NCT05218213

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

December 21, 2021

Last Update Submit

October 23, 2024

Conditions

Keywords

functional near infrared spectrometrygaitphysical activity

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

Other: No intervention

Healthy elderly

Healthy elderly adults

Other: No intervention

Parkinson's disease

Elderly with Parkinson's disease

Other: No intervention

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)

Healthy elderlyHealthy youngParkinson's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Study Sites (1)

Karolinska institutet

Stockholm, Solna, 17177, Sweden

Location

Related Links

MeSH Terms

Conditions

Parkinson DiseaseGait Disorders, NeurologicMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Erika Franzén, PhD

    Karollinska Institutet

    PRINCIPAL INVESTIGATOR

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

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.

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.

Locations