Multiple SclerosisNCT04142853
Underlying Causes and Related Factors, and Rehabilitation Approaches
A study testing Training intervention + Dance intervention in people with Multiple Sclerosis, run by Hasselt University at 2 sites in Belgium.
Trial summary
This study will be a cross-sectional observational study, followed by a pilot intervention. The aim of the study is to examine the underlying causes of walking-related performance fatigability, together with other related and influencing factors, to make up a clinical profile of patients with MS showing… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Training intervention + Dance intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Mar 2019to 31 Dec 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years.
- MS diagnosis according to McDonald Criteria.
- Capable of walking 6 minutes (independent or with unilateral support) without stopping.
Who cannot join
- Exacerbation or relapse within last 3 months before study
- Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, Parkinson).
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Hasselt University
Hasselt, 3500
Centre Hospitalier Universitaire de Liège
Liège, 4000
About this study
Official title: Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o
This study will be a cross-sectional observational study, followed by a pilot intervention. The aim of the study is to examine the underlying causes of walking-related performance fatigability, together with other related and influencing factors, to make up a clinical profile of patients with MS showing walking-related performance fatigability. In the second part of the study a pilot intervention will be executed to see if the investigators can improve the clinical status of the MS patients with walking-related performance fatigability.
- Conditions
- Multiple Sclerosis
- Being tested
- Training intervention + Dance intervention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training intervention + Dance interventionOther
Training intervention + Dance intervention
| Study group | Role | What they receive |
|---|---|---|
| Persons with MS, dance group | Experimental | Not described Receives: Other: Training intervention + Dance intervention |
| Persons with MS, art group | Active comparator | Not described Receives: Other: Training intervention + Dance intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Coordination test
Participant is seated with legs strapped in to the mounts and moves legs to the beat of a metronome to assess central motor control.
Measured: Day 1
TST (Triple Stimulation Technique)
Technique in which nerves are stimulated to check guidance in the central nervous system
Measured: day 3
TMS (Transcranial Magnetic Stimulation)
Technique in which nerves are stimulated to check guidance in the central nervous system
Measured: Day 3
the Voluntary Drive test
The participant is seated in a Biodex. While performing a leg extension the Quadriceps muscle is stimulated to check the guidance of electrical signals to the muscles.
Measured: Day 1
the Fatigability Index Legs
Participant is seated in a Biodex and a protocol is performed to establish the muscle strength and muscle endurance of the legs.
Measured: Day 1
Analysis of a Muscle Biopsy
A small piece of muscle tissue of the weakest leg will be biopsied and analyzed in the lab.
Measured: Day 3
the Digit Span
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Measured: Baseline
the Digit Span
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
Measured: Week 11
the Stroop test
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
Measured: Baseline
the Stroop test
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
Measured: week 11
the Paced Auditory Serial Addition Test (PASAT)
This is a cognitive test where the participant will try to retain certain numbers they hear and do math. Correct answer last 1/3 vs first 1/3
Measured: Baseline
the Paced Auditory Serial Addition Test (PASAT)
This is a cognitive test where the participant will try to retain certain numbers they hear and do math. Correct answer last 1/3 vs first 1/3
Measured: Week 11
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
Measured: Baseline
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
Measured: week 11
Motor function test (lower limb muscle strength)
This is a motor test to assess the functional lower limb muscle strength. The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row.
Measured: Baseline
Motor function test (lower limb muscle strength)
This is a motor test to assess the functional lower limb muscle strength. The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row.
Measured: week 11
25 Foot Walk (T25FW) test
his is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible. This is a quantitative performance test to assess mobility and leg function.
Measured: Baseline
25 Foot Walk (T25FW) test
his is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible. This is a quantitative performance test to assess mobility and leg function.
Measured: week 11
Nine Hole Peg Test (NHPT)
This is a motor test to assess the participant's manual skills. This test records the time the participant needs to place 9 pins in the pegboard and remove them again.
Measured: Baseline
Nine Hole Peg Test (NHPT)
This is a motor test to assess the participant's manual skills. This test records the time the participant needs to place 9 pins in the pegboard and remove them again.
Measured: week 11
Fatigability Index Hand
Grip strength will be evaluated through a Jamar dynamometer.
Measured: Baseline
Fatigability Index Hand
Grip strength will be evaluated through a Jamar dynamometer.
Measured: week 11
Activity tracker
A sensor will be placed around the foot and worn by the participant for 5 days and nights to evaluate physical activity and quality of sleep.
Measured: Up to 5 days
Glycocheck
A small camera will be placed under the tongue of the participant and blood vessels will be filmed to determine the quality of the blood vessels and immunity.
Measured: Baseline
Six minute walking test
Participant have to walk as far as they can for 6 minutes. Total distance walked and fatigability by comparing first and last minute distance will be calculated.
