Multiple SclerosisHiBalance-MSNCT06312046
Motor-cognitive Performance in People With Multiple Sclerosis
A study testing HiBalance-MS in people with Multiple Sclerosis and Postural Balance, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Having a neurological disease such as multiple sclerosis (MS) leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Postural Balance
- What is being tested?
- HiBalance-MS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 26 Feb 2024to 31 Aug 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- an MS diagnosis according to McDonald criteria;
- an overall MS-disability score from 2.0 to 5.5 according to the Expanded Disability Status Scale;
- ability to walk 100 m without aid;
- a maximum score of 24 in the Mini-BESTest (i.e., < 25 points)
- 18 to 65 years of age
Who cannot join
- cognitive impairment as indicated by a score <21 in the Montreal Cognitive Assessment;
- presence of other conditions that would substantially influence balance;
- an MS relapse or change of disease-modifying treatment within the past 8 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, Stockholm County, 17177
Sverker Johansson, Ph.D, +46702861260, sverker.johansson@ki.se
Andreas Wallin, Ph.D, +46735137604, andreas.wallin@ki.se
About this study
Official title: Motor-cognitive Performance in People With Multiple Sclerosis - Brain Activity and Effects of Balance Exercise
Having a neurological disease such as multiple sclerosis (MS) leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.
The investigators have adapted a previously developed balance training program to a highly challenging program specifically directed to MS (HiBalance-MS). This program was recently tested and found feasible in a pilot study. The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of the program. The hypothesis is that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life.
Read the detailed description
Everyday living means being in complex environments and performing complex activities which usually consist of and require a combination of motor and cognitive skills. Having a neurological disease such as multiple sclerosis (MS) compromises the motor-cognitive performance. This leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.
The investigators have, in a co-design process with stakeholders, adapted a HiBalance program, originally developed by the Franzén research group for people with Parkinson's disease and combining motor-cognitive exercises in a progressively more difficult manner (HiBalance-PD), to a program specifically developed to MS (HiBalance-MS). The developed HiBalance-MS program was recently tested and found feasible in a pilot study (results published 2023). The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of a highly challenging balance training program (HiBalance-MS) on physical and cognitive functioning, and activity performance, in this group. The results will have immediate application and clinical relevance. With improved balance control people with MS will also gain other health benefits related to an active lifestyle and a better everyday life.
The hypothesis that motor-cognitive performance is reduced and impact activity performance in people with MS. They also hypothesize that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life.
Participants will be recruited through Karolinska University Hospital, through physiotherapists and physicians specialized in neurology in Stockholm and via advertisement in newspapers and the patient organization NEURO Sweden. According to earlier power calculations for detecting effects in balance and gait measures after this particular intervention, the investigators anticipate 40 to 50 participants in each group to detect significant changes.
The HiBalance-MS program is based on scientifically well-established principles of exercise training and postural control. It will be conducted as a progressive individually adjusted group training to challenge the specific balance deficit of every participant. Four main sub-systems underlying balance control (stability limits, anticipatory postural adjustments, sensory integration and motor agility) are used to target specific balance impairments. To ensure highly challenging exercises, each task is individually adjusted. Daily variation in capacity will be rated before each training session and participants will at the end of each session rate the challenging level. The training will be performed in the clinic (Karolinska University hospital) for an hour, twice a week for 10 weeks, as a group intervention (6 to 8 participants) facilitated by two physiotherapists/trainers.
- Conditions
- Multiple Sclerosis, Postural Balance
- Being tested
- HiBalance-MS
- Keywords
- Balance, Exercise, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiBalance-MSOther
See arm description for intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Balance training intervention group | Experimental | The program HiBalance-MS is based on scientifically well-established principles of exercise training and postural control. It will be conducted as a progressive individually adjusted group training to challenge the specific balance deficit of every participant. To ensure highly challenging exercises, each task is individually adjusted, e.g., by altering the base of support, increasing speed, restricting vision and varying grade of multitasking. Daily variation in capacity will be rated before each training session and participants will at the end of each session rate the challenging level. The training will be performed in the clinic, at Karolinska University Hospital, for an hour, twice a week for 10 weeks, as a group intervention including 6 to 8 participants and facilitated by two physiotherapists/trainers. Receives: Other: HiBalance-MS |
| No intervention control group | No intervention | Participants in the control group are encouraged to maintain their normal physical activities and are not restricted from participation in ongoing rehabilitation programs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Balance Evaluation Systems test.
