Walking and Thinking - Brain Activity During Complex Walking in Stroke

NCT07624630 | Recruiting

• 2 other identifiers: 4-1349/20262020-03059
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Aging; Neuro-Degenerative Disease; Gait Impairment in Stroke Patients

Keywords

Stroke; Dual task walking; navigated walking; motor-cognitive interference; funtional Near Infrared Spectroscopy (fNIRS); brain funtion

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline

• Stride time during all conditions

  Stride time will be analyzed with the APDM mobility system.

  Baseline

• Velocity during all conditions

  Velocity will be analyzed with the APDM mobility system.

  Baseline

• Dual-task performance-reaction time

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

  Baseline

Secondary Outcomes (14)

• Cognitive performance

  Baseline

• Stroke severity

  Baseline

• Stroke specific health status

  Baseline

• Physical Impairment

  Baseline

• Walking ability

  Baseline

Study Arms (1)

Individuals with a stroke ≥ 6 months

Other: No Interventions

Interventions

No Interventions OTHER

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)

Individuals with a stroke ≥ 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

uMOVE core facility, Karolinska Institutet and Karolinska University hospital

Solna, Stockholm County, 17177, Sweden

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Compliance Office Karolinska Insitutet

CONTACT

+46852480000; compliance@ki.se

Erika Franzén, PhD professor

CONTACT

+46852488878; erika.franzen@ki.se

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: May 13, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

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.

Locations

SE (1)