NCT05908279

Brief Summary

Previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in Parkinson disease (PD). On the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards maintaining a constant speed. Here the investigators want to better understand why it is altered in PD by measuring the transitions between gait instructed by a metronome, and gait without metronome. The experimental conditions will allow the comparisons between these transitions across PD and healthy groups of volunteers, and assess differences based on statistical and computational modelling. The link with potential freezing episodes will also be studied to assess whether the statistical determinants of gait control in this population can be used as a proxy or predictor of the occurence of freezing episodes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
May 2023Oct 2027

Study Start

First participant enrolled

May 1, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

4.5 years

First QC Date

May 25, 2023

Last Update Submit

June 8, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stride cadence

    Time between two consecutive heel strikes. Units are seconds.

    Measured during the entire experiment (an average of 4.5 years)

  • Stride amplitude

    Distance between two consecutive heel strikes. Units are meters.

    Measured during the entire experiment (an average of 4.5 years)

Study Arms (2)

PD

Patients with Parkinson's disease

Other: Walking testOther: Disease assessement

Control

Healthy volunteers

Other: Walking test

Interventions

Walk with and without a metronome

ControlPD

Disease stage assessed by a doctor

PD

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One group of volunteers with previous diagnosis of Parkinson disease and one group of age and sex matched healthy volunteers.

You may qualify if:

  • Patients and volunteers able to walk for 20mins and without other neurological disorders.

You may not qualify if:

  • Patients or volunteers unable to walk for 20mins and with other neurological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université catholique de Louvain

Louvain-la-Neuve, 1348, Belgium

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Frederic Crevecoeur

    Université Catholique de Louvain

    STUDY DIRECTOR

Central Study Contacts

Frederic Crevecoeur

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 18, 2023

Study Start

May 1, 2023

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations