Multiple SclerosisNCT06028776
Effects of MS Ballroom Fitness on Balance, Walking Capacity, and Well-being in Multiple Sclerosis
A study testing MS Ballroom Fitness in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of the present study is to evaluate the effects of a dance-based concept entitled MS Ballroom Fitness (developed in Denmark by PT Elisabeth Dalsgaard) in persons with multiple sclerosis (pwMS). A total of 88 pwMS will be enrolled and equally randomized into an intervention group or a control-waitlist group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MS Ballroom Fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2023to 10 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-reported MS diagnosis
- patient-determined disease steps (PDDS) ≤ 7 (7 correspond to use a wheelchair for most daily activities)
- able to independently attend the testing
Who cannot join
- self-reported comorbidities excluding participation in the intervention
- substantial cognitive impairments hindering participation
- recent fractures (6 months)
- critical physical impairments hindering participation in the described training study
- participation in structured exercise therapy (including dancing) for the past 3 months (≥ 2 session per week of moderate-to-high intensity)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MS Ballroom Fitness - Benefits of a Personalized Dance-based Concept on Balance, Walking Capacity, and Well-being in Multiple Sclerosis
The goal of the present study is to evaluate the effects of a dance-based concept entitled MS Ballroom Fitness (developed in Denmark by PT Elisabeth Dalsgaard) in persons with multiple sclerosis (pwMS). A total of 88 pwMS will be enrolled and equally randomized into an intervention group or a control-waitlist group. Those in the intervention group will undertake 7 weeks of MS Ballroom Fitness, with 2 sessions per week.
The investigators assume that balance, walking capacity as well as well-being will be improved.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system (CNS) causing demyelination of axons within the CNS as well as loss of axons and neurons. While a wide range of symptoms potentially develops due to the pathology of MS, lower extremity motor function appears preferentially affected. It is therefore not surprising that substantial impairments in balance and walking capacity have been reported in pwMS, based on both subjective (patient perspectives) and objective assessments. This is problematic as balance and walking capacity are rated among the most important bodily functions, and furthermore associated with mental well-being and quality of life.
In pwMS, walking balance/coordination can be assessed by the six spot step test (SSST). Dynamic balance/coordination can be assessed by the four sqaure step test (FSST). Balance can also be assessed by the functional reach test (FRT) as well as the 30-second single leg stance test. Other measures of walking capacity can be assessed by a 'simple' short distance walk test (e.g., the timed 25 foot maximal walk test (T25FWT)) and a long distance 'endurance' walk test (e.g., the 6-minute maximal walk test (6MWT)). In addition to these, the 12-item MS Walking Scale (MSWS-12) are commonly used to assess the patient-reported impact of MS on different aspects of walking ability.
Different modalities of exercise therapy have been shown effective in counteracting the deterioration of balance and walking capacity observed in pwMS, with improvements reported across all the tests outlined above. Interestingly, dance (including mixed modalities with a predominant dance-based content) appear particularly potent in terms of targeting impairments in balance AND walking capacity. Whilst some pilot/exploratory studies involving pwMS exist, the summarized evidence appear sparse and contain three major limitations. First, the majority of pwMS studies are small exploratory non-controlled studies lacking sample size calculations. Second, none of the identified dance studies provide a personalized approach, i.e., by designing interventions that embrace the needs and physical functional level of each participant. Third, none of the identified dance studies have assessed whether dance-induced adaptations in balance and walking capacity are accompanied by - or even translates into - improvements in mental well-being and quality of life.
Physiotherapist Elisabeth Dalsgaard has developed a dance-based concept entitled MS Ballroom FitnessTM (abbreviated MSB-Fit) with a specific focus on joy of life and inclusion. It is specifically adapted to pwMS, having three difficulty levels that correspond to three overall disability categories (sitting, standing, and walking pwMS).
The study sample size was calculated based on unpublished SSST pilot data from n=11 pwMS undergoing 7 weeks of MSB-Fit, corresponding to what was offered in the present study. The estimate (α = 0.05; power = 0.90; control mean post intervention 7.16±1.18 s; MSB-Fit mean post intervention 6.27±1.18 s; dropout rate = 15%) suggested that a total of n=88 pwMS should be enrolled in the present study.
- Conditions
- Multiple Sclerosis
- Being tested
- MS Ballroom Fitness
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS Ballroom FitnessBehavioural
A personalized dance-based concept focusing on balance, walking capacity, and well-being.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group will be offered 2 weekly sessions (45-60 min) of MS Ballroom Fitness for a period of 7 weeks. All other 'usual care' are allowed. Receives: Behavioral: MS Ballroom Fitness |
| Control | No intervention | This group will continue their habitual living, also including whatever 'usual care' they participate in. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six spot step test (SSST)
Objective test that measures walking coordination and balance. Unit: seconds.
