Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06040567
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2023-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020277', 'term': 'Polyradiculoneuropathy, Chronic Inflammatory Demyelinating'}, {'id': 'D016878', 'term': 'POEMS Syndrome'}, {'id': 'D002607', 'term': 'Charcot-Marie-Tooth Disease'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D015417', 'term': 'Hereditary Sensory and Motor Neuropathy'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2023-09-01', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10-meter Walk Test', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'The patient is asked to 10 meter as fast as possible'}, {'measure': 'Six Spot Step Test', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'The patient is instructed to walk 5 meters as fast as possible, while kicking five cylinder blocks out of five circles marked on the floor.'}, {'measure': '6-minute Walk Test', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'The patient will be asked to walk back and forth along a 25 meter walkway for six minutes. They will be instructed to walk as far as possible for six minutes.'}, {'measure': '30 seconds Chair Stand Test', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'The patients will be asked to stand up and sit down as many times as possible in 30 secs with their arms across their chest'}, {'measure': 'Dynamic Gait Index', 'timeFrame': 'At baseline, after 2-4 weeks, and after 1-2 years', 'description': 'The patient will be asked to walk while performing different tasks (walking: normally, while changing speed, while turning head (vertical and horizontal), while turning around, while stepping over obstacles, and walking stairs).'}, {'measure': 'Nine Hole Peg Test', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'Fine motor skills'}, {'measure': 'Jamar Hand-grip dynamometer (hand-grip-strength)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'Best of three values'}, {'measure': 'Isometric strength measured with hand-held dynamometer', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'Will be tested bilateral at ankle, knee, wrist and elbow'}, {'measure': 'Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'Will be tested bilateral at ankle and knee'}, {'measure': 'SENS motion activity sensor (accelerometer)', 'timeFrame': 'At baseline (study entry), and after 1-2 years', 'description': 'The SENS motion activity sensor is a wearable accelerometer. It measures physical activity by collecting raw data of accelerations. Data on active time, sedentary time, time spent walking and number of steps taken will be collected.\n\nThe sensor will be attached and worn 24/7 (the sensor will be worn the week following baseline tests, and the week after tests at visit three (1-2 years after baseline).'}, {'measure': 'Inflammatory Neuropathy Cause and Treatment (INCAT)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'Interview based disability scale INCAT evaluates disability of the upper and lower limb. The total INCAT score ranges from 0-10 (low scores indicating no disability and higher scores indicating higher level of disability).'}], 'secondaryOutcomes': [{'measure': 'Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'I-RODS is a 24-item patient reported outcome measure that measures disability. The raw score ranges from 0-48, with 0 indicating severe disability and higher scores indicating lower levels of disability.'}, {'measure': 'Falls Efficacy Scale-International (FES-I)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'Assesses limitations related to fear of falling. FES-I is a 16-item patient reported outcome measure that measures fear of falling. The score ranges from 16-64, with higher scores indicating greater fear of falling.'}, {'measure': 'Composite Autonomic Symptom Score (COMPAS-31)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'Assesses autonomic dysfunction Compass-31 is a patient reported outcome measure that measures autonomic dysfunction. Scores ranges from 0-100, with higher scores indicating more severe symptoms of autonomic dysfunction.'}, {'measure': 'Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'Assesses neuropathic pain S-LANSS is a patient reported outcome measure for identifying neuropathic pain.'}, {'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'Assesses fatigue FSS is a 9-item patient reported outcome measure that measures fatigue, and the impact of fatigue on physical activity and daily living. The score ranges from 9-63, with a higher score indicating higher levels of fatigue.'}, {'measure': 'PittsburghSleep Quality Index', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'PittsburghSleep Quality Index is a patient reported outcome measure that assesses sleep quality. The score ranges from 0-21, with higher scores indicating more affected sleep quality'}, {'measure': 'Major Depression Inventory (MDI)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'MDI is a patient reported outcome measure that measures depressive symptoms. The score ranges from 0-50, with higher scores indicating deeper depression.'}, {'measure': 'International Physical Activity Questionaire (IPAQ)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'International Physical Activity Questionaire (IPAQ) is a patient reported outcome measure that measures physical activity.'}, {'measure': 'Physical Activity Scale (PAS2)', 'timeFrame': 'At baseline (study entry), after 2-4 weeks, and after 1-2 years', 'description': 'PAS2 is a 7-item patient reported outcome measure that measures physical activity and sedentary behavior.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polyneuropathy', 'Clinical outcome measures', 'Patient reported outcome measures (PROMs)', 'Physical activity', 'Accelerometer', 'Validity', 'Reliability', 'Responsiveness'], 'conditions': ['Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)', 'Vasculitic Neuropathy', 'POEMS Syndrome', 'Multifocal Motor Neuropathy', 'Charcot-Marie-Tooth', 'hATTR Amyloidosis', 'Diabetic Polyneuropathy', 'Idiopathic Neuropathy', 'Polyneuropathies']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from a the neuromuscular clinic at Rigshopitalet, Copenjagen, Denmark', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria patients:\n\n\\> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)\n\nInclusion Criteria healthy controls:\n\n\\> 18 years Healthy\n\nExclusion Criteria:\n\nExclusion Criteria patients:\n\nNot verified polyneuropathy\n\nExclusion Criteria healthy controls:\n\nDiabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy'}, 'identificationModule': {'nctId': 'NCT06040567', 'acronym': 'PolyImPAct', 'briefTitle': 'Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study', 'orgStudyIdInfo': {'id': 'H-23032160'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with polyneuropathy', 'description': 'Adults (\\> 18 years) diagnosed with polyneuropathy', 'interventionNames': ['Other: Validity and reliability of outcome measures in polyneuropathy']}, {'label': 'Healthy controls', 'description': 'Healthy adults (\\>18 years)', 'interventionNames': ['Other: Healthy controls']}], 'interventions': [{'name': 'Validity and reliability of outcome measures in polyneuropathy', 'type': 'OTHER', 'description': 'Patients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years.', 'armGroupLabels': ['Patients with polyneuropathy']}, {'name': 'Healthy controls', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Britt S Pedersen', 'role': 'CONTACT', 'email': 'britt.staevnsbo.pedersen.01@regionh.dk', 'phone': '+4535458401'}, {'name': 'Tina Dysgaard', 'role': 'CONTACT', 'phone': '+4535458077'}], 'facility': 'Copenhagen Neuromuscular Center, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Britt S Pedersen', 'role': 'CONTACT', 'email': 'britt.staevnsbo.pedersen.01@regionh.dk', 'phone': '+4535458401'}, {'name': 'Tina Dysgaard', 'role': 'CONTACT', 'email': 'tina.dysgaard@regionh.dk'}], 'overallOfficials': [{'name': 'Britt S Pedersen', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Britt Stævnsbo Pedersen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}