Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

Conditions
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Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy, POEMS Syndrome, Multifocal Motor Neuropathy, Charcot-Marie-Tooth, hATTR Amyloidosis, Diabetic Polyneuropathy, Idiopathic Neuropathy, Polyneuropathies

Intervention / Treatment
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* Other: Validity and reliability of outcome measures in polyneuropathy
* Other: Healthy controls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria patients: > 18 years Diagnosed with polyneuropathy (verified by nerve conduction) Inclusion Criteria healthy controls: > 18 years Healthy Exclusion Criteria: Exclusion Criteria patients: Not verified polyneuropathy Exclusion Criteria healthy controls: Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with polyneuropathy<br>Adults (> 18 years) diagnosed with polyneuropathy | Other: Validity and reliability of outcome measures in polyneuropathy<br>* Patients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years.<br>|
| Healthy controls<br>Healthy adults (>18 years) | Other: Healthy controls<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-meter Walk Test | The patient is asked to 10 meter as fast as possible | 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. | 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. | 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 | 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). | At baseline, after 2-4 weeks, and after 1-2 years | 
| Nine Hole Peg Test | Fine motor skills | At baseline (study entry), after 2-4 weeks, and after 1-2 years | 
| Jamar Hand-grip dynamometer (hand-grip-strength) | Best of three values | 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 | 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 | 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). | 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). | At baseline (study entry), after 2-4 weeks, and after 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | At baseline (study entry), after 2-4 weeks, and after 1-2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyneuropathy, Clinical outcome measures, Patient reported outcome measures (PROMs), Physical activity, Accelerometer, Validity, Reliability, Responsiveness