Balance performance. A rating scale for dynamic balance incorporating 14 different balance and gait items that are assessed by a physical therapist on a scale from 0-2. Points between 0 and 28; a higher total score indicates better balance control.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Secondary outcomes (29)
10-Meter Walk Test, maximum speed.
Gait performance. Maximum gait speed (meter/second), a higher score indicates higher gait speed.
Measured: Pre intervention baseline and post intervention at 10 weeks.
10-Meter Walk Test, self-selected speed.
Gait performance. Self-selected comfortable gait speed (meter/second), a higher score indicates higher self-selected comfortable gait speed.
Measured: Pre intervention baseline and post intervention at 10 weeks.
2-Minute Walk Test, self-selected speed.
Gait performance. Self-selected gait speed (meter/second), a higher score indicates higher self-selected endurance gait speed.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Gait speed during simultaneous dual task performance.
Gait speed (meter/second), will be analyzed during dual task walking with the Ambulatory Parkinson´s Disease Monitoring (APDM) mobility Lab system. Dual tasking during walking will be performed with the Auditory stroop task, a test of cognitive function, see below. A higher score indicates higher gait speed during dual tasking,
Measured: Pre intervention baseline and post intervention at 10 weeks.
Stride length during dual task gait performance.
Stride length (meter) during gait will be analyzed during dual task walking with the Ambulatory Parkinson´s Disease Monitoring (APDM) mobility Lab system. Dual tasking during walking will be performed with the Auditory stroop task, a test of cognitive function, see below.Longer stride length indicates better control during walking,
Measured: Pre intervention baseline and post intervention at 10 weeks.
Step time during dual task gait performance.
Step time during gait (seconds) will be analyzed during dual task walking with the Ambulatory Parkinson´s Disease Monitoring (APDM) mobility Lab system. Dual tasking during walking will be performed with the Auditory stroop task, a test of cognitive function, see below. Shorter step time indicates better control during walking,
Measured: Pre intervention baseline and post intervention at 10 weeks.
Response errors in dual task cognitive performance
Dual task cognitive performance during walking will be performed with the Auditory stroop task, a test of cognitive flexibility in selective executive functions. Cognitive performance of the dual task will be assessed as errors in the response (numbers) to the Auditory stroop task. Data colllection is performed through wireless headphones (RazerTM ManO'War) using Audacity software (version 3.0.2).
Measured: Pre intervention baseline and post intervention at 10 weeks.
Reaction time in dual task cognitive performance
Dual task cognitive performance during walking will be performed with the Auditory stroop task, a test of cognitive flexibility in selective executive functions. Cognitive performance of the dual task will be assessed as reaction time (seconds) in the Auditory stroop task. Data colllection is performed through wireless headphones (RazerTM ManO'War) using Audacity software (version 3.0.2).
Measured: Pre intervention baseline and post intervention at 10 weeks.
Six-Spot Step Test.
A test of complex walking. The Six-Spot Step Test is a 5 meter test-field criss-cross walk pattern where the subject while walking is simultaneously kicking wooden blocks from marked circles in the field. Mean time (seconds) of four trials is calculated, shorter time indicates better complex walking performance.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Completion time in the Trail Making Test.
The Trail Making Test (from Delis-Kaplan Executive Function System) assesses attention and psychomotor processing speed. The time (seconds) to complete the test, connecting numbers and letters correctly, is registered. Shorter completion time indicates better attention and higher psychomotor processing speed.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Number of errors in the Trail Making Test.
The Trail Making Test (from Delis-Kaplan Executive Function System) assesses attention and psychomotor processing speed. The number of mistakes/errors is registered. Less number of mistakes/errors indicates better attention and higher psychomotor processing speed.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Immediate and delayed recall in the Ray Auditory Verbal Learning Test.
The Ray Auditory Verbal Learning Test assesses episodic memory. In this test 15 words is repeatedly (five times) read for the subject. The subject is asked to recall as many as possible. The subject is asked again after 30 minutes to recall as many words as possible. The test assesses immediate recall (number) and delayed recall (number) of words where higher number of immediate and delayed recalled words indicates better episodic memory.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Cognitive processing speed in the Symbol Digit Modalities Test.