Measured: once during the observational study
Secondary outcomes (20)
Fatigue severity scale (FSS)
A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer
Measured: baseline
Fatigue severity scale (FSS)
A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer
Measured: week 11
Modified Fatigue Impact Scale (MFIS)
This is a short questionnaire to evaluate to impact of general fatigue. 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 is a short questionnaire to evaluate to impact of general fatigue. 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 11
Fatigue Scale of Motor and Cognitive Functions (FSMC)
This is a short questionnaire to cognitive and motor fatigue in people with MS. The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
Measured: baseline
Fatigue Scale of Motor and Cognitive Functions (FSMC)
This is a short questionnaire to cognitive and motor fatigue in people with MS. The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
Measured: week 11
Hospital Anxiety and Depression Scale (HADS)
This is a short questionnaire that evaluates symptoms of anxiety and depression in daily life. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression..
Measured: baseline
Hospital Anxiety and Depression Scale (HADS)
This is a short questionnaire that evaluates symptoms of anxiety and depression in daily life. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Measured: Week 11
The Sleep Condition Indicator (SCI)
This is a short questionnaire to evaluate sleeping pattern and potential sleeping disorders. The Sleep Condition Indicator (SCI) is an eight-item rating scale (4-0) that was developed to screen for insomnia disorder based on DSM-5 criteria.
Measured: baseline
The Sleep Condition Indicator (SCI)
This is a short questionnaire to evaluate sleeping pattern and potential sleeping disorders. The Sleep Condition Indicator (SCI) is an eight-item rating scale (4-0) that was developed to screen for insomnia disorder based on DSM-5 criteria.
Measured: week 11
Social Role Participation Questionnaire (SRPQ)
This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5(very important)
Measured: baseline
Social Role Participation Questionnaire (SRPQ)
This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5 (very important)
Measured: week 11
pre-interventionMSWS-12 score
short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.
Measured: baseline
post-interventionMSWS-12 score
short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.
Measured: baseline
pre-interventionMSWS-12 score
short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.
Measured: week 11
post-interventionMSWS-12 score
short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.
Measured: week 11
Multiple Sclerosis Impact Scale (MSIS-29)
This is a short self-report questionnaire used to assess the day-to-day life in the past two weeks. This questionnaire has a physical and psychological scale. The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health).
The physical impact score is computed by summing items number 1-20 inclusive. This score can then be transformed to a score on a scale of 0 -100
Measured: Baseline
Multiple Sclerosis Impact Scale (MSIS-29)
This is a short self-report questionnaire used to assess the day-to-day life in the past two weeks. This questionnaire has a physical and psychological scale. The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health).
The physical impact score is computed by summing items number 1-20 inclusive. This score can then be transformed to a score on a scale of 0 -100
Measured: week 11
Short Form Health survey (SF-36)
questionnaire to measure health status. The Optum® SF-36v2® Health Survey asks 36 questions to measure functional health and well-being from the patient's point of view. It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes.
Measured: Baseline
Short Form Health survey (SF-36)
questionnaire to measure health status. The Optum® SF-36v2® Health Survey asks 36 questions to measure functional health and well-being from the patient's point of view. It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes.
Measured: week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142853
- Sponsor's protocol ID
- B707201835771
- Status last verified
- May 2020
- First submitted
- 25 Oct 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goetschalckx M, Van Geel F, Meesen R, Triccas LT, Geraerts M, Moumdjian L, Feys P. Interlimb Coordination Performance in Seated Position in Persons With Multiple Sclerosis: Reduced Amplitude Over 6 min and Higher Coordination Variability in Persons With Walking Fatigability. Front Hum Neurosci. 2021 Oct 20;15:765254. doi: 10.3389/fnhum.2021.765254. eCollection 2021.
PubMed 34744669
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o
- ClinicalTrials.gov ID
- NCT04142853
- Acronym / sponsor ID
- B707201835771
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- University of Liege
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Oct 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.
This study will be a cross-sectional observational study, followed by a pilot intervention. The aim of the study is to examine the underlying causes of walking-related performance fatigability, together with other related and influencing factors, to make up a clinical profile of patients with MS showing walking-related performance fatigability. In the second part of the study a pilot intervention will be executed to see if the investigators can improve the clinical status of the MS patients with walking-related performance fatigability.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons with MS, dance group | Experimental | Other: Training intervention + Dance intervention |
| Persons with MS, art group | Active comparator | Other: Training intervention + Dance intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 70 years.
- MS diagnosis according to McDonald Criteria.
- Capable of walking 6 minutes (independent or with unilateral support) without stopping.
Key exclusion criteria (2 listed)
- Exacerbation or relapse within last 3 months before study
- Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, Parkinson).
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 |
|---|---|---|
| Training intervention + Dance interventionTraining intervention + Dance intervention | Other | Persons with MS, art group, Persons with MS, dance group |
Primary outcome
the Coordination test
Time frame: Day 1
Participant is seated with legs strapped in to the mounts and moves legs to the beat of a metronome to assess central motor control.
