## Protocol Section
### Identification Module
**NCT ID:** NCT05908279

**Acronym:** GAIT-PD

**Brief Title:** Gait Control in Parkinson Disease

**Official Title:** Flexible Control of Gait in Parkinson Disease: Effect of Task Instruction on the Exploitation of Redundancy in Speed Control.

#### Organization Study ID Info
**ID:** GAIT-PD
#### Organization
**Class:** OTHER
**Full Name:** Université Catholique de Louvain
### Status Module
#### Completion Date
**Date:** 2027-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-01

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2023-06-18
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-25
**Study First Submit QC Date:** 2023-06-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Université Catholique de Louvain

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Parkinson Disease

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with Parkinson's disease

**Intervention Names:**

- Other: Walking test

- Other: Disease assessement

**Label:** PD

#### Arm Group 2

**Description:** Healthy volunteers

**Intervention Names:**

- Other: Walking test

**Label:** Control

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control

- PD

**Description:** Walk with and without a metronome

**Name:** Walking test

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- PD

**Description:** Disease stage assessed by a doctor

**Name:** Disease assessement

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Time between two consecutive heel strikes. Units are seconds.

**Measure:** Stride cadence

**Time Frame:** Measured during the entire experiment (an average of 4.5 years)

**Description:** Distance between two consecutive heel strikes. Units are meters.

**Measure:** Stride amplitude

**Time Frame:** Measured during the entire experiment (an average of 4.5 years)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

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

**Healthy Volunteers:** True

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** andre.mouraux@uclouvain.be

**Name:** André Mouraux, PhD

**Phone:** +32 2 764 54 47

**Role:** CONTACT

**Contact 2:**

**Email:** frederic.crevecoeur@uclouvain.be

**Name:** Frederic Crevecoeur

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Louvain-la-Neuve

**Contacts:**

***Contact 1:***

- **Email:** andre.mouraux@uclouvain.be

- **Name:** Andre Mouraux, PhD

- **Phone:** +32 2 764 54 47

- **Role:** CONTACT

**Country:** Belgium

**Facility:** Université catholique de Louvain

**Status:** RECRUITING

**Zip:** 1348

#### Overall Officials

**Official 1:**

**Affiliation:** Université Catholique de Louvain

**Name:** Frederic Crevecoeur

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Misc Info Module

- Version Holder: 2024-05-24
