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Completed

NCT Number: NCT04653688

Markers of Disease Progression and Gait Within the Parkinsonian Population

The aim of the project is to evaluate disease progression of patients with Parkinsonian syndrome of various severity through regular home-based gait parameters analysis.

We identified several steps in this project:

1. Acquisition of gait data in 120 patients with Parkinsonism at different stages in hospital and ecological condition (during 10 days at home), in a repetitive manner:

1. 30 Early PD patients, before 3 years of disease duration (MDS criteria, 2018) 2. 30 PD patients with motor fluctuations (5 to 8 years of disease duration) (MDS criteria, 2018) 3. 30 PD patients with FoG (10 years of disease duration) (MDS criteria, 2018) 4. 30 patients with MSA (less than 5 years after the first symptom) 2. Control groups will be composed by 30 healthy volunteers Correlation analysis with clinical measurements and biomarkers, namely blood biomarkers for neurodegeneration (4HN, NFLT …) and multimodal MRI repeated assessments (Iron overload, inflammation and degeneration) and genetic panel for common haplotypes involved in Parkinsonism.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mobility Limitation Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

PD Patients:

  • Age: from 40 to 80 years
  • Absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking)

Each group will be composed of:

  • 30 PD with a disease duration < 3 years
  • 30 PD with a disease duration between 5 to 8 years
  • 30 PD with a disease duration > 10 years MSA Patients
  • Age > 30 years old
  • < 5 years of disease duration
  • deemed by the physicians to be able to walk at 1 year

Healthy subjects

  • Similar age and sex distribution

For all

  • Absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking)
  • Absence of cognitive disorders (MoCA> 24/30 according to the MDS criteria)
  • Stable treatment for at least 2 weeks before inclusion
  • Ability to walk at least 100 meters
  • Have an affiliation to the social security or equivalent
  • Have signed an informed consent

Exclusion criteria

  • STN DBS for PD patients
  • Intraduodeno-jejunal levodopa infusion (duodopa)
  • Inability to walk without aid (walker or walking stick)

Treatment and study plan

The FeetMe® Evaluation

Device

The FeetMe® Evaluation device is a medical device (class Im CE 0459) for ambulatory gait analysis, consisting of a pair of connected insoles and an Android mobile application.

the PKG® Watch,

Device

The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® system consists of a wrist-worn movement recording device known as the PKG® Watch,

MRI

Radiation
  • an anatomical 3D T1-weigthed gradient-echo sequence (1mm isotropic):
  • anatomical registration
  • automated segmentation
  • volumetric
  • texture analysis

DaTscan

Radiation
  • quantify nigrostriatal dopaminergic depletion
  • correlate its impact on the type and severity of gait disorders in Parkinson's disease.

Primary outcomes

  1. Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 48 weeks versus baseline in Parkinsonian syndrome patient subgroups and in a control group.

    Time frame: at 48 weeks

Secondary outcomes

  1. Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only) and 24 weeks versus baseline in Parkinsonian syndrome patient subgroups

    Time frame: at baseline at 12weeks, at 24 weeks and 48 weeks

  2. Changes of 95th percentile of home gait cadence, stride length, stride, stance and swing durations (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only), 24 and 48 weeks versus baseline

    Time frame: at baseline at 12weeks, at 24 weeks and 48 weeks

  3. Changes of UMSARS I-II versus baseline in MSA subgroup

    Time frame: at baseline at 12weeks, at 24 weeks and 48 weeks

    UMSARS contains four parts, the UMSARS-1 and UMSARS-2 are reported in this outcome. UMSARS-1 scores symptoms of neurological and autonomic dysfunction (12 questions). UMSARS-2 is motor examination (14 questions). All questions range from 0 (normal) to 4(extreme dysfunction). Higher scores mean greater the impairment. Negative change from baseline values indicate improvement.

  4. Changes of MSA-QoL versus baseline in MSA subgroup

    Time frame: at baseline at 24 and 48 weeks

    MSA-QoL is a patient-rated health-related Quality of life scale for patients with multiple system atrophy (MSA). Visual Analog score is designed to determine overall life satisfaction in patient with MSA. Scale is given response option format (0 - extremely unsatisfied with life 100 - extremely satisfied with life), where higher scores indicate better satisfaction/quality of life.

  5. Changes of OHQ versus baseline in MSA subgroup

    Time frame: at baseline at 24 and 48 weeks

    OHQ : Oxford Happiness Questionnaire. The total score ranges from 8 to 54, with a higher number indicating better subjective wellness

  6. Changes of OHSA versus baseline in MSA subgroup

    Time frame: at baseline at 24 and 48 weeks

    Orthostatic Hypotension Symptom Assessment (OHSA) and Orthostatic Hypotension Daily Activities Scale (OHDAS) 10 items measured on a Likert-scale

  7. Changes of BBS versus baseline in MSA subgroup

    Time frame: at baseline at 24 and 48 weeks

    Berg Balance Scale (BBS) is a clinical 14-item scale designed to measure balance

  8. Changes of Modified SE-ADL versus baseline in MSA subgroup

    Time frame: at baseline at 24 and 48 weeks

    The Schwab and England Activities of Daily Living (SE-ADL) evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100% indicates completely independent, 0% indicates bedridden with impaired vegetative functions), so that the lower the score, the worse the functional status. The assessment is conducted by a trained clinician.

  9. Changes of PDSS-2 versus baseline in MSA subgroup

    Time frame: at baseline at 24 and 48 weeks

    The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.

  10. Changes of COMPASS31 versus baseline in MSA subgroup

    Time frame: at baseline at 24 and 48 weeks

    Composite Autonomic Symptom Score (CONPASS 31) includes 31 questions and it will be used to assess autonomic symptoms that provides clinically relevant scores of autonomic symptom severity based. The higher the score the more autonomic symptoms present

  11. Changes of MOCA versus baseline in MSA subgroup

    Time frame: at baseline at 24 and 48 weeks

  12. MRI changes at 24 and 48 weeks versus baseline.

    Time frame: at baseline at 24 and 48 weeks

    For MSA subgroup and all subgroups

  13. DAT-scan changes at 48 weeks versus baseline.

    Time frame: at baseline at 48 weeks

    For Early PD subgroup

  14. PKG changes at 48 weeks versus baseline

    Time frame: at baseline and at 48 weeks

    in early PD and fluctuating subgroups.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • FeetMe
  • France Parkinson Association
  • H. Lundbeck A/S
  • Vaincre Parkinson

Registry information

Official study title

A Prospective Study on Markers of Disease Progression and Gait Within the Parkinsonian Population

Acronym: Gait'N'Park

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2020
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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