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

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT05218213
Collaborator
Karolinska University Hospital (Other)
120
1
22.3
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Walking and Thinking - Brain Activity During Complex Walking in Aging and Parkinson's Disease (Part of the ParkMOVE Trial)
Actual Study Start Date :
Jan 21, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Functional near infrared spectrometry (fNIRS) [During the test session during all three conditions]

    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

  2. Gait performance during all conditions [During the test session during all three conditions]

    Gait variables such as stride time and/or velocity will be analyzed with the APDM mobility system.

  3. Dual-task performance-reaction time [During the test session during dual task conditions]

    Cognitive performance of the dual task will be assessed as errors in the response to the Auditory stroop task.

Secondary Outcome Measures

  1. Cognitive function- composite score [During the test session, takes about 50 minutes]

    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.

  2. Cognitive function - verbal fluency [During the test session, takes about 12 minutes]

    Verbal function, initiation & task-set switching with the Verbal Fluency test from D-KEFS (Delis-Kaplan Executive Function System)

  3. Cognitive function - Attention and psychomotor processing speed [During the test session, takes about 3 minutes]

    Attention and psychomotor processing speed will be assessed with the Trail Making Test (TMT) from D-KEFS (Delis-Kaplan Executive Function System)

  4. Cognitive function - Episodic memory [During the test session, takes about 30 minutes]

    Episodic memory will be assessed with the Ray Auditory Verbal Learning Test (RAVLT).

  5. Cognitive function - Inhibition & task-set switching [During the test session, takes about 5 minutes]

    Inhibition & task-set switching with the The Color-Word Interference Test (CWIT) from D-KEFS (Delis-Kaplan Executive Function System)

  6. Self-reported level of physical activity [Through study completion, an average of 1 year]

    Assessed with the Frändin-Grimby Scale (score 1-6, higher score=better)

  7. Physical activity level and intensity [For one week after the test session]

    Assessed with accelerometers (Actigraph GT3X+)

  8. Motor function/disease severity [During the test session]

    Assessed with the movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Higher scores = worse/more symptoms

  9. Balance performance [During the test session]

    Assessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p,

  10. Anxiety and depression [Will be answered before the test session in the patients home or during the test session]

    Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better

  11. Walking ability [Will be answered before the test session in the patients home or at the test session]

    Self assessed walking ability with the WALK-12G

  12. Dual-task performance -errors [During the test session during dual task conditions]

    Cognitive performance of the dual task will be assessed as the reaction time to respond during Auditory stroop

  13. Disability [Will be answered before the test session in the patients home or during the test session]

    WHO Disability Assessment Schedule (WHODAS) version 2.0, 12 self-assessed questions (12 to 60) more points=worse

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska institutet Stockholm Solna Sweden 17177

Sponsors and Collaborators

  • Karolinska Institutet
  • Karolinska University Hospital

Investigators

  • Principal Investigator: Erika Franzén, PhD, Karollinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erika Franzén, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT05218213
Other Study ID Numbers:
  • 2020-03059
First Posted:
Feb 1, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erika Franzén, Professor, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022