Not yet recruitingNot a drug-phase studyRelapsing and progressiveNCT07878702

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Dual-task balance training

What it measured

Main measures

  • Retention rate

    Week 7 after baseline

    MRI lesionsFeasibility
  • Adherence to the training

    From baseline to the end of intervention phase (7 weeks)

    Quality of life (reported by participants)

Other measures (31)

  • Assessment burden

    Baseline and week 7 after baseline

  • Change in timed up and go dual-task cost

    From baseline to the end of intervention phase (7 weeks)

    Walking and mobility
  • Change in 2 minutes walking test dual-task cost

    From baseline to the end of intervention phase (7 weeks)

    Walking and mobility
  • Change in cognitive dual-task cost

    From baseline to the end of intervention phase (7 weeks)

    Thinking and memory
  • Change in EEG Task Load Index

    From baseline to the end of intervention phase (7 weeks)

    Walking and mobilityNerve conduction tests
  • Change in prefrontal EEG theta power

    From baseline to the end of intervention phase (7 weeks)

    Walking and mobilityNerve conduction tests
  • Change in perceived workload

    From baseline to the end of intervention phase (7 weeks)

  • Change in perceived fatigue

    From baseline to the end of intervention phase (7 weeks)

    Fatigue
  • Patient Global Impression of Change

    At the end of the intervention phase (week 7 after baseline)

  • Change in MSWS-12

    From baseline to the end of intervention phase (7 weeks)

    Walking and mobility

Who could take part

Relapsing and progressive · 18 to 75

Inclusion Criteria: * Age 18 to 75 years * Diagnosis of multiple sclerosis (relapsing-remitting, primary progressive or secondary progressive) * Timed Up and Go test > 8.4 s * Expanded Disability Status Scale (EDSS) score \< 7 * Able to walk independently for 2 minutes * Written informed consent Exclusion Criteria: * Other conditions that may affect motor function * Cognitive impairment (Mini-Mental State Examination score \< 24) * Severe visual deficits

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

The goal of this randomized controlled feasibility study is to assess whether a balance training program that includes dual-task exercises is feasible in people with multiple sclerosis (MS). The study also aims to obtain preliminary data on the effects of the training on walking under dual-task conditions and on brain activity recorded with a wearable EEG. The main questions it aims to answer are: * Is the training feasible in terms of recruitment, retention, adherence, data completeness, and assessment burden? * What are the preliminary effects of the training on dual-task costs during the Timed Up and Go test (TUG) and the 2-Minute Walk Test (2MWT), on prefrontal activation and mental workload during walking, and on clinical outcomes? Researchers will compare participants who receive the training with participants who receive no additional rehabilitation during the study period. Participants will: * receive 14 in-hospital sessions of balance and dual-task training (60 minutes, 2 sessions per week, about 7 weeks) if allocated to the intervention group, or no new rehabilitation if allocated to the control group; * perform a dual-task walking assessment (TUG, 2MWT, backward digit span) while wearing an 8-channel wearable EEG headset and 3 inertial sensors, before (T0) and after (T1) the study period; * complete clinical scales and questionnaires on balance, gait, cognition, fatigue, mood, pain, and quality of life.

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History

    1. Started

      Oct 2026

    2. Main results due

      Jul 2029

    3. Finished

      Sept 2029

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