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Walking and Thinking - Brain Activity During Complex Walking in People With Multiple Sclerosis

Completed
Conditions
Gait Disorders, Neurologic
Neuro-Degenerative Disease
Multiple Sclerosis
Aging
Interventions
Other: No intervention
Registration Number
NCT05787704
Lead Sponsor
Karolinska Institutet
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 Multiple Sclerosis (MS) 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 MS (in comparison with people with Parkinson's disease and healthy controls) by investigating the effects of 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 people with MS (in comparison with people with Parkinson's disease and healthy adults).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
Inclusion Criteria
  • 18 years or older
  • with an MS diagnosis according to McDonald criteria
  • with the ability to walk without a mobility device for ≥5 minutes continuously.
Exclusion Criteria
  • Disease or condition that affects cognition, gait or balance.
  • MS relapse or change of disease-modifying treatment within the past eight weeks.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Multiple SclerosisNo interventionPeople with Multiple Sclerosis, 18 years or older
Primary Outcome Measures
NameTimeMethod
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.

Gait performance during all conditionsDuring the test session during all three conditions

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

Dual-task performance-reaction timeDuring the test session during complex walking condition 1 and 3

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

Secondary Outcome Measures
NameTimeMethod
Cognitive function- composite scoreDuring 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) and Symbol Digit Modalities Test (SDMT). Cognitive function will be assessed as a composite measure of these test together.

Anxiety and depressionWill 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

Cognitive function - verbal fluencyDuring 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).

Overall MS-disabilityDuring the test session

Assessed with the Expanded Disability Status Scale (EDSS). Higher scores=worse/more severe disability

Walking abilityWill be answered before the test session in the patients home or at the test session

Self-assessed walking ability with the WALK-12G.

DisabilityWill 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

Physical activity level and intensityFor one week after the test session

Assessed with accelerometers (Actigraph GT3X+)

Dual-task performance -errorsDuring 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

Impact of MS on healthWill be answered before the test session in the patients home or during the test session

Self-assessed physical and psychological impact of MS on health. 29 items, rated from 1 to 5. Higher score indicates perceived worse physical or psychological impacts of MS, respectively, on health.

Cognitive function - Attention and psychomotor processing speedDuring 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).

Cognitive function - Episodic memoryDuring the test session, takes about 30 minutes

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

Cognitive function - Cognitive processing speedDuring the test session, takes about 3 minutes

Cognitive processing speed will be assessed with the Symbol Digit Modalities Test (SDMT)

Cognitive function - Inhibition & task-set switchingDuring 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).

Self-reported level of physical activityWill be answered before the test session in the patients home or during the test session

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

Balance performanceDuring the test session

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

Impact of FatigueWill be answered before the test session in the patients home or during the test session

Self-assessed impact of fatigue on physical, cognitive, and psychosocial functioning, with the Modified Fatigue Impact Scale (MFIS). 21 items, scored from 0 to 4. Higher scores indicate a larger impact of fatigue.

Trial Locations

Locations (1)

Karolinska Institutet

🇸🇪

Stockholm, Solna, Sweden

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