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

RecruitingNot a drug-phase studyMS (type not specified)NCT06312046

What it found

Still running

No result yet.

What was tested

Treatment tested

  • HiBalance-MS

What it measured

Main measures

  • Mini Balance Evaluation Systems test.

    Pre intervention baseline and post intervention at 10 weeks.

    Walking and mobility

Other measures (29)

  • 10-Meter Walk Test, maximum speed.

    Pre intervention baseline and post intervention at 10 weeks.

    Walking and mobility
  • 10-Meter Walk Test, self-selected speed.

    Pre intervention baseline and post intervention at 10 weeks.

    Walking and mobility
  • 2-Minute Walk Test, self-selected speed.

    Pre intervention baseline and post intervention at 10 weeks.

    Walking and mobility
  • Gait speed during simultaneous dual task performance.

    Pre intervention baseline and post intervention at 10 weeks.

    Thinking and memoryWalking and mobility
  • Stride length during dual task gait performance.

    Pre intervention baseline and post intervention at 10 weeks.

    Thinking and memoryWalking and mobility
  • Step time during dual task gait performance.

    Pre intervention baseline and post intervention at 10 weeks.

    Thinking and memoryWalking and mobility
  • Response errors in dual task cognitive performance

    Pre intervention baseline and post intervention at 10 weeks.

    Thinking and memoryWalking and mobility
  • Reaction time in dual task cognitive performance

    Pre intervention baseline and post intervention at 10 weeks.

    Thinking and memoryWalking and mobility
  • Six-Spot Step Test.

    Pre intervention baseline and post intervention at 10 weeks.

    Walking and mobility
  • Completion time in the Trail Making Test.

    Pre intervention baseline and post intervention at 10 weeks.

    Thinking and memory

Who could take part

MS (type not specified) · 18 to 65

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Feb 2024

    2. Main results due

      Dec 2025

    3. Finished

      Aug 2027

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