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Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis (StraDiMS)

H

Hasselt University

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Behavioral: StraDiMs explicit
Behavioral: StraDiMS implicit

Study type

Interventional

Funder types

Other

Identifiers

NCT04538872
StraDiMS-001

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

37 participants in 4 patient groups

MS group implicit
Experimental group
Treatment:
Behavioral: StraDiMS implicit
MS group explicit
Experimental group
Treatment:
Behavioral: StraDiMs explicit
HC group implicit (Healthy Controls)
Active Comparator group
Treatment:
Behavioral: StraDiMS implicit
HC group explicit (Healthy controls)
Active Comparator group
Treatment:
Behavioral: StraDiMs explicit

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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