Multiple SclerosisStraDiMSNCT04538872
Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis
A study testing StraDiMS implicit and StraDiMs explicit in people with Multiple Sclerosis, run by Hasselt University at 2 sites in Belgium.
Trial summary
This study is a randomized controlled study in which we aim to include 60 persons with Multiple Sclerosis and 30 healthy controls. Two different learning strategies, an explicit and an implicit one, will be compared on effects on dual task performance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- StraDiMS implicit and StraDiMs explicit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all participants: minimal cognitive function (MoCA ≥ 26)
- Persons with MS:
- Diagnosis of MS
- EDSS 2.0 - 5.5
- No relapse within the past 30 days.
- Able to walk minimally 6 minutes consecutively and to step over the stepping platform without aid.
Who cannot join
- Other medical conditions interfering with mobility.
- Other neurological conditions.
- Not able to understand instructions.
- Major (unresolvable) problems with hearing or vision.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Noorderhart
Overpelt, 3900
National MS Center Melsbroek
Steenokkerzeel, 1820
About this study
This study is a randomized controlled study in which we aim to include 60 persons with Multiple Sclerosis and 30 healthy controls. Two different learning strategies, an explicit and an implicit one, will be compared on effects on dual task performance. Further, clinical profile associated with these effects, and brain activity measured by functional near-infrared spectroscopy during dual tasking will be investigated.
To this end, the study will cover 4 days:
Read more
Day 1: examine clinical profile; Day 2: baseline dual task measures; Day 3: experimental learning paradigm with subjects randomly assigned to either the implicit or the explicit learning condition.
Day 4: delayed retention dual task and fNIRS measures.
- Conditions
- Multiple Sclerosis
- Being tested
- StraDiMS implicit, StraDiMs explicit
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StraDiMS implicitBehavioural
participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
StraDiMs explicitBehavioural
participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
| Study group | Role | What they receive |
|---|---|---|
| MS group implicit | Experimental | Not described Receives: Behavioral: StraDiMS implicit |
| MS group explicit | Experimental | Not described Receives: Behavioral: StraDiMs explicit |
| HC group implicit (Healthy Controls) | Active comparator | Not described Receives: Behavioral: StraDiMS implicit |
| HC group explicit (Healthy controls) | Active comparator | Not described Receives: Behavioral: StraDiMs explicit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual task (STEP + substraction sevens)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).
Measured: day 2
Dual task (STEP + substraction sevens)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).
Measured: day 4
Dual task (STEP + phonetic word list generation)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).
Measured: day 2
Dual task (STEP + phonetic word list generation)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).
Measured: day 4
Dual task (STEP + Auditory vigilance)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).
Measured: day 2
Dual task (STEP + Auditory vigilance)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).
Measured: day 4
Dual Task (WALK + Subtraction sevens)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.
Measured: day 2
Dual Task (WALK + Subtraction sevens)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.
Measured: day 4
Dual Task (WALK + Word list generation (phonetic)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.
Measured: day 2
Dual Task (WALK + Word list generation (phonetic)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.
Measured: day 4
Dual Task (WALK + Auditory vigilance)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.
Measured: day 2
Dual Task (WALK + Auditory vigilance)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.
Measured: day 4
learning measure
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. The outcome measure on this task is response time (time from the moment the tile lights up, until the participant steps on the tile).
Measured: Day 3
fNIRS measure (functional near-infrared spectroscopy)
a block-design test with 3 tasks (cognitive ST, motor ST and DT) of 25 seconds per task-block (repeated 5 times) will be conducted with a functional near-infrared spectroscopy (fNIRS) neuroimaging system to measure hemoglobin changes during performance of the task and compared between single task and dual task conditions and between groups. Besides, fNIRS will be used during 1 task related to the learning-paradigm.
Measured: day 4
Secondary outcomes (26)
Age
Measured: day 1
height
Measured: day 1
weight
Measured: day 1
educational level questionnaire
Measured: day 1
date of diagnosis questionnaire
Measured: day 1
type of MS questionnaire
Measured: day 1
EDSS
Expanded Disability Status Scale (EDSS)
Measured: day 1
Digit span forwards visually
Measured: day 1
Brief Visuospatial Memory Test (BVMT)
Measured: day 1
10/36 Spatial Recall test (SPART)
Measured: day 1
Symbol Digit Modalities Test (SDMT)
Measured: day 1
Paced Auditory Serial Addition Test (PASAT)-3 seconds
Measured: day 1
Digit Span backwards auditory
Measured: day 1
6 minute walking test (6MWT)
Measured: day 1
Timed-Up and Go (TUG)
Measured: day 1
Timed 25 Foot Walk (T25FW)
Measured: day 1
4 square stepping test (FSST)
Measured: day 1
Berg Balance Scale (BBS)
Measured: day 1
Tandem Walk 3m
Measured: day 1
Motricity Index
Measured: day 1
Movement specific reinvestment scale (MSRS)
Measured: day 1
MS Neuropsychological screening questionnaire (MSNQ)
Measured: day 1
Multiple Sclerosis Walking Scale (MSWS-12)
Measured: day 1
Modified fatigue impact scale (MFIS)
Measured: day 1
Activities-specific Balance Confidence scale (ABC)
Measured: day 1
Dual Task Questionnaire (DTQ)
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Sep 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feys, prof. dr., Principal investigator, Hasselt UniversityRenee Veldkamp, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538872
- Sponsor's protocol ID
- StraDiMS-001
- Acronym
- StraDiMS
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04538872
- Acronym / sponsor ID
- StraDiMS / StraDiMS-001
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled study in which we aim to include 60 persons with Multiple Sclerosis and 30 healthy controls. Two different learning strategies, an explicit and an implicit one, will be compared on effects on dual task performance. Further, clinical profile associated with these effects, and brain activity measured by functional near-infrared spectroscopy during dual tasking will be investigated.
