Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

NCT ID: NCT06040567

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-23

Study Completion Date

2026-12-31

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.

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with polyneuropathy

Adults (\> 18 years) diagnosed with polyneuropathy

Validity and reliability of outcome measures in polyneuropathy

Intervention Type 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

Healthy adults (\>18 years)

Healthy controls

Intervention Type 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.

Interventions

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Validity and reliability of outcome measures in polyneuropathy

Patients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years.

Intervention Type OTHER

Healthy controls

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


\> 18 years Healthy

Exclusion Criteria

Not verified polyneuropathy


Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Britt Stævnsbo Pedersen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Britt S Pedersen

Role: STUDY_CHAIR

Rigshospitalet, University of Copenhagen

Locations

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Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Britt S Pedersen

Role: CONTACT

+4535458401

Tina Dysgaard

Role: CONTACT

Facility Contacts

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Britt S Pedersen

Role: primary

+4535458401

Tina Dysgaard

Role: backup

+4535458077

Other Identifiers

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H-23032160

Identifier Type: -

Identifier Source: org_study_id

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