Cognitive-motor Interference in Persons With MS

NCT ID: NCT04158063

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-10
• Study Completion Date: 2018-07-01

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dual Task Training (DTT)

Group Type: EXPERIMENTAL

Dual Task Training

Intervention Type: BEHAVIORAL

In total 12 Dual Task conditions will be performed in which 3 cognitive tasks are combined with 4 motor tasks:

Cognitive tasks:

• Titrated digit span backwards
• Auditory vigilance with alphabets
• Subtracting by 7

Motor tasks:

• Walking at self-selected speed
• Walking while carrying a cup of water
• Walking while stepping over obstacles
• Walking crisscross

Single Mobility Training (SMT)

Group Type: ACTIVE_COMPARATOR

Single Mobility Training

Intervention Type: OTHER

standard routine training

Interventions

Dual Task Training

In total 12 Dual Task conditions will be performed in which 3 cognitive tasks are combined with 4 motor tasks:

Cognitive tasks:

• Titrated digit span backwards
• Auditory vigilance with alphabets
• Subtracting by 7

Motor tasks:

• Walking at self-selected speed
• Walking while carrying a cup of water
• Walking while stepping over obstacles
• Walking crisscross

Intervention Type: BEHAVIORAL

Single Mobility Training

standard routine training

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Revalidatie & MS Centrum Overpelt

OTHER

Sponsor Role: collaborator

National MS Center Melsbroek

OTHER

Sponsor Role: collaborator

AZ Klina

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role: collaborator

Masku Neurological Rehabilitation Centre

UNKNOWN

Sponsor Role: collaborator

Tel Aviv University

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: collaborator

AISM Rehabilitation Service of Genoa

UNKNOWN

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Peter Feys

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Feys, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Ilse Baert, drs.

Role: STUDY_CHAIR

Hasselt University

Renee Veldkamp, drs.

Role: STUDY_CHAIR

Hasselt University

Locations

Revalidatie & MS Centrum Overpelt

Overpelt, , Belgium

Countries

Belgium

Other Identifiers

MCS-IV-CMI&DTT-01

Identifier Type: -

Identifier Source: org_study_id