NCT06312046 Motor-cognitive Performance in People With Multiple Sclerosis
| NCT ID | NCT06312046 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-02-26 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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
Contact & Investigator
Sverker Johansson, Ph.D
PRINCIPAL INVESTIGATOR
Karolinska Institutet, org.nr 202100-2973
Frequently Asked Questions
Who can join the NCT06312046 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06312046 currently recruiting?
Yes, NCT06312046 is actively recruiting participants. Contact the research team at compliance@ki.se for enrollment information.
Where is the NCT06312046 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06312046 clinical trial?
NCT06312046 is sponsored by Karolinska Institutet. The principal investigator is Sverker Johansson, Ph.D at Karolinska Institutet, org.nr 202100-2973. The trial plans to enroll 90 participants.
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