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.
In four phases the investigators will evaluate physical activity and the validity, reliability, and responsiveness of the outcome measures in patients with polyneuropathy. During the four phases clinical outcome measures, patient-reported outcomes measures, and accelerometer data on physical activity will be evaluated. The investigators plan to include 400 adult patients with polyneuropathy (acquired, hereditary, and idiopathic) from our clinic and 120 adult healthy controls. The 400 patients with polyneuropathy include the following subtypes of polyneuropathy: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), vasculitis polyneuropathy, Polyneuropathy-Organomegaly-Endocrinopathy-Monoclonal protein-Skin changes (POEMS syndrome), Multifocal Motor Neuropathy (MMN), Charcot Marie Tooth (CMT), hATTR amyloidosis, Diabetic Polyneuropathy (DPN), and idiopathic neuropathy.
Study Type
OBSERVATIONAL
Enrollment
520
Patients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years.
Healthy 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.
Copenhagen Neuromuscular Center, Rigshospitalet
Copenhagen, Denmark
RECRUITING10-meter Walk Test
The patient is asked to 10 meter as fast as possible
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Dynamic Gait Index
The patient will be asked to walk while performing different tasks (walking: normally, while changing speed, while turning head (vertical and horizontal), while turning around, while stepping over obstacles, and walking stairs).
Time frame: At baseline, after 2-4 weeks, and after 1-2 years
Nine Hole Peg Test
Fine motor skills
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Jamar Hand-grip dynamometer (hand-grip-strength)
Best of three values
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Isometric strength measured with hand-held dynamometer
Will be tested bilateral at ankle, knee, wrist and elbow
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems
Will be tested bilateral at ankle and knee
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
SENS motion activity sensor (accelerometer)
The SENS motion activity sensor is a wearable accelerometer. It measures physical activity by collecting raw data of accelerations. Data on active time, sedentary time, time spent walking and number of steps taken will be collected. The sensor will be attached and worn 24/7 (the sensor will be worn the week following baseline tests, and the week after tests at visit three (1-2 years after baseline).
Time frame: At baseline (study entry), and after 1-2 years
Inflammatory Neuropathy Cause and Treatment (INCAT)
Interview based disability scale INCAT evaluates disability of the upper and lower limb. The total INCAT score ranges from 0-10 (low scores indicating no disability and higher scores indicating higher level of disability).
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Fatigue Severity Scale (FSS)
Assesses fatigue FSS is a 9-item patient reported outcome measure that measures fatigue, and the impact of fatigue on physical activity and daily living. The score ranges from 9-63, with a higher score indicating higher levels of fatigue.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
PittsburghSleep Quality Index
PittsburghSleep Quality Index is a patient reported outcome measure that assesses sleep quality. The score ranges from 0-21, with higher scores indicating more affected sleep quality
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Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Major Depression Inventory (MDI)
MDI is a patient reported outcome measure that measures depressive symptoms. The score ranges from 0-50, with higher scores indicating deeper depression.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
International Physical Activity Questionaire (IPAQ)
International Physical Activity Questionaire (IPAQ) is a patient reported outcome measure that measures physical activity.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Physical Activity Scale (PAS2)
PAS2 is a 7-item patient reported outcome measure that measures physical activity and sedentary behavior.
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years