TST (Triple Stimulation Technique)
Time frame: day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
TMS (Transcranial Magnetic Stimulation)
Time frame: Day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
the Voluntary Drive test
Time frame: Day 1
The participant is seated in a Biodex. While performing a leg extension the Quadriceps muscle is stimulated to check the guidance of electrical signals to the muscles.
the Fatigability Index Legs
Time frame: Day 1
Participant is seated in a Biodex and a protocol is performed to establish the muscle strength and muscle endurance of the legs.
Analysis of a Muscle Biopsy
Time frame: Day 3
A small piece of muscle tissue of the weakest leg will be biopsied and analyzed in the lab.
the Digit Span
Time frame: Baseline
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
the Digit Span
Time frame: Week 11
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
the Stroop test
Time frame: Baseline
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
the Stroop test
Time frame: week 11
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
the Paced Auditory Serial Addition Test (PASAT)
Time frame: Baseline
This is a cognitive test where the participant will try to retain certain numbers they hear and do math. Correct answer last 1/3 vs first 1/3
the Paced Auditory Serial Addition Test (PASAT)
Time frame: Week 11
This is a cognitive test where the participant will try to retain certain numbers they hear and do math. Correct answer last 1/3 vs first 1/3
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
Time frame: Baseline
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
Time frame: week 11
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
Motor function test (lower limb muscle strength)
Time frame: Baseline
This is a motor test to assess the functional lower limb muscle strength. The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row.
Motor function test (lower limb muscle strength)
Time frame: week 11
This is a motor test to assess the functional lower limb muscle strength. The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row.
25 Foot Walk (T25FW) test
Time frame: Baseline
his is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible. This is a quantitative performance test to assess mobility and leg function.
25 Foot Walk (T25FW) test
Time frame: week 11
his is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible. This is a quantitative performance test to assess mobility and leg function.
Nine Hole Peg Test (NHPT)
Time frame: Baseline
This is a motor test to assess the participant's manual skills. This test records the time the participant needs to place 9 pins in the pegboard and remove them again.
Nine Hole Peg Test (NHPT)
Time frame: week 11
This is a motor test to assess the participant's manual skills. This test records the time the participant needs to place 9 pins in the pegboard and remove them again.
Fatigability Index Hand
Time frame: Baseline
Grip strength will be evaluated through a Jamar dynamometer.
Fatigability Index Hand
Time frame: week 11
Grip strength will be evaluated through a Jamar dynamometer.
Activity tracker
Time frame: Up to 5 days
A sensor will be placed around the foot and worn by the participant for 5 days and nights to evaluate physical activity and quality of sleep.
Glycocheck
Time frame: Baseline
A small camera will be placed under the tongue of the participant and blood vessels will be filmed to determine the quality of the blood vessels and immunity.
Six minute walking test
Time frame: once during the observational study
Participant have to walk as far as they can for 6 minutes. Total distance walked and fatigability by comparing first and last minute distance will be calculated.
20 secondary outcomes
Fatigue severity scale (FSS)
Time frame: baseline
Fatigue severity scale (FSS)
Time frame: week 11
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline
Modified Fatigue Impact Scale (MFIS)
Time frame: week 11
Fatigue Scale of Motor and Cognitive Functions (FSMC)
Time frame: baseline
Fatigue Scale of Motor and Cognitive Functions (FSMC)
Time frame: week 11
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 11
The Sleep Condition Indicator (SCI)
Time frame: baseline
The Sleep Condition Indicator (SCI)
Time frame: week 11
Social Role Participation Questionnaire (SRPQ)
Time frame: baseline
Social Role Participation Questionnaire (SRPQ)
Time frame: week 11
pre-interventionMSWS-12 score
Time frame: baseline
post-interventionMSWS-12 score
Time frame: baseline
pre-interventionMSWS-12 score
Time frame: week 11
post-interventionMSWS-12 score
Time frame: week 11
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: Baseline
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: week 11
Short Form Health survey (SF-36)
Time frame: Baseline
Short Form Health survey (SF-36)
Time frame: week 11
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 1 Jun 2020.
- Derived from this study: PubMed 34744669Goetschalckx M, Van Geel F, Meesen R, Triccas LT, Geraerts M, Moumdjian L, Feys P. Interlimb Coordination Performance in Seated Position in Persons With Multiple Sclerosis: Reduced Amplitude Over 6 min and Higher Coordination Variability in Persons With Walking Fatigability. Front Hum Neurosci. 2021 Oct 20;15:765254. doi: 10.3389/fnhum.2021.765254. eCollection 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training intervention + Dance intervention in people with Multiple Sclerosis, run by Hasselt University at 2 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 3 inclusion and 2 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 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
the Coordination test (time frame: Day 1). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142853, which also lists 1 linked publication.
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 1 Jun 2020.