Multiple SclerosisBALANCE-MSNCT07805850
Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis
A study testing Balance training and Sporttherapy in people with Multiple Sclerosis and Balance, run by Klinik Valens at 1 site in Switzerland.
Trial summary
Balance training is recommended to improve gait stability and mobility. However, there are currently no clearly defined methods for controlling the intensity (challenge) of balance training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Balance
- What is being tested?
- Balance training and Sporttherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with a definite MS diagnosis according to 2024 revised McDonald criteria;
- Hold an Expanded disability status (EDSS) between 2.0-6.5;
- An inpatient stay of at least three weeks at the ;
- Aged 18 years and older;
- Have sufficient knowledge of the German language (spoken and written).
Who cannot join
- Cognitive impairment indicated by a score of <21 on the Montreal Cognitive Assessment (MoCA);
- Severe osteoporosis;
- Fractures and/or other surgical interventions;
- Presence of any other condition that would substantially influence balance;
- Alcoholism;
- Participation in another study;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Rehabilitation Centre Valens
Valens, Canton of St. Gallen, 7317
Jens Bansi, PhD, +41 58 511 13 02, jens.bansi@kliniken-valens.ch
Isa Slotboom, MSc, +41 58 511 13 02, isa.slotboom@kliniken-valens.ch
About this study
Official title: Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis - a Randomized Feasibility Study
Balance training is recommended to improve gait stability and mobility. However, there are currently no clearly defined methods for controlling the intensity (challenge) of balance training. This research project aims to determine whether balance training for individuals with multiple sclerosis (MS), individually tailored to the level of difficulty and exertion, is feasible and possible within an inpatient rehabilitation setting. Participants will be randomly assigned to one of two groups: either they will complete group training focusing on strength, endurance, and balance in addition to their regular therapy program, or they will receive individually tailored balance training. Both groups will undergo an initial assessment followed by seven training sessions, each lasting approximately 45-60 minutes. Before discharge, the initial assessments will be repeated. These assessments include completing questionnaires, performing gait tests, balance tests, and a short cognitive test. Interviews will also be conducted with patients and therapists. These are intended to help better assess the feasibility of the training and to gain more insight into the experiences with the training.
- Conditions
- Multiple Sclerosis, Balance
- Being tested
- Balance training, Sporttherapy
- Keywords
- Balance, Postural Control, Intensity, Multiple Sclerosis, Walking, Gait, 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.
Balance trainingOther
The balance training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes. The intervention is designed to meet the individual needs of pwMS and allows for challenging tasks, while guaranteeing safety by a harnass. During the first training session the appropriate exercise levels that target the adequate intensity are determined (baseline value). Moderate to high-intensive BT in this study is defined as a score of 7-9 points on the rate of perceived stability (RPS) scale and to fulfill the moderate to high-intensive characteristics on the therapists' scale. The intensity of each exercise (level of challenge during the exercise) is monitored and documented for both the therapists and pwMS. According to this feedback, progression is performed by systematically by in- or decreasing difficulty of the exercises.
SporttherapyOther
The control group performs a standardized group training session (usual care, UC) that consists of strength, endurance, coordination, balance and mobility exercises. This training is part of standard care at the Rehabilitation Clinic Valens and is therefore not personalized for each participant. The training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Balance training | Experimental | The balance training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes. The intervention is designed to meet the individual needs of pwMS and allows for challenging tasks, while guaranteeing safety by a harnass. During the first training session the appropriate exercise levels that target the adequate intensity are determined (baseline value). Moderate to high-intensive BT in this study is defined as a score of 7-9 points on the rate of perceived stability (RPS) scale and to fulfill the moderate to high-intensive characteristics on the therapists' scale. The intensity of each exercise (level of challenge during the exercise) is monitored and documented for both the therapists and pwMS. According to this feedback, progression is performed by systematically by in- or decreasing difficulty of the exercises. Receives: Other: Balance training |
| Sporttherapy | Active comparator | The control group performs a standardized group training session (usual care, UC) that consists of strength, endurance, coordination, balance and mobility exercises. This training is part of standard care at the Rehabilitation Clinic Valens and is therefore not personalized for each participant. The training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes. Receives: Other: Sporttherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance capacity
Balance capacity measured by the Mini Balance Evaluation system Test (Mini-Best). Measured with a score from 0-28, a higher score indicates a better balance capacity.
