Motor-cognitive Performance in People With Multiple Sclerosis

NCT06312046 | Recruiting

• 1 other identifier: 2018 374-31
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Postural Balance

Keywords

Balance; Exercise; Multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre intervention baseline and post intervention at 10 weeks.

Secondary Outcomes (29)

• 10-Meter Walk Test, maximum speed.

  Pre intervention baseline and post intervention at 10 weeks.

• 10-Meter Walk Test, self-selected speed.

  Pre intervention baseline and post intervention at 10 weeks.

• 2-Minute Walk Test, self-selected speed.

  Pre intervention baseline and post intervention at 10 weeks.

• Gait speed during simultaneous dual task performance.

  Pre intervention baseline and post intervention at 10 weeks.

• Stride length during dual task gait performance.

  Pre intervention baseline and post intervention at 10 weeks.

Study Arms (2)

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.

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.

Interventions

HiBalance-MS OTHER

See arm description for intervention group.

Balance training intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• to 65 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, 17177, Sweden

RECRUITING

Related Links

• Publication: A highly challenging balance training intervention for people with multiple sclerosis: a feasibility trial

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Sverker Johansson, Ph.D

  Karolinska Institutet, org.nr 202100-2973

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Compliance Office Karolinska Institutet

CONTACT

+46852480000; compliance@ki.se

Erika Franzén, Ph.D

CONTACT

+46852480000; erika.franzen@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and Outcome assessor will not participate in the provided training program. Care provider will not perform the analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 15, 2024
• Study Start: February 26, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: The investigators plan to share this when applicable on the Open Science Platform or similar.
• Access Criteria: 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.

Locations

SE (1)