The Symbol Digit Modalities Test assesses cognitive processing speed. The subject is asked to pair specific numbers with given symbols. The number of correctly paired numbers and symbols within 90 seconds is registered where a higher number indicates higher cognitive processing speed.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Cognitive function - composite measure of three cognitive tests.
Cognitive function will also be assessed as a composite measure of a cognitive test battery consisting of: Trail making Test (from Delis-Kaplan Executive Function System), testing attention and and psychomotor processing speed); Ray Auditory Verbal Learning Test, assessment of episodic memory; and Symbol Digit Modalities Test, assessment of cognitive processing speed. First, the scores of each of the three tests will be standardised into z-scores using pre-scores. Models using different test are compared. The model including all three tests and using the robust diagonally weighted least square estimation will be chosen based on fit values. Last, the z-scores of each test and person are multiplied with the factor loadings and added together to create a sum score for each person and time point. A higher value = greater executive functions.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Physical activity level.
Assessment with accelerometer Actigraph GT3X+. Participants wear the accelerometer around the hip, attached slightly above the iliac crest with an elastic band. They wear the accelerometer in their daily life for seven consecutive days (minimum four days), only removing it when showering, bathing, swimming, and at night. As a proxy for the level of daily physical activity, the number of steps per day will be used, where a higher number indicates higher level of physical activity.
Measured: Pre-and-post-intervention over four to seven days when awake.
Physical activity level, self-reported.
Frändin \& Grimby Scale, a self-reported questionnaire (score 1-6, higher score = higher physical activity level measured in hours,
Measured: Pre intervention baseline and post intervention at 10 weeks.
Physical exercise habits, self-reported.
A question regarding physical exercise habits is included (from The Swedish Research Council). Score 1-6, A higher score indicates larger interval of minutes per week used for physical exercise.
Measured: Pre intervention baseline and post intervention at 10 weeks.
The generic Walk-12 questionnaire.
Self assessment of walking ability with the generic Walk-12 questionnaire. A total of 12 questions, possibility to score from 1 to 5. Total score between12 and 60. A higher score indicates perceived more limited walking ability.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Falls Efficacy Scale - International.
A self-reported questionnaire regarding falls efficacy, A total of 16 questions, score 1-4. Total score from 16 to 64 points, a higher total score = more concerned of falling.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Assesment of anxiety with the Hospital Anxiety and Depression Scale.
A self-reported questionnaire assessing anxiety and depression. Total score from 0 to 28 points, 14 points each on the depression and anxiety parts respectively. Lower scores on the anxiety part indicates less anxiety.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Assesment of depression with the Hospital Anxiety and Depression Scale.
A self-reported questionnaire assessing anxiety and depression. Total score from 0 to 28 points, 14 points each on the depression and anxiety parts respectively. Lower scores on the depression part indicates less depression.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Modified Fatigue Impact Scale.
A self-reported questionnaire which measures impact of fatigue on physical, cognitive and psychosocial functioning, The scale consists of 21 items, scored from 0 to 4. Total score ranges from 0 to 84 points. Higher scores indicate larger impact of fatigue (total impact or impact in physical, cognitive and psychosocial functioning.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Occupational Gap Questionnaire.
A self-reported questionnaire measuring participation in everyday activities. The questionnaire includes 30 questions regarding if an activity is performed and regarding if the person wants to perform the activity. Number of activities performed (higher scores = better) and number of wanted but not performed activities (higher scores = worse) are counted .
Measured: Pre intervention baseline and post intervention at 10 weeks.
Acceptance of Chronic Health Condition scale.
A self-reported questionnaire (10 questions scored on a 5 category Likert rating scale measuring acceptance of chronic health condition. Scores from 1 to 50), a higher score = higher level of acceptance.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Multiple Sclerosis Impact Scale - physical impact.
A self-reported diagnose-specific questionnaire assessing health-related quality of life. A total of 29 items (20 physical and 9 psychological). Items are rated from 1 to 5. Total score ranges from 20 to 100 in physical impact. Higher total score = worse physical impact.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Multiple Sclerosis Impact Scale - psychological impact.
