Multiple SclerosisNCT04158063
Cognitive-motor Interference in Persons With MS
A study testing Dual Task Training and Single Mobility Training in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dual Task Training and Single Mobility Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Oct 2016to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive-motor Interference in Persons With MS: Dual Task Assessment and Training - A Multi-center Study
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.
Read more
This research consist of two parts that aim to investigate:
Part 1: Assessment
- the magnitude of the dual task cost according to different types of cognitive distractors (information processing, memory, attention, etc.),
- its reliability as experimental outcome measure and
- its association with factors as severity of cognitive or motor dysfunction, quality of life and fatigue.
Part 2: Intervention
- the effectiveness of cognitive-motor DT-based training programs compared to single modality training, on DT and ST performances (cognition and mobility)
- whether dual task learning effects transfer to improvements in daily life and are sustained for 4 weeks without training
- which patient profiles benefit most from the integrated cognitive-motor training
- feasibility and usefulness of an adaptive, interactive ICT-guided DTT system.
- Conditions
- Multiple Sclerosis
- Being tested
- Dual Task Training, Single Mobility Training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Task TrainingBehavioural
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 TrainingOther
standard routine training
| Study group | Role | What they receive |
|---|---|---|
| Dual Task Training (DTT) | Experimental | Not described Receives: Behavioral: Dual Task Training |
| Single Mobility Training (SMT) | Active comparator | Not described Receives: Other: Single Mobility Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.).
Measured: 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.).
Measured: 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.).
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.).
Measured: 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.).
Measured: 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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.).
Measured: 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.).
Measured: 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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 13 (4-week follow-up)
Secondary outcomes (30)
Brief Repeatable Battery of Neuropsychological Tests
This battery consists of six tests in different cognitive domains: 1) the Selective Reminding test, 2) the 10/36 spatial recall test, 3) the symbol digit modalities test, 4) the Paced auditory serial addition test with 3 seconds, 5) the Paced auditory serial addition test with 2 seconds and 6) the word list generation.
Measured: baseline
Part of Brief Repeatable Battery of Neuropsychological Tests
The symbol digit modalities test, the Paced auditory serial addition test with 3 seconds and the Paced auditory serial addition test with 2 seconds were assessed.
Measured: Week 9 (post-measure)
Part of Brief Repeatable Battery of Neuropsychological Tests
The symbol digit modalities test, the Paced auditory serial addition test with 3 seconds and the Paced auditory serial addition test with 2 seconds were assessed.
Measured: week 13 (4-week follow-up)
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Questionnaire to record participants' perceived impact of MS on day-to-day life.
a 29-item self-report measure comprised of 20 items associated with a physical scale and 9 items associated with a psychological scale.1 Items question patients (or their proxies) about the impact of multiple sclerosis (MS) on day-today life in the last 2 weeks. All items have 5 response options from 1 (not at all) to 5 (extremely). Each of the 2 scales are scored by summing the responses across items, then converting to a 0 to 100 scale, where 100 indicates greater impact of disease on daily function (worse health).
Measured: baseline
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Questionnaire to record participants' perceived impact of MS on day-to-day life.
a 29-item self-report measure comprised of 20 items associated with a physical scale and 9 items associated with a psychological scale.1 Items question patients (or their proxies) about the impact of multiple sclerosis (MS) on day-today life in the last 2 weeks. All items have 5 response options from 1 (not at all) to 5 (extremely). Each of the 2 scales are scored by summing the responses across items, then converting to a 0 to 100 scale, where 100 indicates greater impact of disease on daily function (worse health).
Measured: Week 9 (post-measure)
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Questionnaire to record participants' perceived impact of MS on day-to-day life.
a 29-item self-report measure comprised of 20 items associated with a physical scale and 9 items associated with a psychological scale.1 Items question patients (or their proxies) about the impact of multiple sclerosis (MS) on day-today life in the last 2 weeks. All items have 5 response options from 1 (not at all) to 5 (extremely). Each of the 2 scales are scored by summing the responses across items, then converting to a 0 to 100 scale, where 100 indicates greater impact of disease on daily function (worse health).
Measured: week 13 (4-week follow-up)
Modified Fatigue Impact Scale (MFIS)
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
Measured: baseline
Modified Fatigue Impact Scale (MFIS)
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
Measured: Week 9 (post-measure)
Modified Fatigue Impact Scale (MFIS)
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
Measured: week 13 (4-week follow-up)
Dual Task Questionnaire
Questionnaire to record participants' perception of dual task problems in daily life.
Measured: Baseline
Dual Task Questionnaire
Questionnaire to record participants' perception of dual task problems in daily life.
