Actively Recruiting
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Led by Rigshospitalet, Denmark · Updated on 2025-04-06
520
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the accuracy and consistency of tests that measure muscle strength, movement abilities like walking and balance, daily physical activity, and patient-reported function in people with polyneuropathy. The study also compares these factors between patients with different types of polyneuropathy and healthy adults. Various subtypes of polyneuropathy being studied include chronic inflammatory demyelinating polyneuropathy, vasculitis polyneuropathy, POEMS syndrome, multifocal motor neuropathy, Charcot-Marie-Tooth disease, hATTR amyloidosis, diabetic polyneuropathy, and idiopathic neuropathy. The study involves four phases where clinical tests, patient questionnaires, and physical activity tracking with accelerometers are used to evaluate participants. About 400 adults diagnosed with polyneuropathy and 120 healthy adults will participate. Patients will be tested and complete outcome measures at the start, again after 2 to 4 weeks, and once more after 1 to 2 years. Healthy controls will be tested once at the baseline visit without follow-up. Participants in the patient group will undergo various walking, strength, and motor skill tests multiple times over the study period. They will also wear motion sensors to monitor physical activity and fill out questionnaires about symptoms, daily functioning, fatigue, sleep quality, and mood. The main outcomes include several walking and strength tests measured at baseline, after several weeks, and after up to two years. Safety and long-term effects will be monitored throughout the study duration, which lasts up to two years for patients.
CONDITIONS
Brief Title
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years diagnosed with polyneuropathy confirmed by nerve conduction testing
- Healthy adults over 18 years without polyneuropathy
You will not qualify if you...
- Patients without confirmed polyneuropathy
- Healthy controls with diabetes or brain, nerve, muscle, kidney, or liver disease
- Healthy controls diagnosed with polyneuropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline (study entry)
Participants undergo baseline testing, complete patient-reported outcome measures, and wear an accelerometer to evaluate physical activity and outcome measures.
1 baseline visit (in-person)
Duration - 2 to 4 weeks after baseline
Participants are reassessed after 2 to 4 weeks with repeat testing, patient-reported outcomes, and accelerometer data collection to evaluate reliability and responsiveness of outcome measures.
1 follow-up visit (in-person)
Duration - 1 to 2 years after baseline
Participants return after 1 to 2 years for final assessments including testing, patient-reported outcomes, and accelerometer data collection to evaluate long-term changes in physical activity and outcome measures.
1 long-term follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Copenhagen Neuromuscular Center, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
B
Britt S Pedersen
T
Tina Dysgaard
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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