Multiple Sclerosis
Conditions
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.
Interventions
BEHAVIORALStraDiMS 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.
BEHAVIORALStraDiMs 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.
Sponsors
National MS Center Melsbroek
Revalidatie & MS Centrum Overpelt
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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). |
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Brief Visuospatial Memory Test (BVMT) | day 1 | — |
| 10/36 Spatial Recall test (SPART) | day 1 | — |
| Symbol Digit Modalities Test (SDMT) | day 1 | — |
| Paced Auditory Serial Addition Test (PASAT)-3 seconds | day 1 | — |
| Digit Span backwards auditory | day 1 | — |
| 6 minute walking test (6MWT) | day 1 | — |
| Timed-Up and Go (TUG) | day 1 | — |
| Timed 25 Foot Walk (T25FW) | day 1 | — |
| 4 square stepping test (FSST) | day 1 | — |
| Age | day 1 | — |
| Tandem Walk 3m | day 1 | — |
| Motricity Index | day 1 | — |
| Movement specific reinvestment scale (MSRS) | day 1 | — |
| MS Neuropsychological screening questionnaire (MSNQ) | day 1 | — |
| Multiple Sclerosis Walking Scale (MSWS-12) | day 1 | — |
| Modified fatigue impact scale (MFIS) | day 1 | — |
| Activities-specific Balance Confidence scale (ABC) | day 1 | — |
| Dual Task Questionnaire (DTQ) | day 1 | — |
| Berg Balance Scale (BBS) | day 1 | — |
| height | day 1 | — |
| weight | day 1 | — |
| educational level questionnaire | day 1 | — |
| date of diagnosis questionnaire | day 1 | — |
| type of MS questionnaire | day 1 | — |
| EDSS | day 1 | Expanded Disability Status Scale (EDSS) |
| Digit span forwards visually | day 1 | — |
Countries
Belgium
Outcome results
None listed