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

Walking and Thinking - Brain Activity During Complex Walking in Aging and Parkinson's Disease (Part of the ParkMOVE Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Aging; Gait Disorders, Neurologic
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Compliance Office -KI; Phone Number: +46852480000; Email: compliance@ki.se

Study Locations

• Sweden
  • Solna
    • Stockholm, Solna, Sweden, 17177
      • Recruiting
      • Karolinska Institutet
      • Contact: Erika Franzén, PhD; Phone Number: +46852488878; Email: erika.franzen@ki.se
      • Principal Investigator: Erika Franzén, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy young; Healthy young adults	Other: No intervention; Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.; Dual-task walking with the auditory stroop task.; Navigational walking - a course consisting of a distribution of 45 and 90 degrees turns to the left and right; Navigational and dual-task walking (condition 1 and 2 together)
Healthy elderly; Healthy elderly adults	Other: No intervention; Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.; Dual-task walking with the auditory stroop task.; Navigational walking - a course consisting of a distribution of 45 and 90 degrees turns to the left and right; Navigational and dual-task walking (condition 1 and 2 together)
Parkinson's disease; Elderly with Parkinson's disease	Other: No intervention; Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.; Dual-task walking with the auditory stroop task.; Navigational walking - a course consisting of a distribution of 45 and 90 degrees turns to the left and right; Navigational and dual-task walking (condition 1 and 2 together)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function- composite score	The cognitive test battery comprised the following tests: The Color-Word Interference Test (CWIT), Verbal Fluency, Trail Making Test (TMT) and Ray Auditory Verbal Learning Test (RAVLT). Cognitive function will be assessed as a composite measure of these test together.	During the test session, takes about 50 minutes
Cognitive function - verbal fluency	Verbal function, initiation & task-set switching with the Verbal Fluency test from D-KEFS (Delis-Kaplan Executive Function System)	During the test session, takes about 12 minutes
Cognitive function - Attention and psychomotor processing speed	Attention and psychomotor processing speed will be assessed with the Trail Making Test (TMT) from D-KEFS (Delis-Kaplan Executive Function System)	During the test session, takes about 3 minutes
Cognitive function - Episodic memory	Episodic memory will be assessed with the Ray Auditory Verbal Learning Test (RAVLT).	During the test session, takes about 30 minutes
Cognitive function - Inhibition & task-set switching	Inhibition & task-set switching with the The Color-Word Interference Test (CWIT) from D-KEFS (Delis-Kaplan Executive Function System)	During the test session, takes about 5 minutes
Self-reported level of physical activity	Assessed with the Frändin-Grimby Scale (score 1-6, higher score=better)	Through study completion, an average of 1 year
Physical activity level and intensity	Assessed with accelerometers (Actigraph GT3X+)	For one week after the test session
Motor function/disease severity	Assessed with the movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Higher scores = worse/more symptoms	During the test session
Balance performance	Assessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p,	During the test session
Anxiety and depression	Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better	Will be answered before the test session in the patients home or during the test session
Walking ability	Self assessed walking ability with the WALK-12G	Will be answered before the test session in the patients home or at the test session
Dual-task performance -errors	Cognitive performance of the dual task will be assessed as the reaction time to respond during Auditory stroop	During the test session during dual task conditions
Disability	WHO Disability Assessment Schedule (WHODAS) version 2.0, 12 self-assessed questions (12 to 60) more points=worse	Will be answered before the test session in the patients home or during the test session

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Erika Franzén, PhD, Karollinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 29, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; gait; functional near infrared spectrometry
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 2020-03059 (Ethical permit)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: We plan to share this when applicable on OSF or similar
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No