ClinicalTrials.gov record NCT06312046

Motor-cognitive Performance in People With Multiple Sclerosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Motor-cognitive Performance in People With Multiple Sclerosis - Brain Activity and Effects of Balance Exercise

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old to 65 years old
SexAll
LocationSweden
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized trial compares a 10-week, individually adjusted group balance program (HiBalance-MS) with a no-intervention control in people with multiple sclerosis who have balance problems. Training is one hour, twice weekly in groups of 6–8, led by two physiotherapists. Participants are assessed before and after the 10-week period on balance, walking, cognitive tasks, and quality-of-life measures.

What it is studying. The study tests the effects of a progressively challenging, motor-cognitive balance training program (HiBalance-MS) on balance control, walking performance, cognitive and motor-cognitive tasks, activity performance, and health-related quality of life in people with multiple sclerosis. The official title also indicates interest in related brain activity measures.

What the researchers hope to learn. The study aims to learn whether a targeted, progressively challenging balance exercise program changes balance control, walking, motor-cognitive performance, activity performance, and health-related quality of life in people with MS, and to investigate related measures such as brain activity.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • HiBalance-MS

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will be randomly assigned to either the HiBalance-MS group training or a no-intervention control. The HiBalance-MS training is offered as 1-hour group sessions, twice weekly for 10 weeks, with groups of 6–8 participants led by two physiotherapists; exercises are progressively and individually adjusted and you will rate daily capacity and session challenge. Before the program and again after 10 weeks you will complete physical and cognitive assessments (balance and walking tests, cognitive tests), wear an activity monitor for several days, and fill in questionnaires about function, mood and quality of life. No invasive procedures are listed in the record.

How the study is structured. Interventional, randomized, parallel-group trial with double masking. Participants are randomly assigned to either the HiBalance-MS group training (1 hour, twice weekly for 10 weeks, in small groups) or to a no-intervention control group that continues usual activities. Assessments occur at baseline (pre-intervention) and after the 10-week intervention period.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Multiple Sclerosis; Postural Balance. Does it apply to my diagnosis?
  • The listed sites are in Sweden. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on tuberous sclerosis complex

Important dates

Study start
Feb 26, 2024
Primary completion
Dec 31, 2025 (estimated)
Study completion
Aug 31, 2027 (estimated)
Target enrollment
90 participants (estimated)
Last updated on registry
Jul 10, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Karolinska Institutet
Principal investigator
Sverker Johansson, Associate professor
Karolinska Institutet
Collaborators
  • Karolinska University Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
relapse
A condition that improved with treatment and has since returned or worsened.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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