling. The score ranges from 16-64, with higher scores indicating greater fear of falling.
Composite Autonomic Symptom Score (COMPAS-31)
Assesses autonomic dysfunction Compass-31 is a patient reported outcome measure that measures autonomic dysfunction. Scores ranges from 0-100, with higher scores indicating more severe symptoms of autonomic dysfunction.
Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS)
Assesses neuropathic pain S-LANSS is a patient reported outcome measure for identifying neuropathic pain.
Sponsors and contacts
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