Measured: Week 9 (post-measure)
Dual Task Questionnaire
Questionnaire to record participants' perception of dual task problems in daily life.
Measured: week 13 (4-week follow-up)
Timed 25 Foot-walk test (T25FW)
test of motor function in which participants walk 25-foot.
Measured: baseline
Timed 25 Foot-walk test (T25FW)
test of motor function in which participants walk 25-foot.
Measured: Week 9 (post-measure)
Timed 25 Foot-walk test (T25FW)
test of motor function in which participants walk 25-foot.
Measured: week 13 (4-week follow-up)
Timed-up-and-go test (TUG)
test of walking and balance in which participants stand up from a chair, walk, turn and sit down again.
Measured: baseline
Timed-up-and-go test (TUG)
test of walking and balance in which participants stand up from a chair, walk, turn and sit down again.
Measured: Week 9 (post-measure)
Timed-up-and-go test (TUG)
test of walking and balance in which participants stand up from a chair, walk, turn and sit down again.
Measured: week 13 (4-week follow-up)
Dynamic Gait Index (DGI)
test in which assessor scores gait performance of the participant.
Measured: Baseline
Dynamic Gait Index (DGI)
test in which assessor scores gait performance of the participant.
Measured: Week 9 (post-measure)
Dynamic Gait Index (DGI)
test in which assessor scores gait performance of the participant.
Measured: week 13 (4-week follow-up)
2-minute walking test (2MWT)
test of walking in which participants walk for 2 minutes
Measured: baseline
2-minute walking test (2MWT)
test of walking in which participants walk for 2 minutes
Measured: Week 9 (post-measure)
2-minute walking test (2MWT)
test of walking in which participants walk for 2 minutes
Measured: week 13 (4-week follow-up)
Multiple sclerosis walking scale-12 (MSWS-12)
questionnaire to measure perception of limitations in walking ability caused by MS.
Measured: baseline
Multiple sclerosis walking scale-12 (MSWS-12)
questionnaire to measure perception of limitations in walking ability caused by MS.
Measured: Week 9 (post-measure)
Multiple sclerosis walking scale-12 (MSWS-12)
questionnaire to measure perception of limitations in walking ability caused by MS.
Measured: week 13 (4-week follow-up)
Falls efficacy scale (FES-I)
uestionnaire to measure concerns about the possibility of falling.
Measured: baseline
Falls efficacy scale (FES-I)
uestionnaire to measure concerns about the possibility of falling.
Measured: Week 9 (post-measure)
Falls efficacy scale (FES-I)
uestionnaire to measure concerns about the possibility of falling.
Measured: week 13 (4-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start10 Oct 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek, AZ Klina, Centre Hospitalier Universitaire de Liege, Masku Neurological Rehabilitation Centre, Tel Aviv University, Sheba Medical Center, AISM Rehabilitation Service of Genoa
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feys, prof. dr., Principal investigator, Hasselt UniversityIlse Baert, drs., Study chair, Hasselt UniversityRenee Veldkamp, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158063
- Sponsor's protocol ID
- MCS-IV-CMI&DTT-01
- Status last verified
- Nov 2019
- First submitted
- 6 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-motor Interference in Persons With MS: Dual Task Assessment and Training - A Multi-center Study
- ClinicalTrials.gov ID
- NCT04158063
- Acronym / sponsor ID
- MCS-IV-CMI&DTT-01
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek, AZ Klina, Centre Hospitalier Universitaire de Liege, Masku Neurological Rehabilitation Centre, Tel Aviv University, Sheba Medical Center, AISM Rehabilitation Service of Genoa
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- the magnitude of the dual task cost according to different types of cognitive distractors (information processing, memory, attention, etc.),
- its reliability as experimental outcome measure and
- its association with factors as severity of cognitive or motor dysfunction, quality of life and fatigue.
Part 2: Intervention
- the effectiveness of cognitive-motor DT-based training programs compared to single modality training, on DT and ST performances (cognition and mobility)
- whether dual task learning effects transfer to improvements in daily life and are sustained for 4 weeks without training
- which patient profiles benefit most from the integrated cognitive-motor training
- feasibility and usefulness of an adaptive, interactive ICT-guided DTT system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Task Training (DTT) | Experimental | Behavioral: Dual Task Training |
| Single Mobility Training (SMT) | Active comparator | Other: Single Mobility Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Task TrainingIn 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 | Behavioural | Dual Task Training (DTT) |
| Single Mobility Trainingstandard routine training | Other | Single Mobility Training (SMT) |
Primary outcome
Digit Span - Walk - Dual Task Cost (%)
Time frame: Baseline
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
Digit Span - Walk - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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
Digit Span - Walk - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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
Subtraction - Walk - Dual Task Cost (%)
Time frame: Baseline
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.)
