Polyneuropathy, Impairments & Physical Activity

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Amyloidosis
Charcot-Marie-Tooth
Charcot-Marie-Tooth Disease
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Diabetic Neuropathies
Diabetic Polyneuropathy
hATTR Amyloidosis
Hereditary Sensory and Motor Neuropathy
Multifocal Motor Neuropathy
Nerve Compression Syndromes
POEMS Syndrome
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Vasculitic Neuropathy

Clinical Trial Details

NCT number	NCT06040567
Study type	Observational
Source	Rigshospitalet, Denmark
Contact	Britt S Pedersen
Phone	+4535458401
Email	britt.staevnsbo.pedersen.01@regionh.dk
Status	Recruiting
Phase
Start date	September 23, 2023
Completion date	December 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02423434` - Evaluation of Corneal Confocal Microscopy for the Identification and Prediction of Neuropathy in Type 1 Diabetes
Completed	`NCT05542901` - Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees	N/A
Withdrawn	`NCT01536236` - Spinal Cord Stimulation for Diabetic Polyneuropathy	N/A
Active, not recruiting	`NCT01175928` - Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy	Phase 1/Phase 2
Completed	`NCT00993070` - Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy	Phase 2/Phase 3
Completed	`NCT00539175` - Treatment of Painful Diabetic Neuropathy With Photon Stimulation	N/A
Completed	`NCT00278980` - Effect of C-Peptide on Diabetic Peripheral Neuropathy	Phase 2
Completed	`NCT04593992` - HTEMS Treatment of Diabetic Polyneuropathy	N/A
Completed	`NCT01465620` - Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study	Phase 3
Completed	`NCT01079325` - Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy	Phase 2
Completed	`NCT00406458` - Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy	Phase 2
Recruiting	`NCT06072573` - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy	Phase 3
Recruiting	`NCT06071975` - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy	Phase 3
Recruiting	`NCT05521737` - Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy	N/A
Completed	`NCT01847937` - Magnetic Resonance Diagnostics of Diabetic Peripheral Neuropathy	N/A
Completed	`NCT00476931` - Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy	Phase 2
Completed	`NCT00977483` - Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2)	Phase 3
Completed	`NCT01006915` - Surgical Decompression for Diabetic Neuropathy in the Foot	N/A
Completed	`NCT00501202` - Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN).	Phase 2
Completed	`NCT00307749` - Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study — PolyImPAct

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms