Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
- Conditions
- hATTR AmyloidosisIdiopathic NeuropathyPOEMS SyndromeMultifocal Motor NeuropathyPolyneuropathiesVasculitic NeuropathyChronic Inflammatory Demyelinating Polyneuropathy (CIDP)Charcot-Marie-ToothDiabetic Polyneuropathy
- Interventions
- Other: Validity and reliability of outcome measures in polyneuropathyOther: Healthy controls
- Registration Number
- NCT06040567
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 520
Inclusion Criteria patients:
> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)
Inclusion Criteria healthy controls:
> 18 years Healthy
Exclusion Criteria patients:
Not verified polyneuropathy
Exclusion Criteria healthy controls:
Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with polyneuropathy Validity and reliability of outcome measures in polyneuropathy Adults (\> 18 years) diagnosed with polyneuropathy Healthy controls Healthy controls Healthy adults (\>18 years)
- Primary Outcome Measures
Name Time Method 10-meter Walk Test At baseline (study entry), after 2-4 weeks, and after 1-2 years The patient is asked to 10 meter as fast as possible
Six Spot Step Test At baseline (study entry), after 2-4 weeks, and after 1-2 years 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.
Dynamic Gait Index At baseline, after 2-4 weeks, and after 1-2 years 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).
Nine Hole Peg Test At baseline (study entry), after 2-4 weeks, and after 1-2 years Fine motor skills
Jamar Hand-grip dynamometer (hand-grip-strength) At baseline (study entry), after 2-4 weeks, and after 1-2 years Best of three values
Isometric strength measured with hand-held dynamometer At baseline (study entry), after 2-4 weeks, and after 1-2 years Will be tested bilateral at ankle, knee, wrist and elbow
Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems At baseline (study entry), after 2-4 weeks, and after 1-2 years Will be tested bilateral at ankle and knee
6-minute Walk Test At baseline (study entry), after 2-4 weeks, and after 1-2 years 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 At baseline (study entry), after 2-4 weeks, and after 1-2 years 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
SENS motion activity sensor (accelerometer) At baseline (study entry), and after 1-2 years 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).Inflammatory Neuropathy Cause and Treatment (INCAT) At baseline (study entry), after 2-4 weeks, and after 1-2 years 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).
- Secondary Outcome Measures
Name Time Method Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS) At baseline (study entry), after 2-4 weeks, and after 1-2 years 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.
Physical Activity Scale (PAS2) At baseline (study entry), after 2-4 weeks, and after 1-2 years PAS2 is a 7-item patient reported outcome measure that measures physical activity and sedentary behavior.
Falls Efficacy Scale-International (FES-I) At baseline (study entry), after 2-4 weeks, and after 1-2 years 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.
Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS) At baseline (study entry), after 2-4 weeks, and after 1-2 years Assesses neuropathic pain S-LANSS is a patient reported outcome measure for identifying neuropathic pain.
Fatigue Severity Scale (FSS) At baseline (study entry), after 2-4 weeks, and after 1-2 years 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.
PittsburghSleep Quality Index At baseline (study entry), after 2-4 weeks, and after 1-2 years 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
International Physical Activity Questionaire (IPAQ) At baseline (study entry), after 2-4 weeks, and after 1-2 years International Physical Activity Questionaire (IPAQ) is a patient reported outcome measure that measures physical activity.
Composite Autonomic Symptom Score (COMPAS-31) At baseline (study entry), after 2-4 weeks, and after 1-2 years 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.
Major Depression Inventory (MDI) At baseline (study entry), after 2-4 weeks, and after 1-2 years MDI is a patient reported outcome measure that measures depressive symptoms. The score ranges from 0-50, with higher scores indicating deeper depression.
Trial Locations
- Locations (1)
Copenhagen Neuromuscular Center, Rigshospitalet
🇩🇰Copenhagen, Denmark