Walking and Thinking - Brain Activity During Complex Walking in Stroke

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

Everyday life requires individuals to function in complex environments and perform tasks that involve the integration of motor and cognitive abilities. However, stroke often leads to impairments in motor-cognitive interaction, which can negatively affect mobility, balance, attention, and the ability to live independently. Although motor-cognitive performance has been identified as an important rehabilitation target after stroke, limited knowledge exists regarding the underlying brain function associated with these difficulties and how rehabilitation and exercise interventions can best address them.

Improving treatment for motor-cognitive difficulties after stroke, such as dual-task walking and navigation, remains a major challenge. An important step is developing assessment methods that accurately capture these impairments in ecologically valid settings that reflect real-world mobility demands. The investigators therefore aim to explore brain function during complex walking after stroke by investigating motor-cognitive performance and its neural correlates during three walking conditions: dual-task walking, navigation, and a combination of both. Non-invasive measures of brain activity using functional near-infrared spectroscopy (fNIRS) together with advanced real-time gait analysis will be used to better understand how stroke affects motor-cognitive functioning during complex walking tasks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

with a stroke ≥6 months confirmed by a clinical diagnosis

with the ability to walk with or without a walking aid for ≥ 5 min

Disqualifiers

Individuals post stroke with cognitive impairment

severe neglect

global aphasia affecting the ability to provide written informed consent

severe perceptual problems or severe freezing of gait

Trial population

We are studying complex walking in four different populations, people with stroke, healthy adults, people with Parkinson's disease and people with Multiple Sclerosis. We have during 2022-2025 completed data collection (ClinicalTrials.gov ID: NCT06906276, NCT05218213 and NCT05787704) of healthy adults, people with Parkinson's disease and people with Multiple Sclerosis. Hence, this registration concerns the stroke cohort

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • No Interventions

    Other intervention

    This study includes assessment of brain activity with functional Near Infrared Spectrscopy (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)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Individuals with a stroke ≥ 6 months1 intervention

Trial outcomes

Primary outcomes

1

Functional near infrared spectrometry (fNIRS)

The measurement of changes in concentration of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HHb) in the prefrontal cortex will be assessed using a NIRSPORT 2 (NIRx Medizintechnik, Berlin, Germany) device.

Time frame
Baseline
2

Stride time during all conditions

Stride time will be analyzed with the APDM mobility system.

Time frame
Baseline
3

Velocity during all conditions

Velocity will be analyzed with the APDM mobility system.

Time frame
Baseline
4

Dual-task performance-reaction time

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

Time frame
Baseline

Secondary outcomes

1

Cognitive performance

Global cognitive performance will be assessed with the Montreal Cognitive Assessment (MoCA). Scores range from 0-30, with higher score indicating better performance.

Time frame
Baseline
2

Stroke severity

Assessed using the National Institutes of Health Stroke Scale (NIHSS). Scores range from 0-42, with higher scores indicating greater stroke severity.

Time frame
Baseline
3

Stroke specific health status

Assessed using the Stroke Impact Scale (SIS). Scores range from 0-100, with higher scores indicating better functioning

Time frame
Baseline
4

Physical Impairment

Assessed using the Chedoke McMaster Stroke Assessment. Scores range from 1-7 for each impairment dimension, with higher scores indicating better motor recovery.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Karolinska University Hospital

Collaborator