Walking and Thinking - Brain Activity During Complex Walking in Aging and Parkinson's Disease
ParkMOVE
1 other identifier
observational
133
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2022
1 active site
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
First Submitted
Initial submission to the registry
December 21, 2021
CompletedStudy Start
First participant enrolled
January 21, 2022
CompletedFirst Posted
Study publicly available on registry
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2023
CompletedOctober 24, 2024
October 1, 2024
1.4 years
December 21, 2021
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Functional near infrared spectrometry (fNIRS)
The measurement of changes in concentration of HbO and HHb in the prefrontal cortex will be assessed using a NIRSPORT 2 (NIRx Medizintechnik, Berlin, Germany) device
During the test session during all three conditions
Gait performance during all conditions
Gait variables such as stride time and/or velocity will be analyzed with the APDM mobility system.
During the test session during all three conditions
Dual-task performance-reaction time
Cognitive performance of the dual task will be assessed as errors in the response to the Auditory stroop task.
During the test session during dual task conditions
Secondary Outcomes (13)
Cognitive function- composite score
During the test session, takes about 50 minutes
Cognitive function - verbal fluency
During the test session, takes about 12 minutes
Cognitive function - Attention and psychomotor processing speed
During the test session, takes about 3 minutes
Cognitive function - Episodic memory
During the test session, takes about 30 minutes
Cognitive function - Inhibition & task-set switching
During the test session, takes about 5 minutes
- +8 more secondary outcomes
Study Arms (3)
Healthy young
Healthy young adults
Healthy elderly
Healthy elderly adults
Parkinson's disease
Elderly with Parkinson's disease
Interventions
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)
Eligibility Criteria
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
You may qualify if:
- to 50 years
You may not qualify if:
- Disease or condition that affects cognition, gait or balance.
- Severe hearing or visual impairments that affects participation in the assessments
- Healthy elderly:
- ≥60 years of age,
- or more on the Montreal Cognitive Assessment (MoCA)
- Disease or condition that affects gait or balance.
- Severe hearing or visual impairments that affects participation in the assessments
- Parkinson cohort:
- ≥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.
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Karolinska University Hospitalcollaborator
Study Sites (1)
Karolinska institutet
Stockholm, Solna, 17177, Sweden
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erika Franzén, PhD
Karollinska Institutet
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 21, 2021
First Posted
February 1, 2022
Study Start
January 21, 2022
Primary Completion
June 20, 2023
Study Completion
June 28, 2023
Last Updated
October 24, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ANALYTIC CODE
- Time Frame
- We plan to share this when applicable on OSF or similar
- Access Criteria
- The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request. Any sharing of data will be regulated via a data transfer and user agreement with the recipient.
The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request. Any sharing of data will be regulated via a data transfer and user agreement with the recipient.