An observational study in CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by Heinrich-Heine University, Duesseldorf. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Heinrich-Heine University, Duesseldorf · Observational
This prospective, longitudinal study aims to evaluate the usefulness of high-resolution whole-body motion data captured by wearable sensors to assess functional status and longitudinal changes in CIDP (chronic inflammatory demyelinating polyradiculoneuropathy) patients undergoing treatment. Close clinical monitoring will complement sensor-based movement data to investigate whether detailed kinematic measures can capture motor impairments and changes that are only partially reflected by established clinical scores.
CIDP is a rare chronic immune-mediated neurological condition that can lead to muscle weakness, sensory disturbances, gait impairment, and limitations in everyday activities. Due to the heterogeneous clinical presentation of CIDP, objective assessment of functional status and longitudinal changes remains challenging. Established clinical measures such as INCAT, I-RODS, MRC sum score, and grip strength provide important information on disability and motor function but may not capture subtle, regional, or multidimensional changes in movement.
Consequently, this study aims to evaluate high-resolution whole-body motion data to assess functional status and longitudinal changes in patients with CIDP. Firstly, sensor-based movement measures will be compared to established clinical scores, strength measurements, and patient-reported outcomes. Secondly, explorative analyses will aim to investigate whether longitudinal changes in movement patterns reflect changes in functional status and whether distinct movement phenotypes can be identified.
Data captured by the whole-body motion-sensing system (Xsens) includes three-dimensional kinematic parameters describing the movement of individual joints and body segments. These include joint angles, movement velocities, range of motion, acceleration, coordination, and side-to-side symmetry. Based on these parameters, multidimensional movement "fingerprints" will be derived to characterize individual motor function. Blood samples will additionally be collected for the analysis of potential biomarkers, including serum neurofilament light chain (sNfL), glial fibrillary acidic protein (GFAP), and proteomic data. The investigators aim to determine whether sensor-based movement patterns can capture regional and gradual motor impairments and whether they provide additional information beyond established clinical outcome measures.
Optionally, explorative analyses will investigate whether characteristic movement phenotypes, such as predominantly upper- or lower-limb, proximal or distal, or asymmetric impairment patterns, can be identified from the sensor data.
Patients will be recruited in Düsseldorf.
132 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 50 are open to participants now.
This study's planned enrollment of 50 is close to the median of 48 across 41 observational studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
CIDP patients treated at the University Hospital in Düsseldorf.
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Exclusion Criteria:
CIDP patients undergoing any treatment.
Device: Xsens motion suit
Non-interventional observational study with whole-body motion assessment to assess functional status and longitudinal changes in patients with CIDP.
Change in joint angle distributions during standardized movement tasks
Change in joint angle distributions across predefined joints and standardized movement tasks from baseline to 6 and 12 months. Joint angle distributions will be characterized using prespecified parameters describing joint kinematics. Changes in these parameters will be assessed at each follow-up visit relative to baseline.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in movement velocity
Quantitative assessment of joint and limb movement velocities during standardized motor tasks
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in movement-space volume
Quantification of the three-dimensional movement space achieved by individual joints or body segments during standardized movement tasks
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in coordination patterns
Quantitative assessment of intersegmental and inter-joint coordination during standardized movements
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in side-to-side movement symmetry
Quantification of asymmetries between the left and right sides during standardized upper- and lower-limb movements
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in proximal versus distal movement patterns
Quantification of differences in movement characteristics between proximal and distal joints and body segments
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in upper- versus lower-limb movement patterns
Quantification of differences in movement characteristics between upper and lower extremities
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in whole-body movement fingerprint
Longitudinal change in the multidimensional sensor-derived movement fingerprint
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived joint angle distributions and the I-RODS score
Correlation between sensor-derived joint angle distributions and activity and participation limitations assessed using the 24-item Inflammatory Rasch-built Overall Disability Scale (I-RODS). The I-RODS total score ranges from 0 to 48, with higher scores indicating better function.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived movement velocity and the I-RODS score
Correlation between sensor-derived movement velocity and activity and participation limitations assessed using the 24-item Inflammatory Rasch-built Overall Disability Scale (I-RODS). The I-RODS total score ranges from 0 to 48, with higher scores indicating better function.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived whole-body movement fingerprint and the I-RODS score
Correlation between sensor-derived whole-body movement fingerprint and activity and participation limitations assessed using the 24-item Inflammatory Rasch-built Overall Disability Scale (I-RODS). The I-RODS total score ranges from 0 to 48, with higher scores indicating better function.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived joint angle distributions and the INCAT disability score
Correlation between sensor-derived joint angle distributions and disability assessed using the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The INCAT total score ranges from 0 to 10, with lower scores indicating less disability and higher scores indicating greater disability.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived movement velocity and the INCAT disability score
Correlation between sensor-derived movement velocity and disability assessed using the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The INCAT total score ranges from 0 to 10, with lower scores indicating less disability and higher scores indicating greater disability.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived whole-body movement fingerprint and the INCAT disability score
Correlation between sensor-derived whole-body movement fingerprint and disability assessed using the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The INCAT total score ranges from 0 to 10, with lower scores indicating less disability and higher scores indicating greater disability.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived joint angle distributions and the MRC sum score
Correlation between sensor-derived joint angle distributions and muscle strength assessed using the Medical Research Council (MRC) sum score. The MRC sum score ranges from 0 to 60, with higher scores indicating greater muscle strength.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived movement velocity and the MRC sum score
Correlation between sensor-derived movement velocity and muscle strength assessed using the Medical Research Council (MRC) sum score. The MRC sum score ranges from 0 to 60, with higher scores indicating greater muscle strength.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived whole-body movement fingerprint and the MRC sum score
Correlation between sensor-derived whole-body movement fingerprint and muscle strength assessed using the Medical Research Council (MRC) sum score. The MRC sum score ranges from 0 to 60, with higher scores indicating greater muscle strength.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived joint angle distributions and handgrip strength
Correlation between sensor-derived joint angle distributions and handgrip strength assessed using a Martin Vigorimeter. Handgrip strength is expressed in kilopascals (kPa), according to the standardized measurement protocol.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived movement velocity and handgrip strength
Correlation between sensor-derived movement velocity and handgrip strength assessed using a Martin Vigorimeter. Handgrip strength is expressed in kilopascals (kPa), according to the standardized measurement protocol.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Correlation between sensor-derived whole-body movement fingerprint and handgrip strength
Correlation between sensor-derived whole-body movement fingerprint and handgrip strength assessed using a Martin Vigorimeter. Handgrip strength is expressed in kilopascals (kPa), according to the standardized measurement protocol.
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in Pittsburgh Sleep Quality Index (PSQI)
Patient-reported assessment of subjective sleep quality
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in Fatigue Severity Scale (FSS)
Patient-reported assessment of the severity and impact of fatigue
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in WHOQOL-BREF
Patient-reported assessment of health-related quality of life across multiple domains
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Change in blood-based biomarkers
Blood-based analyses including serum neurofilament light chain (sNfL), glial fibrillary acidic protein (GFAP), and proteomic analyses
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Longitudinal change in standardized walking performance
Sensor-based assessment of movement characteristics during standardized walking tasks, including gait-related kinematic parameters
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Longitudinal change in Timed Up and Go performance
Sensor-based assessment of whole-body kinematics during the Timed Up and Go task, including sit-to-stand, walking, turning, and stand-to-sit components
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Longitudinal change in sit-to-stand performance
Sensor-based assessment of whole-body movement during standardized sit-to-stand and transfer tasks
Time frame: Baseline (V1), Month 6 (V2), Month 12 (V3)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2028, 15 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →
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