A self-reported diagnose-specific questionnaire assessing health-related quality of life. A total of 29 items (20 physical and 9 psychological). Items are rated from 1 to 5. Total scores range from 9 to 45 in psychological impact. Higher total score = worse psychological impact.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Euroqol-5 Dimensions-5 Level (EuroQoL-5D-5L).
A self-reported generic questionnaire measuring health-related quality of life. The questionnaire assesses five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels - higher level score = increased disability.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Euroqol Visual Analogue Scale (EQ VAS).
A self-reported generic questionnaire measuring health-related quality of life. In addition to the five dimensions of health (as described above) the EuroQoL-5D-5L includes a vertical visual analogue scale (the EQ VAS), which records the patient's self-rated health on the vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0).
Measured: Pre intervention baseline and post intervention at 10 weeks.
World Health Organization Disability Assessment Schedule, version 2.0. (WHODAS 2.0)
A self-reported questionnaire consisting of 12 questions assessing disability. Total score from12 to 60, a higher score = worse disability.
Measured: Pre intervention baseline and post intervention at 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start26 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Aug 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.
- More trials run by Karolinska InstitutetThe 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
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Sverker Johansson, Karolinska Institutet
- Investigators
- Sverker Johansson, Ph.D, Principal investigator, Karolinska Institutet, org.nr 202100-2973
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312046
- Sponsor's protocol ID
- 2018 374-31
- Acronym
- HiBalance-MS
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and European Union personal data legislation but are available from the principal investigator on reasonable request. Any sharing of data will be regulated via a data transfer and user agreement with the recipient.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor-cognitive Performance in People With Multiple Sclerosis - Brain Activity and Effects of Balance Exercise
- ClinicalTrials.gov ID
- NCT06312046
- Acronym / sponsor ID
- HiBalance-MS / 2018 374-31
- Conditions
- Multiple Sclerosis, Postural Balance
- Keywords
- Balance, Exercise, Multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 15 Mar 2024 (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.
Having a neurological disease such as multiple sclerosis (MS) leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.
The investigators have adapted a previously developed balance training program to a highly challenging program specifically directed to MS (HiBalance-MS). This program was recently tested and found feasible in a pilot study. The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of the program. The hypothesis is that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life.
Detailed description
Everyday living means being in complex environments and performing complex activities which usually consist of and require a combination of motor and cognitive skills. Having a neurological disease such as multiple sclerosis (MS) compromises the motor-cognitive performance. This leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.
The investigators have, in a co-design process with stakeholders, adapted a HiBalance program, originally developed by the Franzén research group for people with Parkinson's disease and combining motor-cognitive exercises in a progressively more difficult manner (HiBalance-PD), to a program specifically developed to MS (HiBalance-MS). The developed HiBalance-MS program was recently tested and found feasible in a pilot study (results published 2023). The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of a highly challenging balance training program (HiBalance-MS) on physical and cognitive functioning, and activity performance, in this group. The results will have immediate application and clinical relevance. With improved balance control people with MS will also gain other health benefits related to an active lifestyle and a better everyday life.
The hypothesis that motor-cognitive performance is reduced and impact activity performance in people with MS. They also hypothesize that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life.
Participants will be recruited through Karolinska University Hospital, through physiotherapists and physicians specialized in neurology in Stockholm and via advertisement in newspapers and the patient organization NEURO Sweden. According to earlier power calculations for detecting effects in balance and gait measures after this particular intervention, the investigators anticipate 40 to 50 participants in each group to detect significant changes.
