Walking and Thinking - Brain Activity During Complex Walking in Aging and Parkinson's Disease

NCT ID: NCT05218213

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-21

Study Completion Date

2023-06-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. However, the process of aging or the sequelae of neurological diseases such as Parkinson's disease (PD) compromises motor-cognitive interaction necessary for an independent lifestyle. While motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions.

The challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecological valid state. The investigators aim therefore to explore brain function during complex walking in healthy and PD by investigating the effects of age and neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fNIRS) and advanced gait analysis in real time in young, older healthy adults and people with PD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Gait Disorders, Neurologic Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy young

Healthy young adults

No intervention

Intervention Type OTHER

Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.

1. Dual-task walking with the auditory stroop task.
2. Navigational walking - a course consisting of a distribution of 45 and 90 degrees turns to the left and right
3. Navigational and dual-task walking (condition 1 and 2 together)

Healthy elderly

Healthy elderly adults

No intervention

Intervention Type OTHER

Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.

1. Dual-task walking with the auditory stroop task.
2. Navigational walking - a course consisting of a distribution of 45 and 90 degrees turns to the left and right
3. Navigational and dual-task walking (condition 1 and 2 together)

Parkinson's disease

Elderly with Parkinson's disease

No intervention

Intervention Type OTHER

Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.

1. Dual-task walking with the auditory stroop task.
2. Navigational walking - a course consisting of a distribution of 45 and 90 degrees turns to the left and right
3. Navigational and dual-task walking (condition 1 and 2 together)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.

1. Dual-task walking with the auditory stroop task.
2. Navigational walking - a course consisting of a distribution of 45 and 90 degrees turns to the left and right
3. Navigational and dual-task walking (condition 1 and 2 together)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-18 to 50 years


* ≥60 years of age,
* 23 or more on the Montreal Cognitive Assessment (MoCA)


* ≥60 years of age
* a clinical diagnosis of PD≤6 months prior to enrollment
* with the ability to walk without a mobility device for ≤5 minutes continuously.

Exclusion Criteria

* Disease or condition that affects cognition, gait or balance.
* Severe hearing or visual impairments that affects participation in the assessments

Healthy elderly:


* Disease or condition that affects gait or balance.
* Severe hearing or visual impairments that affects participation in the assessments

Parkinson cohort:


* People with speech difficulties (e.g. aphasia)
* cognitive difficulties affecting the ability to understand and/or follow verbal/written - instructions
* severe freezing of gait
* Severe hearing or visual impairments that affects participation in the assessments
* Other neurological diseases
* Other disease that can affect gait or balance.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Erika Franzén

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erika Franzén, PhD

Role: PRINCIPAL_INVESTIGATOR

Karollinska Institutet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karolinska institutet

Stockholm, Solna, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://osf.io/rhcb8

ParkMOVE OSF page

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-03059

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.