Clinical trial NCT04158063: Cognitive-motor Interference in Persons With MS
Official title: Cognitive-motor Interference in Persons With MS: Dual Task Assessment and Training - A Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
name: National MS Center Melsbroek
name: AZ Klina
name: Centre Hospitalier Universitaire de Liege
name: Masku Neurological Rehabilitation Centre
name: Tel Aviv University
name: Sheba Medical Center
name: AISM Rehabilitation Service of Genoa
First posted: 2019-11-08
Enrollment: 112
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: TREATMENT

Brief summary: Dual tasking such as walking while talking on the phone or while remembering a shopping list is very frequently required in everyday life. Cognitive-motor interference occurs when the performance capacity of a motor or cognitive task decreases when both are performed simultaneously (dual task) compared to single task execution being the so-called dual task cost (DTC). Over the past five years, in MS, (pilot) studies have been conducted in order to investigate the presence and magnitude of the CMI during walking. It was shown that, even in the early stages of the disease, when walking speed is not affected as a single motor task, pwMS slow down more than healthy controls when performing DT walking. Studies have not yet investigated the impact of the complexity of the motor task, on the DTC. Across studies, many different types of cognitive distractors were applied without any documentation of psychometric properties, such as test-retest reliability, making it not yet suited as experimental outcome measure. Results have also focused on the effects of DT on walking performance, while the performance of the cognitive task was rarely assessed. Also, the majority of studies did not document the cognitive function level of pwMS or even excluded patients with cognitive deficits. As such, the relation between cognitive deficits and dual task (cognitive-motor) performance is unclear.

Motor and cognitive impairment are currently also treated separately whereas real life performance very often requiring an integrated motor and cognitive function. So far, no studies in MS have investigated the effects of physical or cognitive exercises on DT performances, or investigated effects of integrated cognitive-motor dual task training (DTT). In elderly and other neurological conditions, superior effects of dual task training (DTT) on gait training have been suggested, but the evidence is not robust yet. All these studies suggest the feasibility of DTT on gait improvement and fall risk reduction, but further insights on factors identifying responders, and differential effect of cognitive distractors needs further elucidation.

This research consist of two parts that aim to investigate:

Part 1: Assessment

1. the magnitude of the dual task cost according to different types of cognitive distractors (information processing, memory, attention, etc.),
2. its reliability as experimental outcome measure and
3. its association with factors as severity of cognitive or motor dysfunction, quality of life and fatigue.

Part 2: Intervention

1. the effectiveness of cognitive-motor DT-based training programs compared to single modality training, on DT and ST performances (cognition and mobility)
2. whether dual task learning effects transfer to improvements in daily life and are sustained for 4 weeks without training
3. which patient profiles benefit most from the integrated cognitive-motor training
4. feasibility and usefulness of an adaptive, interactive ICT-guided DTT system.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS according to McDonald criteria
* EDSS ≥2 and ≤ 6
* No relapse within the last 30 days
* No changes in disease modifying treatment and no corticoid-therapy within the last 50 days
* All types of MS
* Minimal cognitive functioning (MMSE≥26)
* Presence of dual task interference (dual task screening list ≥1)

Exclusion Criteria:

* Other medical conditions interfering with mobility
* Other neurological diagnoses
* MS-like syndroms such as neruomyelitis optica
* Not able to understand and execute simple instructions
* Problems (even after adjustment with hearing aids or glasses) with hearing or vision interfering with the assessment or training.
* Ongoing dual task training or other interfering physical therapy or cognitive training/neuropsychological rehabilitation.

