Gait Disorders, NeurologicNCT06906276
Brain Activity During Complex Walking in People With Atypical Parkinsonian Syndromes
An observational study of Gait Disorders, Neurologic and Atypical Parkinson Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial 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 atypical Parkinson's disease (APD) compromises motor-cognitive interaction necessary for… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gait Disorders, Neurologic, Atypical Parkinson Disease, fNIRS
- What is being tested?
- Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 14 Mar 2025to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We are studying complex walking in different populations, such as people with Multiple Sclerosis, healthy young adults, healthy elderly, and elderly with Parkinson's disease. We have during 2022 completed data collection (ClinicalTrials.gov ID: NCT05218213) of healthy young adults, healthy elderly, and elderly with Parkinson's disease. In 2024, we completed data collection in people with Multiple Sclerosis (NCT05787704). Hence, this registration concerns the atypical parkinsonism cohort.
Who may be able to join
- clinical diagnosis of PSP according to Movement Disorder Society (MDS) (2017) or
- MSA according to MDS criteria (2022)
- the ability to walk with or without a mobility device for ≤5 minutes continuously
Who cannot join
- cognitive difficulties affecting the ability to understand and/or follow verbal/written - instructions
- severe freezing of gait
- Severe hearing or visual impairments that affect participation in the assessments
- Other neurological diseases
- Other diseases that can affect gait or balance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Solna, Solna, 17177
Erika Franzén, 0046737121593, erika.franzen@ki.se
About this study
Official title: Walking and Thinking - Brain Activity During Complex Walking in Atypical Parkinsonian Syndromes
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 atypical Parkinson's disease (APD) 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 ecologically valid state. The investigators aim therefore to explore brain function during complex walking in healthy and APD 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 older healthy adults and people with APD.
- Conditions
- Gait Disorders, Neurologic, Atypical Parkinson Disease, fNIRS, Aging
- Being tested
- Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.
- Medical subject headings
- Gait Disorders, Neurologic, Parkinson Disease, Familial, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.Other
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)
| Study group | Role | What they receive |
|---|---|---|
| Atypical Parkinsonian syndromes | -People with either Progressive supranuclear palsy or Multiple system atrophy Receives: Other: Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Gait performance during all conditions
Gait variables such as stride time and/or velocity will be analyzed with the APDM mobility system.
Measured: 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.
Measured: Baseline
Secondary outcomes (14)
Resting-state functional near infrared spectrometry (rsfNIRS)
The measurement of changes in concentration of HbO and HHb in the whole cortex will be assessed using a NIRSPORT 2 (NIRx Medizintechnik, Berlin, Germany) device during 2x 10min of rest, while seated in a comfortable chair.
Measured: Baseline
Cognitive function- composite score
The cognitive test battery comprised the following tests: The Color-Word Interference Test (CWIT), Verbal Fluency, Trail Making Test (TMT), Ray Auditory Verbal Learning Test (RAVLT), and Symbol Digit Modalities Test (SDMT). Cognitive function will be assessed as a composite measure of these tests together.
Measured: Baseline
Cognitive function - verbal fluency
Verbal function, initiation \& task-set switching with the Verbal Fluency test from D-KEFS (Delis-Kaplan Executive Function System).
Measured: Baseline
Cognitive function - Attention and psychomotor processing speed
Attention and psychomotor processing speed will be assessed with the Trail Making Test (TMT) from D-KEFS (Delis-Kaplan Executive Function System).
Measured: Baseline
Cognitive function - Episodic memory
Episodic memory will be assessed with the Ray Auditory Verbal Learning Test (RAVLT).
Measured: Baseline
Cognitive function - Inhibition & task-set switching
Inhibition \& task-set switching with the Color-Word Interference Test (CWIT) from D-KEFS (Delis-Kaplan Executive Function System)
Measured: Baseline
Self-reported level of physical activity
Assessed with the Frändin-Grimby Scale (score 1-6, higher score=better)
Measured: Baseline
Physical activity
Assessed with accelerometers (Actigraph GT3X+) for seven consecutive days after the clinical visit
Measured: Baseline
Motor function/disease severity
Assessed with the movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Higher scores = worse/more symptoms
Measured: Baseline
Balance performance
Assessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p,
Measured: Baseline
Anxiety and depression
Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better
Measured: Baseline
Walking ability
Self-assessed walking ability with the WALK-12G.
Measured: Baseline
Dual-task performance -errors
Cognitive performance of the dual task will be assessed as the reaction time to respond during the Auditory Stroop
Measured: Baseline
Disability
WHO Disability Assessment Schedule (WHODAS) version 2.0, 12 self-assessed questions (12 to 60) more points=worse
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start14 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Erika Franzén, Karolinska Institutet
- Investigators
- Franziska Albrecht, PhD, Principal investigator, Karolinska InstitutetErika Franzén, Prof,, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906276
- Sponsor's protocol ID
- 4-2452/2024
- Other IDs
- 2020-03059
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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, provided that the recipient has an approved ethics application.