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Completed

NCT Number: NCT04538872

Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noorderhart, Overpelt, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Other medical conditions interfering with mobility.
  • Other neurological conditions.
  • Not able to understand instructions.
  • Major (unresolvable) problems with hearing or vision.

Treatment and study plan

StraDiMS implicit

Behavioral

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 explicit

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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).

  14. 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.

Secondary outcomes

  1. Age

    Time frame: day 1

  2. height

    Time frame: day 1

  3. weight

    Time frame: day 1

  4. educational level questionnaire

    Time frame: day 1

  5. date of diagnosis questionnaire

    Time frame: day 1

  6. type of MS questionnaire

    Time frame: day 1

  7. EDSS

    Time frame: day 1

    Expanded Disability Status Scale (EDSS)

  8. Digit span forwards visually

    Time frame: day 1

  9. Brief Visuospatial Memory Test (BVMT)

    Time frame: day 1

  10. 10/36 Spatial Recall test (SPART)

    Time frame: day 1

  11. Symbol Digit Modalities Test (SDMT)

    Time frame: day 1

  12. Paced Auditory Serial Addition Test (PASAT)-3 seconds

    Time frame: day 1

  13. Digit Span backwards auditory

    Time frame: day 1

  14. 6 minute walking test (6MWT)

    Time frame: day 1

  15. Timed-Up and Go (TUG)

    Time frame: day 1

  16. Timed 25 Foot Walk (T25FW)

    Time frame: day 1

  17. 4 square stepping test (FSST)

    Time frame: day 1

  18. Berg Balance Scale (BBS)

    Time frame: day 1

  19. Tandem Walk 3m

    Time frame: day 1

  20. Motricity Index

    Time frame: day 1

  21. Movement specific reinvestment scale (MSRS)

    Time frame: day 1

  22. MS Neuropsychological screening questionnaire (MSNQ)

    Time frame: day 1

  23. Multiple Sclerosis Walking Scale (MSWS-12)

    Time frame: day 1

  24. Modified fatigue impact scale (MFIS)

    Time frame: day 1

  25. Activities-specific Balance Confidence scale (ABC)

    Time frame: day 1

  26. Dual Task Questionnaire (DTQ)

    Time frame: day 1

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • National MS Center Melsbroek
  • Revalidatie & MS Centrum Overpelt

Registry information

Acronym: StraDiMS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2020
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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