Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)PolyImPActNCT06040567
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
An observational study of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Vasculitic Neuropathy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy, POEMS Syndrome
- What is being tested?
- Validity and reliability of outcome measures in polyneuropathy
- How many people
- 520 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from a the neuromuscular clinic at Rigshopitalet, Copenjagen, Denmark
Who may be able to join
- > 18 years Diagnosed with polyneuropathy (verified by nerve conduction)
- > 18 years Healthy
Who cannot join
- Not verified polyneuropathy
- Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Neuromuscular Center, Rigshospitalet
Copenhagen, 2100
About this study
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.
Read the 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
- Being tested
- Validity and reliability of outcome measures in polyneuropathy, Healthy controls
- Keywords
- Polyneuropathy, Clinical outcome measures, Patient reported outcome measures (PROMs), Physical activity, Accelerometer, Validity, Reliability, Responsiveness
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, POEMS Syndrome, Charcot-Marie-Tooth Disease, Diabetic Neuropathies, Polyneuropathies, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validity and reliability of outcome measures in polyneuropathyOther
Patients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years.
Healthy controlsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with polyneuropathy | Adults (> 18 years) diagnosed with polyneuropathy Receives: Other: Validity and reliability of outcome measures in polyneuropathy | |
| Healthy controls | Healthy adults (>18 years) Receives: Other: Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-meter Walk Test
The patient is asked to 10 meter as fast as possible
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Six Spot Step Test
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.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
6-minute Walk Test
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.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
30 seconds Chair Stand Test
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
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Dynamic Gait Index
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).
Measured: At baseline, after 2-4 weeks, and after 1-2 years
Nine Hole Peg Test
Fine motor skills
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Jamar Hand-grip dynamometer (hand-grip-strength)
Best of three values
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Isometric strength measured with hand-held dynamometer
Will be tested bilateral at ankle, knee, wrist and elbow
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems
Will be tested bilateral at ankle and knee
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
SENS motion activity sensor (accelerometer)
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.
The 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).
Measured: At baseline (study entry), and after 1-2 years
Inflammatory Neuropathy Cause and Treatment (INCAT)
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).
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Secondary outcomes (9)
Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS)
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.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Falls Efficacy Scale-International (FES-I)
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.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Composite Autonomic Symptom Score (COMPAS-31)
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.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS)
Assesses neuropathic pain S-LANSS is a patient reported outcome measure for identifying neuropathic pain.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Fatigue Severity Scale (FSS)
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.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
PittsburghSleep Quality Index
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
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Major Depression Inventory (MDI)
MDI is a patient reported outcome measure that measures depressive symptoms. The score ranges from 0-50, with higher scores indicating deeper depression.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
International Physical Activity Questionaire (IPAQ)
International Physical Activity Questionaire (IPAQ) is a patient reported outcome measure that measures physical activity.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Physical Activity Scale (PAS2)
PAS2 is a 7-item patient reported outcome measure that measures physical activity and sedentary behavior.
Measured: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start23 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britt Stævnsbo Pedersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Britt S Pedersen, Study chair, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040567
- Sponsor's protocol ID
- H-23032160
- Acronym
- PolyImPAct
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
- ClinicalTrials.gov ID
- NCT06040567
- Acronym / sponsor ID
- PolyImPAct / H-23032160
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy, POEMS Syndrome, Multifocal Motor Neuropathy, Charcot-Marie-Tooth, hATTR Amyloidosis
- Keywords
- Polyneuropathy, Clinical outcome measures, Patient reported outcome measures (PROMs), Physical activity, Accelerometer, Validity, Reliability, Responsiveness
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with polyneuropathy | – | Other: Validity and reliability of outcome measures in polyneuropathyAdults (> 18 years) diagnosed with polyneuropathy |
| Healthy controls | – | Other: Healthy controlsHealthy adults (>18 years) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from a the neuromuscular clinic at Rigshopitalet, Copenjagen, Denmark
Key inclusion criteria (2 listed)
- > 18 years Diagnosed with polyneuropathy (verified by nerve conduction)
- > 18 years Healthy
Key exclusion criteria (2 listed)
- Not verified polyneuropathy
- Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validity and reliability of outcome measures in polyneuropathyPatients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years. | Other | Patients with polyneuropathy |
| Healthy controlsHealthy 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. | Other | Healthy controls |
Primary outcome
10-meter Walk Test
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
The patient is asked to 10 meter as fast as possible
Six Spot Step Test
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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.
6-minute Walk Test
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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.
30 seconds Chair Stand Test
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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
Dynamic Gait Index
Time frame: At baseline, after 2-4 weeks, and after 1-2 years
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).
Nine Hole Peg Test
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Fine motor skills
Jamar Hand-grip dynamometer (hand-grip-strength)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Best of three values
Isometric strength measured with hand-held dynamometer
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Will be tested bilateral at ankle, knee, wrist and elbow
Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Will be tested bilateral at ankle and knee
SENS motion activity sensor (accelerometer)
Time frame: At baseline (study entry), and after 1-2 years
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. The 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).
Inflammatory Neuropathy Cause and Treatment (INCAT)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
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).
9 secondary outcomes
Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Falls Efficacy Scale-International (FES-I)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Composite Autonomic Symptom Score (COMPAS-31)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Fatigue Severity Scale (FSS)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
PittsburghSleep Quality Index
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Major Depression Inventory (MDI)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
International Physical Activity Questionaire (IPAQ)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Physical Activity Scale (PAS2)
Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt S Pedersen study chair
Rigshospitalet, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Vasculitic Neuropathy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-meter Walk Test (time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.