To this end, the study will cover 4 days:
Day 1: examine clinical profile; Day 2: baseline dual task measures; Day 3: experimental learning paradigm with subjects randomly assigned to either the implicit or the explicit learning condition.
Day 4: delayed retention dual task and fNIRS measures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MS group implicit | Experimental | Behavioral: StraDiMS implicit |
| MS group explicit | Experimental | Behavioral: StraDiMs explicit |
| HC group implicit (Healthy Controls) | Active comparator | Behavioral: StraDiMS implicit |
| HC group explicit (Healthy controls) | Active comparator | Behavioral: StraDiMs explicit |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- all participants: minimal cognitive function (MoCA ≥ 26)
- Persons with MS:
Key exclusion criteria (4 listed)
- Other medical conditions interfering with mobility.
- Other neurological conditions.
- Not able to understand instructions.
- Major (unresolvable) problems with hearing or vision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StraDiMS implicitparticipants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former. | Behavioural | HC group implicit (Healthy Controls), MS group implicit |
| StraDiMs explicitparticipants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former. | Behavioural | HC group explicit (Healthy controls), MS group explicit |
Primary outcome
Dual task (STEP + substraction sevens)
Time frame: day 2
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + substraction sevens)
Time frame: day 4
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + phonetic word list generation)
Time frame: day 2
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + phonetic word list generation)
Time frame: day 4
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + Auditory vigilance)
Time frame: day 2
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + Auditory vigilance)
Time frame: day 4
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).
Dual Task (WALK + Subtraction sevens)
Time frame: day 2
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.
Dual Task (WALK + Subtraction sevens)
Time frame: day 4
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.
Dual Task (WALK + Word list generation (phonetic)
Time frame: day 2
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.
Dual Task (WALK + Word list generation (phonetic)
Time frame: day 4
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.
Dual Task (WALK + Auditory vigilance)
Time frame: day 2
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.
Dual Task (WALK + Auditory vigilance)
Time frame: day 4
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.
learning measure
Time frame: Day 3
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. The outcome measure on this task is response time (time from the moment the tile lights up, until the participant steps on the tile).
fNIRS measure (functional near-infrared spectroscopy)
Time frame: day 4
a block-design test with 3 tasks (cognitive ST, motor ST and DT) of 25 seconds per task-block (repeated 5 times) will be conducted with a functional near-infrared spectroscopy (fNIRS) neuroimaging system to measure hemoglobin changes during performance of the task and compared between single task and dual task conditions and between groups. Besides, fNIRS will be used during 1 task related to the learning-paradigm.
26 secondary outcomes
Age
Time frame: day 1
height
Time frame: day 1
weight
Time frame: day 1
educational level questionnaire
Time frame: day 1
date of diagnosis questionnaire
Time frame: day 1
type of MS questionnaire
Time frame: day 1
EDSS
Time frame: day 1
Digit span forwards visually
Time frame: day 1
Brief Visuospatial Memory Test (BVMT)
Time frame: day 1
10/36 Spatial Recall test (SPART)
Time frame: day 1
Symbol Digit Modalities Test (SDMT)
Time frame: day 1
Paced Auditory Serial Addition Test (PASAT)-3 seconds
Time frame: day 1
Digit Span backwards auditory
Time frame: day 1
6 minute walking test (6MWT)
Time frame: day 1
Timed-Up and Go (TUG)
Time frame: day 1
Timed 25 Foot Walk (T25FW)
Time frame: day 1
4 square stepping test (FSST)
Time frame: day 1
Berg Balance Scale (BBS)
Time frame: day 1
Tandem Walk 3m
Time frame: day 1
Motricity Index
Time frame: day 1
Movement specific reinvestment scale (MSRS)
Time frame: day 1
MS Neuropsychological screening questionnaire (MSNQ)
Time frame: day 1
Multiple Sclerosis Walking Scale (MSWS-12)
Time frame: day 1
Modified fatigue impact scale (MFIS)
Time frame: day 1
Activities-specific Balance Confidence scale (ABC)
Time frame: day 1
Dual Task Questionnaire (DTQ)
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingPhase 3
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Feys, prof. dr. principal investigator
Hasselt University
Renee Veldkamp, drs. study chair
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StraDiMS implicit and StraDiMs explicit in people with Multiple Sclerosis, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual task (STEP + substraction sevens) (time frame: day 2). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.