Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— StraDiMS  

Official title:

Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538872
• Other study ID #: StraDiMS-001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2021
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Noorderhart	Overpelt
Belgium	National MS Center Melsbroek	Steenokkerzeel

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	day 2
Primary	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).	day 4
Primary	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).	day 2
Primary	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).	day 4
Primary	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).	day 2
Primary	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).	day 4
Primary	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.	day 2
Primary	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.	day 4
Primary	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.	day 2
Primary	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.	day 4
Primary	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.	day 2
Primary	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.	day 4
Primary	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).	Day 3
Primary	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.	day 4
Secondary	Age		day 1
Secondary	height		day 1
Secondary	weight		day 1
Secondary	educational level questionnaire		day 1
Secondary	date of diagnosis questionnaire		day 1
Secondary	type of MS questionnaire		day 1
Secondary	EDSS	Expanded Disability Status Scale (EDSS)	day 1
Secondary	Digit span forwards visually		day 1
Secondary	Brief Visuospatial Memory Test (BVMT)		day 1
Secondary	10/36 Spatial Recall test (SPART)		day 1
Secondary	Symbol Digit Modalities Test (SDMT)		day 1
Secondary	Paced Auditory Serial Addition Test (PASAT)-3 seconds		day 1
Secondary	Digit Span backwards auditory		day 1
Secondary	6 minute walking test (6MWT)		day 1
Secondary	Timed-Up and Go (TUG)		day 1
Secondary	Timed 25 Foot Walk (T25FW)		day 1
Secondary	4 square stepping test (FSST)		day 1
Secondary	Berg Balance Scale (BBS)		day 1
Secondary	Tandem Walk 3m		day 1
Secondary	Motricity Index		day 1
Secondary	Movement specific reinvestment scale (MSRS)		day 1
Secondary	MS Neuropsychological screening questionnaire (MSNQ)		day 1
Secondary	Multiple Sclerosis Walking Scale (MSWS-12)		day 1
Secondary	Modified fatigue impact scale (MFIS)		day 1
Secondary	Activities-specific Balance Confidence scale (ABC)		day 1
Secondary	Dual Task Questionnaire (DTQ)		day 1