Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

NCT06040567 | Recruiting

• 1 other identifier: H-23032160
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Polyneuropathy; Clinical outcome measures; Patient reported outcome measures (PROMs); Physical activity; Accelerometer; Validity; Reliability; Responsiveness

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (9)

• 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

• Falls Efficacy Scale-International (FES-I)

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

• Composite Autonomic Symptom Score (COMPAS-31)

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

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

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

• Fatigue Severity Scale (FSS)

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

Study Arms (2)

Patients with polyneuropathy

Adults (\> 18 years) diagnosed with polyneuropathy

Other: Validity and reliability of outcome measures in polyneuropathy

Healthy controls

Healthy adults (\>18 years)

Other: Healthy controls

Interventions

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.

Patients with polyneuropathy

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.

Healthy controls

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from a the neuromuscular clinic at Rigshopitalet, Copenjagen, Denmark

You may qualify if:

• \> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)
• \> 18 years Healthy

You may not qualify if:

• Not verified polyneuropathy
• Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; POEMS Syndrome; Charcot-Marie-Tooth Disease; Diabetic Neuropathies; Polyneuropathies; Motor Activity

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunoproliferative Disorders; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Behavior

Study Officials

• Britt S Pedersen

  Rigshospitalet, University of Copenhagen

  STUDY CHAIR

Central Study Contacts

Britt S Pedersen

CONTACT

+4535458401; britt.staevnsbo.pedersen.01@regionh.dk

Tina Dysgaard

CONTACT

tina.dysgaard@regionh.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 15, 2023
• Study Start: September 23, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DK (1)