StraDiMS: Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis

Sponsor
Hasselt University (Other)
Overall Status
Completed
CT.gov ID
NCT04538872
Collaborator
National MS Center Melsbroek (Other), Revalidatie & MS Centrum Overpelt (Other)
37
2
4
7.9
18.5
2.3

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: StraDiMS implicit
  • Behavioral: StraDiMs explicit
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: MS group implicit

Behavioral: StraDiMS implicit
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.

Experimental: MS group explicit

Behavioral: StraDiMs explicit
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.

Active Comparator: HC group implicit (Healthy Controls)

Behavioral: StraDiMS implicit
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.

Active Comparator: HC group explicit (Healthy controls)

Behavioral: StraDiMs explicit
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.

Outcome Measures

Primary Outcome Measures

  1. Dual task (STEP + substraction sevens) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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 [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) [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 Outcome Measures

  1. Age [day 1]

  2. height [day 1]

  3. weight [day 1]

  4. educational level questionnaire [day 1]

  5. date of diagnosis questionnaire [day 1]

  6. type of MS questionnaire [day 1]

  7. EDSS [day 1]

    Expanded Disability Status Scale (EDSS)

  8. Digit span forwards visually [day 1]

  9. Brief Visuospatial Memory Test (BVMT) [day 1]

  10. 10/36 Spatial Recall test (SPART) [day 1]

  11. Symbol Digit Modalities Test (SDMT) [day 1]

  12. Paced Auditory Serial Addition Test (PASAT)-3 seconds [day 1]

  13. Digit Span backwards auditory [day 1]

  14. 6 minute walking test (6MWT) [day 1]

  15. Timed-Up and Go (TUG) [day 1]

  16. Timed 25 Foot Walk (T25FW) [day 1]

  17. 4 square stepping test (FSST) [day 1]

  18. Berg Balance Scale (BBS) [day 1]

  19. Tandem Walk 3m [day 1]

  20. Motricity Index [day 1]

  21. Movement specific reinvestment scale (MSRS) [day 1]

  22. MS Neuropsychological screening questionnaire (MSNQ) [day 1]

  23. Multiple Sclerosis Walking Scale (MSWS-12) [day 1]

  24. Modified fatigue impact scale (MFIS) [day 1]

  25. Activities-specific Balance Confidence scale (ABC) [day 1]

  26. Dual Task Questionnaire (DTQ) [day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Noorderhart Overpelt Belgium 3900
2 National MS Center Melsbroek Steenokkerzeel Belgium 1820

Sponsors and Collaborators

  • Hasselt University
  • National MS Center Melsbroek
  • Revalidatie & MS Centrum Overpelt

Investigators

  • Principal Investigator: Peter Feys, prof. dr., Hasselt University
  • Study Chair: Renee Veldkamp, drs., Hasselt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Feys, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier:
NCT04538872
Other Study ID Numbers:
  • StraDiMS-001
First Posted:
Sep 4, 2020
Last Update Posted:
Sep 2, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2021