Innovative Follow-up Across Health Care Levels to Optimize Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study

Status unknownNot a drug-phase studyMS (type not specified)NCT05057338

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • CoreDISTparticipation

Compared with

  • Standard care

What it measured

Main measures

  • MS Work Difficulties Questionnaire-23

    Baseline

    Thinking and memory
  • Six-Minutes Walk Test

    Baseline

    Walking and mobility
  • MS Work Difficulties Questionnaire-23

    5 weeks post-test

    Thinking and memory
  • Six-Minutes Walk Test

    5 weeks post-test

    Walking and mobility
  • MS Work Difficulties Questionnaire-23

    10 week post-test

    Thinking and memory
  • Six-Minutes Walk Test

    10 week post-test

    Walking and mobility

Other measures (37)

  • Trunk Impairment Scale Norwegian Version

    Baseline

    Walking and mobility
  • Mini Balance Evaluation Systems Test

    Baseline

    Walking and mobility
  • Force Platform

    Baseline

    Walking and mobility
  • Activity monitors outcome 1

    Baseline

    Physical function
  • Activity monitors outcome 2

    Baseline

  • European Quality of Life 5-Dimension-3 Level

    Baseline

    Quality of life (reported by participants)
  • Multiple Sclerosis Walking Scale-12

    Baseline

    Walking and mobility
  • Multiple Sclerosis Impact Scale-29

    baseline

    Quality of life (reported by participants)
  • Weight

    baseline

  • Height

    baseline

Who could take part

MS (type not specified) · 18 to 68

Show the full criteria

Inclusion criteria

* Diagnosed with MS (Mc Donald's criteria), Expanded Disability Status Scale ≤3.5 (no disability-fully ambulatory with moderate disability), ≥18 years, being employed. By these criteria the study will include individuals most accessible for the intervention and who have the best prospects to maintain/improve balance, walking, physical activity and participation in employment.

Exclusion criteria

* Retired, pregnancy at enrolment, exacerbation within two weeks prior to enrolment and other serious conditions compromising balance, walking or work capacity.

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

About this trial

In the sponsor's words

Multiple Sclerosis (MS) is a chronic disease affecting young adults. Impaired balance, walking, reduced physical activity and participation in employment are common, however, less integrated in the health care. The researchers have developed a multidisciplinary intervention and pathway delivered across health care levels targeting the promotion of balance, walking, physical activity and participation in employment. The research team will perform a pilot feasibility Randomized Controlled Trial (RCT) and interviews to investigate the feasibility of the new intervention compared to a standard care for individuals with lower levels of disability.

Papers

Loading reviews and guidelines…

History

    1. Started

      Aug 2021

    2. Main results due

      Dec 2021

    3. Finished

      Aug 2022

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