Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

Rigshospitalet

Status: Enrolling

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

Treatments: Other: Validity and reliability of outcome measures in polyneuropathy; Other: Healthy controls

Study type: Observational

Funder types: Other

Identifiers

NCT06040567

H-23032160

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

520 participants in 2 patient groups

Patients with polyneuropathy

Description:

Adults (\> 18 years) diagnosed with polyneuropathy

Treatment:

Other: Validity and reliability of outcome measures in polyneuropathy

Healthy controls

Description:

Healthy adults (\>18 years)

Treatment:

Other: Healthy controls