Physical Function, Health and Employment for People With Multiple Scle

Tailored Follow-up for Persons With Multiple Sclerosis to Optimize Physical Functions, Health and Employment: a Prospective Single-blinded Randomized Controlled Trial

Running, not recruitingNot a drug-phase studyMS (type not specified)NCT06110468

What it found

Still running

No result yet.

What was tested

Treatment tested

  • CoreDISTParticipation

What it measured

Main measures

  • Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version

    Baseline, 9, 16 and 52 weeks post baseline

    Thinking and memory

  • Levels of physical activity measured using ActiGraph wGT3x-BT monitors

    Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline

    Physical function

Other measures (10)

  • 6 meter walk test

    Baseline, 9, 16 and 52 weeks post baseline

    Walking and mobility

  • Step count using ActiGraph wGT3x-BT monitors

    Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline

  • Fatigue Severity Scale -Norwegian version

    Baseline, 9, 16 and 52 weeks post baseline

    Thinking and memoryFatigue

  • Multiple Sclerosis Walking Scale-12

    Baseline, 9, 16 and 52 weeks post baseline

    Walking and mobility

  • Mini Balance Evaluation Systems Test (MiniBESTest)

    Baseline, 9, 16 and 52 weeks post baseline

    Walking and mobility

  • Trunk Impairment Scale-modified Norwegian version (TISmodNV)

    Baseline, 9, 16 and 52 weeks post baseline

  • Postural control measured by AccuGait Optimized force platforms

    Baseline, 9, 16 and 52 weeks post baseline

    Walking and mobility

  • European Quality of Life 5-Dimension (EQ-5D-5L) + Complementary questions

    Baseline, 9, 16 and 52 weeks post baseline

    Mood and sleepQuality of life (reported by participants)

  • Multiple Sclerosis Impact Scale 29-Norwegian version

    Baseline, 9, 16 and 52 weeks post baseline

  • Patient Global Impression of Change - physical activity and balance

    Baseline, 9, 16 and 52 weeks post baseline

    Walking and mobilityPhysical function

Who could take part

MS (type not specified) · 18 to 67 · EDSS 0 to 4

Show the full criteria

Inclusion criteria

* Diagnosed with Multiple Sclerosis according to the McDonald's criteria * Extended Disability Status Scale (EDSS) 0-4 * Being employed, part time or full time, may include various degrees of sick leave, disability pension or AAP. * Living in the participating 18 municipalities (Hammerfest, Alta, Senja, Målselv, Tromsø, Harstad, Narvik, Fauske, Bodø, Meløy, Vågan, Vestvågøy, Sortland, Hadsel, Rana, Vefsn, Alstadhaug, Brønnøy).

Exclusion criteria

* Pregnancy at enrolment. * Exacerbation of symptoms (i.e. relapse) within two weeks prior to enrolment. * Other serious conditions.

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

About this trial

In the sponsor's words

Employment is low in people with MS, even when physical levels of functioning are high. The purpose of this study is to investigate if an individually tailored intervention combining individualized physiotherapy and work adaptation works better than usual care in terms of reducing barriers for work and improving levels of physical activity. The utility of the intervention will be investigated in terms of quality adjusted life years, long-term employment status and work-related costs.

Papers

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History

    1. Started

      Mar 2024

    2. Main results due

      Dec 2024

    3. Finished

      Dec 2035

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