Measured: From enrollment to the end of treatment at 3 weeks.
Cognitive processing speed
Cognitive processing speed is measured with the Symbol Digit Modalities Test (SDMT). Participants receive a sheet with a key of nine numbers (1-9) and symbols shown in pairs. In boxes below only the symbols are shown, and the participants must report the correct corresponding number. The number of correct answers made within 90 seconds is assessed. The oral form of the SDMT is used due to its non-sensitivity to motor disabilities of the upper extremities. Higher scores indicate higher cognitive processing speed.
Measured: From enrollment to the end of treatment at 3 weeks.
Secondary outcomes (6)
Mobility
Mobility measured by the Timed Up and Go Test (TUG). Measurement in seconds, a lower time indicates a better functional mobility.
Measured: From enrollment to the end of treatment at 3 weeks.
Complex walking ability
Complex walking ability measured by the Six Spot Step Test (SSST). Measurement in seconds for all trials and for the trials with the dominant and non-dominant leg, a lower time indicates a better complex walking ability.
Measured: From enrollment to the end of treatment at 3 weeks.
Fatigue
Fatigue measured with the Fatigue Scale for Motor and Cognitive Function (FSMC) Questionnaire. A total score [20-100] and a motor and cognitive subscores [each 10-50] are calculated, a higher score indicates a higher fatigue.
Measured: From enrollment to the end of treatment at 3 weeks.
Walking endurance
Walking endurance measured with the 6 Minute Walking Test. Within this test the total distance [m], the 2 minute distance [m], and the steps [Number] and time [s] needed for 10 meters are measured.
Measured: From enrollment to the end of treatment at 3 weeks.
Fear of falling
Fear of falling is measured with the Falls Efficacy Scale-International (FES-I). Participants must answer 16 different questions regarding their fear of falling during activities of daily life. For each item the level of fear is assessed on a 4-point scale (from 1="not at all" to 4="very"). Scores range from 16-64, with higher scores indicating a higher fair of falling during daily activities.
Measured: From enrollment to the end of treatment at 3 weeks
Health related quality of life
Health related quality of life is measured with the Patient Reported Outcomes Measurement Information System-10 (PROMIS-10). They score each item on a 5-point scale and rate their pain from 0 to 10. The score is summarized to a mental and a physical health score, each from 0-20. With low scores indicating poor perceived health related quality of life.
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start6 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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
- Model description
- A randomized feasibility study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Bansi, Klinik Valens
- Investigators
- Jens Bansi, PhD, Principal investigator, Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805850
- Sponsor's protocol ID
- BALANCE-MS
- Acronym
- BALANCE-MS
- Status last verified
- May 2026
- First submitted
- 1 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis - a Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT07805850
- Acronym / sponsor ID
- BALANCE-MS / BALANCE-MS
- Conditions
- Multiple Sclerosis, Balance
- Keywords
- Balance, Postural Control, Intensity, Multiple Sclerosis, Walking, Gait, Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Sep 2026 (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.
Balance training is recommended to improve gait stability and mobility. However, there are currently no clearly defined methods for controlling the intensity (challenge) of balance training. This research project aims to determine whether balance training for individuals with multiple sclerosis (MS), individually tailored to the level of difficulty and exertion, is feasible and possible within an inpatient rehabilitation setting. Participants will be randomly assigned to one of two groups: either they will complete group training focusing on strength, endurance, and balance in addition to their regular therapy program, or they will receive individually tailored balance training. Both groups will undergo an initial assessment followed by seven training sessions, each lasting approximately 45-60 minutes. Before discharge, the initial assessments will be repeated. These assessments include completing questionnaires, performing gait tests, balance tests, and a short cognitive test. Interviews will also be conducted with patients and therapists. These are intended to help better assess the feasibility of the training and to gain more insight into the experiences with the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized feasibility study
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Other: Balance trainingThe balance training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes. The intervention is designed to meet the individual needs of pwMS and allows for challenging tasks, while guaranteeing safety by a harnass. During the first training session the appropriate exercise levels that target the adequate intensity are determined (baseline value). Moderate to high-intensive BT in this study is defined as a score of 7-9 points on the rate of perceived stability (RPS) scale and to fulfill the moderate to high-intensive characteristics on the therapists' scale. The intensity of each exercise (level of challenge during the exercise) is monitored and documented for both the therapists and pwMS. According to this feedback, progression is performed by systematically by in- or decreasing difficulty of the exercises. |
| Sporttherapy | Active comparator | Other: SporttherapyThe control group performs a standardized group training session (usual care, UC) that consists of strength, endurance, coordination, balance and mobility exercises. This training is part of standard care at the Rehabilitation Clinic Valens and is therefore not personalized for each participant. The training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a definite MS diagnosis according to 2024 revised McDonald criteria;
- Hold an Expanded disability status (EDSS) between 2.0-6.5;
- An inpatient stay of at least three weeks at the ;
- Aged 18 years and older;
- Have sufficient knowledge of the German language (spoken and written).
Key exclusion criteria (7 listed)
- Cognitive impairment indicated by a score of <21 on the Montreal Cognitive Assessment (MoCA);
- Severe osteoporosis;
- Fractures and/or other surgical interventions;
- Presence of any other condition that would substantially influence balance;
- Alcoholism;
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 |
|---|---|---|
| Balance trainingThe balance training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes. The intervention is designed to meet the individual needs of pwMS and allows for challenging tasks, while guaranteeing safety by a harnass. During the first training session the appropriate exercise levels that target the adequate intensity are determined (baseline value). Moderate to high-intensive BT in this study is defined as a score of 7-9 points on the rate of perceived stability (RPS) scale and to fulfill the moderate to high-intensive characteristics on the therapists' scale. The intensity of each exercise (level of challenge during the exercise) is monitored and documented for both the therapists and pwMS. According to this feedback, progression is performed by systematically by in- or decreasing difficulty of the exercises. | Other | Balance training |
| SporttherapyThe control group performs a standardized group training session (usual care, UC) that consists of strength, endurance, coordination, balance and mobility exercises. This training is part of standard care at the Rehabilitation Clinic Valens and is therefore not personalized for each participant. The training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes. | Other | Sporttherapy |
Primary outcome
Balance capacity
Time frame: From enrollment to the end of treatment at 3 weeks.
Balance capacity measured by the Mini Balance Evaluation system Test (Mini-Best). Measured with a score from 0-28, a higher score indicates a better balance capacity.
Cognitive processing speed
Time frame: From enrollment to the end of treatment at 3 weeks.
Cognitive processing speed is measured with the Symbol Digit Modalities Test (SDMT). Participants receive a sheet with a key of nine numbers (1-9) and symbols shown in pairs. In boxes below only the symbols are shown, and the participants must report the correct corresponding number. The number of correct answers made within 90 seconds is assessed. The oral form of the SDMT is used due to its non-sensitivity to motor disabilities of the upper extremities. Higher scores indicate higher cognitive processing speed.
6 secondary outcomes
Mobility
Time frame: From enrollment to the end of treatment at 3 weeks.
Complex walking ability
Time frame: From enrollment to the end of treatment at 3 weeks.
Fatigue
Time frame: From enrollment to the end of treatment at 3 weeks.
Walking endurance
Time frame: From enrollment to the end of treatment at 3 weeks.
Fear of falling
Time frame: From enrollment to the end of treatment at 3 weeks
Health related quality of life
Time frame: From enrollment to the end of treatment at 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Jens Bansi, PhD principal investigator
Klinik Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training and Sporttherapy in people with Multiple Sclerosis and Balance, run by Klinik Valens at 1 site in Switzerland.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Bansi, PhD (+41 58 511 13 02, jens.bansi@kliniken-valens.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance capacity (time frame: From enrollment to the end of treatment at 3 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 17 Sep 2026.