Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06040567

Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Abnormalities, Multiple Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Blood Protein Disorders Charcot-Marie-Tooth Charcot-Marie-Tooth Disease Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Demyelinating Diseases Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Polyneuropathy Disease Attributes Endocrine System Diseases Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Idiopathic Neuropathy Immune System Diseases Immunoproliferative Disorders Motor Activity Multifocal Motor Neuropathy Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases POEMS Syndrome Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Vasculitic Neuropathy hATTR Amyloidosis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Britt S Pedersen

CONTACT

[email protected]

+4535458401

Tina Dysgaard

CONTACT

+4535458077

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Validity and reliability of outcome measures in polyneuropathy

Other

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

Other

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.

Primary outcomes

  1. 10-meter Walk Test

    Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years

    The patient is asked to 10 meter as fast as possible

  2. Six Spot Step Test

    Time frame: 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.

  3. 6-minute Walk Test

    Time frame: 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.

  4. 30 seconds Chair Stand Test

    Time frame: 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

  5. Dynamic Gait Index

    Time frame: 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).

  6. Nine Hole Peg Test

    Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years

    Fine motor skills

  7. Jamar Hand-grip dynamometer (hand-grip-strength)

    Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years

    Best of three values

  8. Isometric strength measured with hand-held dynamometer

    Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years

    Will be tested bilateral at ankle, knee, wrist and elbow

  9. Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems

    Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years

    Will be tested bilateral at ankle and knee

  10. SENS motion activity sensor (accelerometer)

    Time frame: 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).

  11. Inflammatory Neuropathy Cause and Treatment (INCAT)

    Time frame: 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 outcomes

  1. Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS)

    Time frame: 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.

  2. Falls Efficacy Scale-International (FES-I)

    Time frame: 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.

  3. Composite Autonomic Symptom Score (COMPAS-31)

    Time frame: 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.

  4. Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS)

    Time frame: 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.

  5. Fatigue Severity Scale (FSS)

    Time frame: 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.

  6. PittsburghSleep Quality Index

    Time frame: 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

  7. Major Depression Inventory (MDI)

    Time frame: 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.

  8. International Physical Activity Questionaire (IPAQ)

    Time frame: 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.

  9. Physical Activity Scale (PAS2)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Britt S Pedersen

CONTACT

[email protected]

+4535458401

Tina Dysgaard

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: PolyImPAct

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.