NCT06040567

Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 520 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2023-09-23
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-09-15
• Last updated: 2025-04-06

Locations

1 site across 1 country: Denmark