Primary outcomes:
measure: Digit Span - Walk - Dual Task Cost (%)
timeFrame: Baseline
measure: Digit Span - Walk - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Digit Span - Walk - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Subtraction - Walk - Dual Task Cost (%)
timeFrame: Baseline
measure: Subtraction - Walk - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Subtraction - Walk - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Vigilance - Walk - Dual Task Cost (%)
timeFrame: Baseline
measure: Vigilance - Walk - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Vigilance - Walk - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Digit Span - Cup - Dual Task Cost (%)
timeFrame: Baseline
measure: Digit Span - Cup - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Digit Span - Cup - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Subtraction - Cup - Dual Task Cost (%)
timeFrame: Baseline
measure: Subtraction - Cup - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Subtraction - Cup - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Vigilance - Cup - Dual Task Cost (%)
timeFrame: baseline
measure: Vigilance - Cup - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Vigilance - Cup - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Digit Span - Obstacles - Dual Task Cost (%)
timeFrame: Baseline
measure: Digit Span - Obstacles - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Digit Span - Obstacles - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Subtraction - Obstacles - Dual Task Cost (%)
timeFrame: Baseline
measure: Subtraction - Obstacles - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Subtraction - Obstacles - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Vigilance - Obstacles - Dual Task Cost (%)
timeFrame: Baseline
measure: Vigilance - Obstacles - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Vigilance - Obstacles - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Digit Span - Crisscross - Dual Task Cost (%)
timeFrame: baseline
measure: Digit Span - Crisscross - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Digit Span - Crisscross - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Subtraction - Crisscross - Dual Task Cost (%)
timeFrame: Baseline
measure: Subtraction - Crisscross - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Subtraction - Crisscross - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
measure: Vigilance - Crisscross - Dual Task Cost (%)
timeFrame: Baseline
measure: Vigilance - Crisscross - Dual Task Cost (%)
timeFrame: Week 9 (post-measure)
measure: Vigilance - Crisscross - Dual Task Cost (%)
timeFrame: week 13 (4-week follow-up)
Secondary outcomes:
measure: Brief Repeatable Battery of Neuropsychological Tests
timeFrame: baseline
measure: Part of Brief Repeatable Battery of Neuropsychological Tests
timeFrame: Week 9 (post-measure)
measure: Part of Brief Repeatable Battery of Neuropsychological Tests
timeFrame: week 13 (4-week follow-up)
measure: Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: baseline
measure: Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: Week 9 (post-measure)
measure: Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: week 13 (4-week follow-up)
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: baseline
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Week 9 (post-measure)
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: week 13 (4-week follow-up)
measure: Dual Task Questionnaire
timeFrame: Baseline
measure: Dual Task Questionnaire
timeFrame: Week 9 (post-measure)
measure: Dual Task Questionnaire
timeFrame: week 13 (4-week follow-up)
measure: Timed 25 Foot-walk test (T25FW)
timeFrame: baseline
measure: Timed 25 Foot-walk test (T25FW)
timeFrame: Week 9 (post-measure)
measure: Timed 25 Foot-walk test (T25FW)
timeFrame: week 13 (4-week follow-up)
measure: Timed-up-and-go test (TUG)
timeFrame: baseline
measure: Timed-up-and-go test (TUG)
timeFrame: Week 9 (post-measure)
measure: Timed-up-and-go test (TUG)
timeFrame: week 13 (4-week follow-up)
measure: Dynamic Gait Index (DGI)
timeFrame: Baseline
measure: Dynamic Gait Index (DGI)
timeFrame: Week 9 (post-measure)
measure: Dynamic Gait Index (DGI)
timeFrame: week 13 (4-week follow-up)
measure: 2-minute walking test (2MWT)
timeFrame: baseline
measure: 2-minute walking test (2MWT)
timeFrame: Week 9 (post-measure)
measure: 2-minute walking test (2MWT)
timeFrame: week 13 (4-week follow-up)
measure: Multiple sclerosis walking scale-12 (MSWS-12)
timeFrame: baseline
measure: Multiple sclerosis walking scale-12 (MSWS-12)
timeFrame: Week 9 (post-measure)
measure: Multiple sclerosis walking scale-12 (MSWS-12)
timeFrame: week 13 (4-week follow-up)
measure: Falls efficacy scale (FES-I)
timeFrame: baseline
measure: Falls efficacy scale (FES-I)
timeFrame: Week 9 (post-measure)
measure: Falls efficacy scale (FES-I)
timeFrame: week 13 (4-week follow-up)
Other outcomes:
Locations:
city: Overpelt
country: Belgium
facility: Revalidatie & MS Centrum Overpelt
Study officials:
affiliation: Hasselt University
name: Peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Ilse Baert, drs.
role: STUDY_CHAIR
affiliation: Hasselt University
name: Renee Veldkamp, drs.
role: STUDY_CHAIR
References: