Multiple SclerosisDTCNCT02493166
Dual Task Cost in the Upper Limb in Persons With Multiple Sclerosis
A study testing dual task cost (cognitive-motor interference) in people with Multiple Sclerosis, run by Hasselt University at 4 sites in Belgium.
Trial summary
Multiple sclerosis (MS) is a chronic, inflammatory, neurodegenerative disorder of the central nervous system, with more than 2.5 million people in the world. It is the most non-traumatic cause of disability in young and middle-aged adults. Because the lesions are spread in the brains, there is a variety of symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- dual task cost (cognitive-motor interference)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesBelgium
- Study dates
- Mar 2016to Jun 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of MS according to McDonald's criteria
- 18+
- Have no other neurological or orthopedic disorder of the upper limb or spine. They should have the possibility to actively participate in the research.
- Nine hole peg test, in which the cut-off value is set at 0.5 PEG / sec
Who cannot join
- Patients are excluded with serious psychological problems.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
AZ Klina
Brasschaat, 2930
Private practice physician De Barsy
Brasschaat, 2930
Hasselt University
Diepenbeek, 3560
UZ Antwerp
Edegem, 2650
About this study
Official title: Cognitive Motor Interference During Dual Tasking With Movements of the Upper Limb in Persons With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory, neurodegenerative disorder of the central nervous system, with more than 2.5 million people in the world. It is the most non-traumatic cause of disability in young and middle-aged adults.
Because the lesions are spread in the brains, there is a variety of symptoms. The most common symptom is the typical motor dysfunction. 66% of persons with MS, and even 81% of them after 15 years, have problems with movements in one or both upper extremities.
Read more
Also, 40 untill 70% of persons with Multiple Sclerosis have cognitive impairment. Although they are less visible, they can have a major determining influence on social or work-related domains. The most frequent cognitive dysfunctions are sustained attention, reduced speed of information processing, impaired memory and limited executive functions.
When a combination, of motor and cognitive task, is asked, the execution of these tasks could be difficult with the foregoing in mind. For example problems during chatting while cooking, typing a report at a meeting or watching television while ironing.
The dual-task paradigm assumes that the attention should be divided between two simultaneous tasks. A dual task cost (DTC) is a restriction in performance on each task, compared whit the separate task versus simultaneously.
Research on dual tasking with persons with MS has already studied extensively, but not specific on the upper limb. In 2015 Learmonth, Pilutti and Motl published an primary research on the DTC. They combined the movements of the upper limb with a cognitive task. The research showed a difference between Persons with MS and the control group. At methodological level, there is lacking on the randomization of tasks. That is an important bias because of the learning effect of the tasks. They used only one task for the upper limb; this isn't enough to generalize the concept of motor interference in Persons with MS.
The study has two research questions:
- Have Persons with MS a greater DTC compared with a healthy control group? The motor task is executed with the upper limb.
- Is there a difference on DTC in persons with MS depending on the motor task?
This research is an observational case-control study in which individuals with MS will be compared to a healthy control group. They will be two moments of assessments. On the first day the general performance of the persons will be measured, by using clinical evaluation tests and questionnaires. On the second day they will be tests on the dual tasks, specific a comparison between single versus simultaneously performed tasks.
- Conditions
- Multiple Sclerosis
- Being tested
- dual task cost (cognitive-motor interference)
- 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 cost (cognitive-motor interference)Other
comparing single versus dual task performance (on both motor and cognitive task)
| Study group | Role | What they receive |
|---|---|---|
| patients with Multiple sclerosis Dual task cost | Active comparator | Dual task cost (cognitive-motor interference), comparing single versus dual task performance (on both motor and cognitive task) Receives: Other: dual task cost (cognitive-motor interference) |
| Healthy volontiers Dual task cost | Active comparator | Dual task cost (cognitive-motor interference), comparing single versus dual task performance (on both motor and cognitive task) Receives: Other: dual task cost (cognitive-motor interference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
single motor task cost
comparing single versus dual task performance on motor task
Measured: day 1
Dual motor task cost
Comparing single versus dual task performance on congnitive task
Measured: day 2
single cognitive task cost
Comparing single versus dual task performance on congnitive task
Measured: day 1
Dual cognitive task cost
Comparing single versus dual task performance on congnitive task
Measured: day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2016
- Study completionJun 2016
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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Klina, University Hospital, Antwerp, private practice physician De Barsy
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feys, prof. dr., Principal investigator, Hasselt UniversityJoke Raats, Study chair, AZ Klina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493166
- Sponsor's protocol ID
- 2015-PFE-JRA01
- Acronym
- DTC
- Status last verified
- Jun 2016
- First submitted
- 2 Jul 2015
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Motor Interference During Dual Tasking With Movements of the Upper Limb in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02493166
- Acronym / sponsor ID
- DTC / 2015-PFE-JRA01
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- AZ Klina, University Hospital, Antwerp, private practice physician De Barsy
- Study start
- Mar 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Jul 2015 (estimated)
- 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.
Multiple sclerosis (MS) is a chronic, inflammatory, neurodegenerative disorder of the central nervous system, with more than 2.5 million people in the world. It is the most non-traumatic cause of disability in young and middle-aged adults.
Because the lesions are spread in the brains, there is a variety of symptoms. The most common symptom is the typical motor dysfunction. 66% of persons with MS, and even 81% of them after 15 years, have problems with movements in one or both upper extremities.
Also, 40 untill 70% of persons with Multiple Sclerosis have cognitive impairment. Although they are less visible, they can have a major determining influence on social or work-related domains. The most frequent cognitive dysfunctions are sustained attention, reduced speed of information processing, impaired memory and limited executive functions.
When a combination, of motor and cognitive task, is asked, the execution of these tasks could be difficult with the foregoing in mind. For example problems during chatting while cooking, typing a report at a meeting or watching television while ironing.
The dual-task paradigm assumes that the attention should be divided between two simultaneous tasks. A dual task cost (DTC) is a restriction in performance on each task, compared whit the separate task versus simultaneously.
Research on dual tasking with persons with MS has already studied extensively, but not specific on the upper limb. In 2015 Learmonth, Pilutti and Motl published an primary research on the DTC. They combined the movements of the upper limb with a cognitive task. The research showed a difference between Persons with MS and the control group. At methodological level, there is lacking on the randomization of tasks. That is an important bias because of the learning effect of the tasks. They used only one task for the upper limb; this isn't enough to generalize the concept of motor interference in Persons with MS.
The study has two research questions:
- Have Persons with MS a greater DTC compared with a healthy control group? The motor task is executed with the upper limb.
- Is there a difference on DTC in persons with MS depending on the motor task?
This research is an observational case-control study in which individuals with MS will be compared to a healthy control group. They will be two moments of assessments. On the first day the general performance of the persons will be measured, by using clinical evaluation tests and questionnaires. On the second day they will be tests on the dual tasks, specific a comparison between single versus simultaneously performed tasks.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with Multiple sclerosis Dual task cost | Active comparator | Other: dual task cost (cognitive-motor interference)Dual task cost (cognitive-motor interference), comparing single versus dual task performance (on both motor and cognitive task) |
| Healthy volontiers Dual task cost | Active comparator | Other: dual task cost (cognitive-motor interference)Dual task cost (cognitive-motor interference), comparing single versus dual task performance (on both motor and cognitive task) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of MS according to McDonald's criteria
- 18+
- Have no other neurological or orthopedic disorder of the upper limb or spine. They should have the possibility to actively participate in the research.
- Nine hole peg test, in which the cut-off value is set at 0.5 PEG / sec
Key exclusion criteria (1 listed)
- Patients are excluded with serious psychological problems.
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 cost (cognitive-motor interference)comparing single versus dual task performance (on both motor and cognitive task) | Other | Healthy volontiers Dual task cost, patients with Multiple sclerosis Dual task cost |
Primary outcome
single motor task cost
Time frame: day 1
comparing single versus dual task performance on motor task
Dual motor task cost
Time frame: day 2
Comparing single versus dual task performance on congnitive task
single cognitive task cost
Time frame: day 1
Comparing single versus dual task performance on congnitive task
Dual cognitive task cost
Time frame: day 2
Comparing single versus dual task performance on congnitive task
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 14 Jun 2016.
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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
Joke Raats study chair
AZ Klina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual task cost (cognitive-motor interference) in people with Multiple Sclerosis, run by Hasselt University at 4 sites 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 4 inclusion and 1 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 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
single motor task cost (time frame: day 1). The study lists 4 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 14 Jun 2016.