Clinical trial NCT05218213: Walking and Thinking - Brain Activity During Complex Walking in Aging and Parkinson's Disease
Official title: Walking and Thinking - Brain Activity During Complex Walking in Aging and Parkinson's Disease (Part of the ParkMOVE Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Aging
Keywords: functional near infrared spectrometry
gait
physical activity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2022-02-01
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are studying three different populations healthy young adults, healthy elderly and elderly with Parkinson's disease.

We have during 2021 conducted a pilot feasibility study including healthy young and elderly adults to refine the experimental protocol. Some of these subjects may be included in the full trial when the experimental protocol is shown to be feasible

Brief summary: 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.


Eligibility criteria: Healthy young:

Inclusion criteria:

-18 to 50 years

Exclusion criteria:

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

Healthy elderly:

Inclusion criteria:

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

Exclusion criteria:

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

Parkinson cohort:

Inclusion criteria:

* ≥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:

* 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.

Primary outcomes:
measure: Functional near infrared spectrometry (fNIRS)
timeFrame: During the test session during all three conditions
measure: Gait performance during all conditions
timeFrame: During the test session during all three conditions
measure: Dual-task performance-reaction time
timeFrame: During the test session during dual task conditions
Secondary outcomes:
measure: Cognitive function- composite score
timeFrame: During the test session, takes about 50 minutes
measure: Cognitive function - verbal fluency
timeFrame: During the test session, takes about 12 minutes
measure: Cognitive function - Attention and psychomotor processing speed
timeFrame: During the test session, takes about 3 minutes
measure: Cognitive function - Episodic memory
timeFrame: During the test session, takes about 30 minutes
measure: Cognitive function - Inhibition & task-set switching
timeFrame: During the test session, takes about 5 minutes
measure: Self-reported level of physical activity
timeFrame: Through study completion, an average of 1 year
measure: Physical activity level and intensity
timeFrame: For one week after the test session
measure: Motor function/disease severity
timeFrame: During the test session
measure: Balance performance
timeFrame: During the test session
measure: Anxiety and depression
timeFrame: Will be answered before the test session in the patients home or during the test session
measure: Walking ability
timeFrame: Will be answered before the test session in the patients home or at the test session
measure: Dual-task performance -errors
timeFrame: During the test session during dual task conditions
measure: Disability
timeFrame: Will be answered before the test session in the patients home or during the test session
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet
state: Solna
Study officials:
affiliation: Karollinska Institutet
name: Erika Franzén, PhD
role: PRINCIPAL_INVESTIGATOR
References: