Innovative Physiotherapy and Coordination of Care for People With Multiple Sclerosis: a Randomised Controlled Trial and a Qualitative Study

Status unknownNot a drug-phase studyMS (type not specified)NCT02522962

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

  • GroupCoreSIT

Compared with

  • Standard care

What it measured

Main measures

  • Trunk Impairment Scale modified Norwegian Version

    Baseline

    Walking and mobility
  • Measure change in the outcome: Trunk Impairment Scale modified Norwegian Version

    1 week post intervention

    Walking and mobility
  • Measure change in the outcome: Trunk Impairment Scale modified Norwegian Version

    3 months post intervention

    Walking and mobility
  • Measure a change in the outcome: Trunk Impairment Scale modified Norwegian Version

    6 months post intervention

    Walking and mobility
  • Mini-Balance Evaluation Systems Test

    baseline

    Walking and mobility
  • Measure a change in the outcome: Mini-Balance Evaluation Systems Test

    1 week post intervention

    Walking and mobility
  • Measure a change in the outcome:Mini-Balance Evaluation Systems Test

    3 months post intervention

    Walking and mobility
  • Measure a change in the outcome: Mini-Balance Evaluation Systems Test

    6 months post intervention

    Walking and mobility

Other measures (35)

  • 10-Meter Walk Test

    Baseline

    Walking and mobility
  • Measure a change in the outcome: 10 Meter Walk Test

    1 week post intervention

    Walking and mobility
  • Measure a change in the outcome:10 Meter Walk Test

    3 months post intervention

    Walking and mobility
  • Measure a change in the outcome: 10 Meter Walk Test

    6 months post intervention

    Walking and mobility
  • 2-Minutes Walk Test

    Baseline

    Walking and mobility
  • Measure a change in the outcome: 2-Minutes Walk Test

    1 week post intervention

    Walking and mobility
  • Measure a change in the outcome:2-MinutesWalk Test

    3 months post intervention

    Walking and mobility
  • Measure a change in the outcome:2-Minutes Walk Test

    6 months post intervention

    Walking and mobility
  • Rivermead Visual Gait Assessment

    Baseline

    Walking and mobility
  • Measure a change in the outcome:Rivermead Visual Gait Assessment

    1 week post intervention

    Walking and mobility

Who could take part

MS (type not specified) · 18 and over · EDSS 1 to 6.5

Show the full criteria

Inclusion criteria

* Diagnosis of MS (McDonald's criteria) * EDSS 1-6.5 (minimal symptoms - able to walk 20 minimum meter with two crutches) * Minimum 14 days post exacerbation * Age >18 years * Capable to provide signed written informed consent

Exclusion criteria

* Pregnancy at enrolment * Acute orthopedic conditions affecting balance and walking

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

About this trial

In the sponsor's words

This project comprises a two-arm randomized controlled trial (RCT) complemented by qualitative research on innovative group-based intervention for people with Multiple Sclerosis (MS) performed in the primary health care and organized in collaboration with the services provided by a hospital's outpatient clinic. The RCT will be conducted by Nordland Hospital Trust, Bodø (NLSH), in collaboration with UiT The Arctic University of Norway (UiT) and the Norwegian Centre for Integrated Care and Telemedicine, University Hospital North Norway (NST). The overall purpose of the RCT is to demonstrate whether high-intensity individualised group-based core stability training (GroupCoreSIT) performed by physiotherapists (PTs) in the primary health care has effect on balance, walking and activities of daily living (ADL) in people with MS compared to standard care. Changes in quality of life and costs will also be studied to conclude whether the intervention is cost-effective. The qualitative study contains three parts. The first part aims to investigate users' experiences from participating in the new group intervention and in standard care. The researchers will particularly focus on reflections regarding content, feasibility, potential changes in ADL, self-management, and continuity of care. The second part will investigate how the PTs act and interact with the group while conducting the intervention, particularly how individualization is carried out, and the PTs' reflections from participating in the education and performance of the intervention. The third part explores health professionals' reflections regarding coordination of care in people with MS.

Papers

Loading reviews and guidelines…

History

    1. Started

      Sept 2015

    2. Main results due

      Sept 2016

    3. Finished

      Dec 2019

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