The HiBalance-MS program is based on scientifically well-established principles of exercise training and postural control. It will be conducted as a progressive individually adjusted group training to challenge the specific balance deficit of every participant. Four main sub-systems underlying balance control (stability limits, anticipatory postural adjustments, sensory integration and motor agility) are used to target specific balance impairments. To ensure highly challenging exercises, each task is individually adjusted. Daily variation in capacity will be rated before each training session and participants will at the end of each session rate the challenging level. The training will be performed in the clinic (Karolinska University hospital) for an hour, twice a week for 10 weeks, as a group intervention (6 to 8 participants) facilitated by two physiotherapists/trainers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Balance training intervention group | Experimental | Other: HiBalance-MSThe program HiBalance-MS is based on scientifically well-established principles of exercise training and postural control. It will be conducted as a progressive individually adjusted group training to challenge the specific balance deficit of every participant. To ensure highly challenging exercises, each task is individually adjusted, e.g., by altering the base of support, increasing speed, restricting vision and varying grade of multitasking. Daily variation in capacity will be rated before each training session and participants will at the end of each session rate the challenging level. The training will be performed in the clinic, at Karolinska University Hospital, for an hour, twice a week for 10 weeks, as a group intervention including 6 to 8 participants and facilitated by two physiotherapists/trainers. |
| No intervention control group | No intervention | –Participants in the control group are encouraged to maintain their normal physical activities and are not restricted from participation in ongoing rehabilitation programs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- an MS diagnosis according to McDonald criteria;
- an overall MS-disability score from 2.0 to 5.5 according to the Expanded Disability Status Scale;
- ability to walk 100 m without aid;
- a maximum score of 24 in the Mini-BESTest (i.e., < 25 points)
- 18 to 65 years of age
Key exclusion criteria (3 listed)
- cognitive impairment as indicated by a score <21 in the Montreal Cognitive Assessment;
- presence of other conditions that would substantially influence balance;
- an MS relapse or change of disease-modifying treatment within the past 8 weeks
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 |
|---|---|---|
| HiBalance-MSSee arm description for intervention group. | Other | Balance training intervention group |
Primary outcome
Mini Balance Evaluation Systems test.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Balance performance. A rating scale for dynamic balance incorporating 14 different balance and gait items that are assessed by a physical therapist on a scale from 0-2. Points between 0 and 28; a higher total score indicates better balance control.
29 secondary outcomes
10-Meter Walk Test, maximum speed.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
10-Meter Walk Test, self-selected speed.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
2-Minute Walk Test, self-selected speed.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Gait speed during simultaneous dual task performance.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Stride length during dual task gait performance.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Step time during dual task gait performance.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Response errors in dual task cognitive performance
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Reaction time in dual task cognitive performance
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Six-Spot Step Test.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Completion time in the Trail Making Test.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Number of errors in the Trail Making Test.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Immediate and delayed recall in the Ray Auditory Verbal Learning Test.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Cognitive processing speed in the Symbol Digit Modalities Test.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Cognitive function - composite measure of three cognitive tests.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Physical activity level.
Time frame: Pre-and-post-intervention over four to seven days when awake.
Physical activity level, self-reported.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Physical exercise habits, self-reported.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
The generic Walk-12 questionnaire.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Falls Efficacy Scale - International.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Assesment of anxiety with the Hospital Anxiety and Depression Scale.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Assesment of depression with the Hospital Anxiety and Depression Scale.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Modified Fatigue Impact Scale.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Occupational Gap Questionnaire.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Acceptance of Chronic Health Condition scale.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Multiple Sclerosis Impact Scale - physical impact.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Multiple Sclerosis Impact Scale - psychological impact.
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Euroqol-5 Dimensions-5 Level (EuroQoL-5D-5L).
Time frame: Pre intervention baseline and post intervention at 10 weeks.
Euroqol Visual Analogue Scale (EQ VAS).
Time frame: Pre intervention baseline and post intervention at 10 weeks.
World Health Organization Disability Assessment Schedule, version 2.0. (WHODAS 2.0)
Time frame: Pre intervention baseline and post intervention at 10 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 10 Jul 2025.
- Publication: A highly challenging balance training intervention for people with multiple sclerosis: a feasibility trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and European Union personal data legislation but are available from the principal investigator on reasonable request. Any sharing of data will be regulated via a data transfer and user agreement with the recipient.
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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.
Sverker Johansson, Ph.D principal investigator
Karolinska Institutet, org.nr 202100-2973
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HiBalance-MS in people with Multiple Sclerosis and Postural Balance, run by Karolinska Institutet at 1 site in Sweden.
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 3 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 10 Jul 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 Sweden. 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 Compliance Office Karolinska Institutet (+46852480000, compliance@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Balance Evaluation Systems test. (time frame: Pre intervention baseline and post intervention at 10 weeks.). 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 10 Jul 2025.