Subtraction - Walk - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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.)
Subtraction - Walk - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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.)
Vigilance - Walk - Dual Task Cost (%)
Time frame: Baseline
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.
Vigilance - Walk - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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.
Vigilance - Walk - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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.
Digit Span - Cup - Dual Task Cost (%)
Time frame: Baseline
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).
Digit Span - Cup - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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).
Digit Span - Cup - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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).
Subtraction - Cup - Dual Task Cost (%)
Time frame: Baseline
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.).
Subtraction - Cup - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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.).
Subtraction - Cup - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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.).
Vigilance - Cup - Dual Task Cost (%)
Time frame: baseline
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
Vigilance - Cup - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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
Vigilance - Cup - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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
Digit Span - Obstacles - Dual Task Cost (%)
Time frame: Baseline
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).
Digit Span - Obstacles - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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).
Digit Span - Obstacles - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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).
Subtraction - Obstacles - Dual Task Cost (%)
Time frame: Baseline
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.).
Subtraction - Obstacles - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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.).
Subtraction - Obstacles - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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.).
Vigilance - Obstacles - Dual Task Cost (%)
Time frame: Baseline
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.
Vigilance - Obstacles - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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.
Vigilance - Obstacles - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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.
Digit Span - Crisscross - Dual Task Cost (%)
Time frame: baseline
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).
Digit Span - Crisscross - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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).
Digit Span - Crisscross - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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).
Subtraction - Crisscross - Dual Task Cost (%)
Time frame: Baseline
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.).
Subtraction - Crisscross - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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.).
Subtraction - Crisscross - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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.).
Vigilance - Crisscross - Dual Task Cost (%)
Time frame: Baseline
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.
Vigilance - Crisscross - Dual Task Cost (%)
Time frame: Week 9 (post-measure)
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.
Vigilance - Crisscross - Dual Task Cost (%)
Time frame: week 13 (4-week follow-up)
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.
30 secondary outcomes
Brief Repeatable Battery of Neuropsychological Tests
Time frame: baseline
Part of Brief Repeatable Battery of Neuropsychological Tests
Time frame: Week 9 (post-measure)
Part of Brief Repeatable Battery of Neuropsychological Tests
Time frame: week 13 (4-week follow-up)
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: baseline
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: Week 9 (post-measure)
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: week 13 (4-week follow-up)
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline
Modified Fatigue Impact Scale (MFIS)
Time frame: Week 9 (post-measure)
Modified Fatigue Impact Scale (MFIS)
Time frame: week 13 (4-week follow-up)
Dual Task Questionnaire
Time frame: Baseline
Dual Task Questionnaire
Time frame: Week 9 (post-measure)
Dual Task Questionnaire
Time frame: week 13 (4-week follow-up)
Timed 25 Foot-walk test (T25FW)
Time frame: baseline
Timed 25 Foot-walk test (T25FW)
Time frame: Week 9 (post-measure)
Timed 25 Foot-walk test (T25FW)
Time frame: week 13 (4-week follow-up)
Timed-up-and-go test (TUG)
Time frame: baseline
Timed-up-and-go test (TUG)
Time frame: Week 9 (post-measure)
Timed-up-and-go test (TUG)
Time frame: week 13 (4-week follow-up)
Dynamic Gait Index (DGI)
Time frame: Baseline
Dynamic Gait Index (DGI)
Time frame: Week 9 (post-measure)
Dynamic Gait Index (DGI)
Time frame: week 13 (4-week follow-up)
2-minute walking test (2MWT)
Time frame: baseline
2-minute walking test (2MWT)
Time frame: Week 9 (post-measure)
2-minute walking test (2MWT)
Time frame: week 13 (4-week follow-up)
Multiple sclerosis walking scale-12 (MSWS-12)
Time frame: baseline
Multiple sclerosis walking scale-12 (MSWS-12)
Time frame: Week 9 (post-measure)
Multiple sclerosis walking scale-12 (MSWS-12)
Time frame: week 13 (4-week follow-up)
Falls efficacy scale (FES-I)
Time frame: baseline
Falls efficacy scale (FES-I)
Time frame: Week 9 (post-measure)
Falls efficacy scale (FES-I)
Time frame: week 13 (4-week follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Feys, prof. dr. principal investigator
Hasselt University
Ilse Baert, drs. study chair
Hasselt University
Renee Veldkamp, drs. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Task Training and Single Mobility Training in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digit Span - Walk - Dual Task Cost (%) (time frame: Baseline). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.