Measured: Change from Baseline to 7 weeks
WHO5 wellbeing index
Questionnaire that measures current mental well-being. Unit: score (0-100; 100 is better).
Measured: Change from Baseline to 7 weeks
Secondary outcomes (12)
Static balance
Objective test that measures static balance (total score based on 2 different tests; 20s right leg foot stand, 20s left leg foot stand). Unit: seconds (0-40s; 40s is better)
Measured: Change from Baseline to 7 weeks
Functional reach test
Objective test that measures how far a person can reach with one arm in standing position. Unit: cm.
Measured: Change from Baseline to 7 weeks
Modified functional reach test
Objective test that measures how far a person can reach (forward, left, right) with one arm in sitting position. Unit: cm.
NB: This test is used for wheel-chair users only.
Measured: Change from Baseline to 7 weeks
Four square step test (FSST)
Objective test that measures dynamic stability and co-ordination. Unit: s.
Measured: Change from Baseline to 7 weeks
6-minute walk test
Objective test that measures walking endurance. Unit: meters.
Measured: Change from Baseline to 7 weeks
Trunk Impairment Scale 2.0
Rater-evaluated test that measures static and dynamic sitting balance as well as co-ordination of trunk movement. Unit: score (0-23; 23 is better).
NB: This test is used for wheel-chair users only.
Measured: Change from Baseline to 7 weeks
Patient determined disease steps
Questionnaire that measures level of disability in multiple sclerosis. Unit: score (0-8; 0 is better).
Measured: Change from Baseline to 7 weeks
Multiple Sclerosis Walking Scale
Questionnaire that measures walking limitations in multiple sclerosis. Unit: score (0-100; 0 is better).
Measured: Change from Baseline to 7 weeks
Health-related quality of life visual analogue scale (HR-QoL VAS)
Questionnaire/scale that measures quality of life. Unit: score (0-100; 0 is better).
Measured: Change from Baseline to 7 weeks
Modified fatigue impact scale
Questionnaire that measures the impact fatigue has on daily life. Unit: score (0-84; 0 is better)
Measured: Change from Baseline to 7 weeks
Falls-efficacy scale - international
Questionnaire that measures concerns about falling. Unit: score (16-64; 16 is better)
Measured: Change from Baseline to 7 weeks
Falls
Number of falls in the past year
Measured: Change from Baseline to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2024
- Study completion10 Sep 2024
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Model description
- The investigators will use a classic RCT approach, although participants randomized into the control group will be offered the intervention afterwards (hence, termed control-waitlist group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish MS Society
- Responsible party
- Sponsor
- Investigators
- Lars Hvid, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028776
- Sponsor's protocol ID
- MS_Ballroom_Fit
- Status last verified
- Dec 2024
- First submitted
- 31 Aug 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: By Danish Law and following GPDR regulations from Aarhus University, we are not allowed to share individual data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MS Ballroom Fitness - Benefits of a Personalized Dance-based Concept on Balance, Walking Capacity, and Well-being in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06028776
- Acronym / sponsor ID
- MS_Ballroom_Fit
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish MS Society
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 8 Sep 2023 (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.
The goal of the present study is to evaluate the effects of a dance-based concept entitled MS Ballroom Fitness (developed in Denmark by PT Elisabeth Dalsgaard) in persons with multiple sclerosis (pwMS). A total of 88 pwMS will be enrolled and equally randomized into an intervention group or a control-waitlist group. Those in the intervention group will undertake 7 weeks of MS Ballroom Fitness, with 2 sessions per week.
The investigators assume that balance, walking capacity as well as well-being will be improved.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system (CNS) causing demyelination of axons within the CNS as well as loss of axons and neurons. While a wide range of symptoms potentially develops due to the pathology of MS, lower extremity motor function appears preferentially affected. It is therefore not surprising that substantial impairments in balance and walking capacity have been reported in pwMS, based on both subjective (patient perspectives) and objective assessments. This is problematic as balance and walking capacity are rated among the most important bodily functions, and furthermore associated with mental well-being and quality of life.
In pwMS, walking balance/coordination can be assessed by the six spot step test (SSST). Dynamic balance/coordination can be assessed by the four sqaure step test (FSST). Balance can also be assessed by the functional reach test (FRT) as well as the 30-second single leg stance test. Other measures of walking capacity can be assessed by a 'simple' short distance walk test (e.g., the timed 25 foot maximal walk test (T25FWT)) and a long distance 'endurance' walk test (e.g., the 6-minute maximal walk test (6MWT)). In addition to these, the 12-item MS Walking Scale (MSWS-12) are commonly used to assess the patient-reported impact of MS on different aspects of walking ability.
