Clinical trial NCT04538872: Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis
Official title: Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: National MS Center Melsbroek
name: Revalidatie & MS Centrum Overpelt
First posted: 2020-09-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dual task (STEP + substraction sevens)
timeFrame: day 2
measure: Dual task (STEP + substraction sevens)
timeFrame: day 4
measure: Dual task (STEP + phonetic word list generation)
timeFrame: day 2
measure: Dual task (STEP + phonetic word list generation)
timeFrame: day 4
measure: Dual task (STEP + Auditory vigilance)
timeFrame: day 2
measure: Dual task (STEP + Auditory vigilance)
timeFrame: day 4
measure: Dual Task (WALK + Subtraction sevens)
timeFrame: day 2
measure: Dual Task (WALK + Subtraction sevens)
timeFrame: day 4
measure: Dual Task (WALK + Word list generation (phonetic)
timeFrame: day 2
measure: Dual Task (WALK + Word list generation (phonetic)
timeFrame: day 4
measure: Dual Task (WALK + Auditory vigilance)
timeFrame: day 2
measure: Dual Task (WALK + Auditory vigilance)
timeFrame: day 4
measure: learning measure
timeFrame: Day 3
measure: fNIRS measure (functional near-infrared spectroscopy)
timeFrame: day 4
Secondary outcomes:
measure: Age
timeFrame: day 1
measure: height
timeFrame: day 1
measure: weight
timeFrame: day 1
measure: educational level questionnaire
timeFrame: day 1
measure: date of diagnosis questionnaire
timeFrame: day 1
measure: type of MS questionnaire
timeFrame: day 1
measure: EDSS
timeFrame: day 1
measure: Digit span forwards visually
timeFrame: day 1
measure: Brief Visuospatial Memory Test (BVMT)
timeFrame: day 1
measure: 10/36 Spatial Recall test (SPART)
timeFrame: day 1
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: day 1
measure: Paced Auditory Serial Addition Test (PASAT)-3 seconds
timeFrame: day 1
measure: Digit Span backwards auditory
timeFrame: day 1
measure: 6 minute walking test (6MWT)
timeFrame: day 1
measure: Timed-Up and Go (TUG)
timeFrame: day 1
measure: Timed 25 Foot Walk (T25FW)
timeFrame: day 1
measure: 4 square stepping test (FSST)
timeFrame: day 1
measure: Berg Balance Scale (BBS)
timeFrame: day 1
measure: Tandem Walk 3m
timeFrame: day 1
measure: Motricity Index
timeFrame: day 1
measure: Movement specific reinvestment scale (MSRS)
timeFrame: day 1
measure: MS Neuropsychological screening questionnaire (MSNQ)
timeFrame: day 1
measure: Multiple Sclerosis Walking Scale (MSWS-12)
timeFrame: day 1
measure: Modified fatigue impact scale (MFIS)
timeFrame: day 1
measure: Activities-specific Balance Confidence scale (ABC)
timeFrame: day 1
measure: Dual Task Questionnaire (DTQ)
timeFrame: day 1
Other outcomes:
Locations:
city: Overpelt
country: Belgium
facility: Noorderhart
city: Steenokkerzeel
country: Belgium
facility: National MS Center Melsbroek
Study officials:
affiliation: Hasselt University
name: Peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Renee Veldkamp, drs.
role: STUDY_CHAIR
References: