Cognitive-motor Interference in Persons With MS

NCT04158063 | Completed

• 1 other identifier: MCS-IV-CMI&DTT-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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. 1.the magnitude of the dual task cost according to different types of cognitive distractors (information processing, memory, attention, etc.),
2. 2.its reliability as experimental outcome measure and
3. 3.its association with factors as severity of cognitive or motor dysfunction, quality of life and fatigue.
4. 4.the effectiveness of cognitive-motor DT-based training programs compared to single modality training, on DT and ST performances (cognition and mobility)
5. 5.whether dual task learning effects transfer to improvements in daily life and are sustained for 4 weeks without training
6. 6.which patient profiles benefit most from the integrated cognitive-motor training
7. 7.feasibility and usefulness of an adaptive, interactive ICT-guided DTT system.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (36)

• Digit Span - Walk - Dual Task Cost (%)

  persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 - 5 4 1

  Baseline

• Digit Span - Walk - Dual Task Cost (%)

  persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 - 5 4 1

  Week 9 (post-measure)

• Digit Span - Walk - Dual Task Cost (%)

  persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 - 5 4 1

  week 13 (4-week follow-up)

• Subtraction - Walk - Dual Task Cost (%)

  persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.)

  Baseline

• Subtraction - Walk - Dual Task Cost (%)

  persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.)

  Week 9 (post-measure)

• Subtraction - Walk - Dual Task Cost (%)

  persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.)

  week 13 (4-week follow-up)

• Vigilance - Walk - Dual Task Cost (%)

  persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.

  Baseline

• Vigilance - Walk - Dual Task Cost (%)

  persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.

  Week 9 (post-measure)

• Vigilance - Walk - Dual Task Cost (%)

  persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.

  week 13 (4-week follow-up)

• Digit Span - Cup - Dual Task Cost (%)

  persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -\> 5 4 1).

  Baseline

• Digit Span - Cup - Dual Task Cost (%)

  persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -\> 5 4 1).

  Week 9 (post-measure)

• Digit Span - Cup - Dual Task Cost (%)

  persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -\> 5 4 1).

  week 13 (4-week follow-up)

• Subtraction - Cup - Dual Task Cost (%)

  persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.).

  Baseline

• Subtraction - Cup - Dual Task Cost (%)

  persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\>145 - 138 - 131, etc.).

  Week 9 (post-measure)

• Subtraction - Cup - Dual Task Cost (%)

  persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.).

  week 13 (4-week follow-up)

• Vigilance - Cup - Dual Task Cost (%)

  persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard

  baseline

• Vigilance - Cup - Dual Task Cost (%)

  persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard

  Week 9 (post-measure)

• Vigilance - Cup - Dual Task Cost (%)

  persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard

  week 13 (4-week follow-up)

• Digit Span - Obstacles - Dual Task Cost (%)

  persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -\> 5 4 1).

  Baseline

• Digit Span - Obstacles - Dual Task Cost (%)

  persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -\> 5 4 1).

  Week 9 (post-measure)

• Digit Span - Obstacles - Dual Task Cost (%)

  persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -\> 5 4 1).

  week 13 (4-week follow-up)

• Subtraction - Obstacles - Dual Task Cost (%)

  persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.).

  Baseline

• Subtraction - Obstacles - Dual Task Cost (%)

  persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\>145 - 138 - 131, etc.).

  Week 9 (post-measure)

• Subtraction - Obstacles - Dual Task Cost (%)

  persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.).

  week 13 (4-week follow-up)

• Vigilance - Obstacles - Dual Task Cost (%)

  persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.

  Baseline

• Vigilance - Obstacles - Dual Task Cost (%)

  persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.

  Week 9 (post-measure)

• Vigilance - Obstacles - Dual Task Cost (%)

  persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.

  week 13 (4-week follow-up)

• Digit Span - Crisscross - Dual Task Cost (%)

  persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -\> 5 4 1).

  baseline

• Digit Span - Crisscross - Dual Task Cost (%)

  persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -\> 5 4 1).

  Week 9 (post-measure)

• Digit Span - Crisscross - Dual Task Cost (%)

  persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -\> 5 4 1).

  week 13 (4-week follow-up)

• Subtraction - Crisscross - Dual Task Cost (%)

  persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.).

  Baseline

• Subtraction - Crisscross - Dual Task Cost (%)

  persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.).

  Week 9 (post-measure)

• Subtraction - Crisscross - Dual Task Cost (%)

  persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -\> 145 - 138 - 131, etc.).

  week 13 (4-week follow-up)

• Vigilance - Crisscross - Dual Task Cost (%)

  persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.

  Baseline

• Vigilance - Crisscross - Dual Task Cost (%)

  persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.

  Week 9 (post-measure)

• Vigilance - Crisscross - Dual Task Cost (%)

  persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.

  week 13 (4-week follow-up)

Secondary Outcomes (30)

• Brief Repeatable Battery of Neuropsychological Tests

  baseline

• Part of Brief Repeatable Battery of Neuropsychological Tests

  Week 9 (post-measure)

• Part of Brief Repeatable Battery of Neuropsychological Tests

  week 13 (4-week follow-up)

• Multiple Sclerosis Impact Scale-29 (MSIS-29)

  baseline

• Multiple Sclerosis Impact Scale-29 (MSIS-29)

  Week 9 (post-measure)

Study Arms (2)

Dual Task Training (DTT)

EXPERIMENTAL

Behavioral: Dual Task Training

Single Mobility Training (SMT)

ACTIVE COMPARATOR

Other: Single Mobility Training

Interventions

Dual Task Training 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

Dual Task Training (DTT)

Single Mobility Training OTHER

standard routine training

Single Mobility Training (SMT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasselt University: lead
• Revalidatie & MS Centrum Overpelt: collaborator
• National MS Center Melsbroek: collaborator
• AZ Klina: collaborator
• Centre Hospitalier Universitaire de Liege: collaborator
• Masku Neurological Rehabilitation Centre: collaborator
• Tel Aviv University: collaborator
• Sheba Medical Center: collaborator
• AISM Rehabilitation Service of Genoa: collaborator

Study Sites (1)

Revalidatie & MS Centrum Overpelt

Overpelt, 3900, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Feys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Ilse Baert, drs.

  Hasselt University

  STUDY CHAIR

• Renee Veldkamp, drs.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: knows what kind of training, but not whether the trainings-group is the control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: October 10, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

BE (1)