Different modalities of exercise therapy have been shown effective in counteracting the deterioration of balance and walking capacity observed in pwMS, with improvements reported across all the tests outlined above. Interestingly, dance (including mixed modalities with a predominant dance-based content) appear particularly potent in terms of targeting impairments in balance AND walking capacity. Whilst some pilot/exploratory studies involving pwMS exist, the summarized evidence appear sparse and contain three major limitations. First, the majority of pwMS studies are small exploratory non-controlled studies lacking sample size calculations. Second, none of the identified dance studies provide a personalized approach, i.e., by designing interventions that embrace the needs and physical functional level of each participant. Third, none of the identified dance studies have assessed whether dance-induced adaptations in balance and walking capacity are accompanied by - or even translates into - improvements in mental well-being and quality of life.
Physiotherapist Elisabeth Dalsgaard has developed a dance-based concept entitled MS Ballroom FitnessTM (abbreviated MSB-Fit) with a specific focus on joy of life and inclusion. It is specifically adapted to pwMS, having three difficulty levels that correspond to three overall disability categories (sitting, standing, and walking pwMS).
The study sample size was calculated based on unpublished SSST pilot data from n=11 pwMS undergoing 7 weeks of MSB-Fit, corresponding to what was offered in the present study. The estimate (α = 0.05; power = 0.90; control mean post intervention 7.16±1.18 s; MSB-Fit mean post intervention 6.27±1.18 s; dropout rate = 15%) suggested that a total of n=88 pwMS should be enrolled in the present study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will use a classic RCT approach, although participants randomized into the control group will be offered the intervention afterwards (hence, termed control-waitlist group).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MS Ballroom FitnessThis group will be offered 2 weekly sessions (45-60 min) of MS Ballroom Fitness for a period of 7 weeks. All other 'usual care' are allowed. |
| Control | No intervention | –This group will continue their habitual living, also including whatever 'usual care' they participate in. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- self-reported MS diagnosis
- patient-determined disease steps (PDDS) ≤ 7 (7 correspond to use a wheelchair for most daily activities)
- able to independently attend the testing
Key exclusion criteria (5 listed)
- self-reported comorbidities excluding participation in the intervention
- substantial cognitive impairments hindering participation
- recent fractures (6 months)
- critical physical impairments hindering participation in the described training study
- participation in structured exercise therapy (including dancing) for the past 3 months (≥ 2 session per week of moderate-to-high intensity)
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 |
|---|---|---|
| MS Ballroom FitnessA personalized dance-based concept focusing on balance, walking capacity, and well-being. | Behavioural | Intervention |
Primary outcome
Six spot step test (SSST)
Time frame: Change from Baseline to 7 weeks
Objective test that measures walking coordination and balance. Unit: seconds.
WHO5 wellbeing index
Time frame: Change from Baseline to 7 weeks
Questionnaire that measures current mental well-being. Unit: score (0-100; 100 is better).
12 secondary outcomes
Static balance
Time frame: Change from Baseline to 7 weeks
Functional reach test
Time frame: Change from Baseline to 7 weeks
Modified functional reach test
Time frame: Change from Baseline to 7 weeks
Four square step test (FSST)
Time frame: Change from Baseline to 7 weeks
6-minute walk test
Time frame: Change from Baseline to 7 weeks
Trunk Impairment Scale 2.0
Time frame: Change from Baseline to 7 weeks
Patient determined disease steps
Time frame: Change from Baseline to 7 weeks
Multiple Sclerosis Walking Scale
Time frame: Change from Baseline to 7 weeks
Health-related quality of life visual analogue scale (HR-QoL VAS)
Time frame: Change from Baseline to 7 weeks
Modified fatigue impact scale
Time frame: Change from Baseline to 7 weeks
Falls-efficacy scale - international
Time frame: Change from Baseline to 7 weeks
Falls
Time frame: Change from Baseline to 7 weeks
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 19 Mar 2025.
- Individual participant dataSharing planned: No. By Danish Law and following GPDR regulations from Aarhus University, we are not allowed to share individual data.
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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.
Lars Hvid, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS Ballroom Fitness in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
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 5 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 19 Mar 2025. 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 Denmark. 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?
Six spot step test (SSST) (time frame: Change from Baseline to 7 weeks). The study lists 2 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 19 Mar 2025.