Innovative Physiotherapy and Coordination of Care for People With MS: a RCT and a Qualitative Study

Summary

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.

Conditions

• Multiple Sclerosis

Interventions

BEHAVIORAL

GroupCoreSIT

Each group session lasts for 60 minutes. The physiotherapist will chose from an "exercises bank" of 32 exercises, each having up 5 levels of difficulty that are described and illustrated by photos. All exercises demand core activation, emphasise normal movement and emphasise somatosensory integration, feed forward and feed back strategies essential for balance.10-12 repetitions for each exercise with good quality of movement will be performed. Every session will start with exploring standing balance and end with active stretching/active relaxation, re-exploring balance and instructions for home exercises. The participants will perform 30-minute of exercises, optional to divide into smaller intervals, at home two days per week when there are no organized group training.

BEHAVIORAL

Standard care

The control group receive standard care, which means to follow their ordinary physiotherapy services and/or routines/activities. The content of standard care may vary, and will be recorded for all the participants.

Sponsors & Collaborators

• Helse Nord

  collaborator INDUSTRY

• University of Tromso

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Hasselt University

  collaborator OTHER

• University of Memphis

  collaborator OTHER

• Nordlandssykehuset HF

  lead OTHER

Principal Investigators

• Britt Normann, PhD · Nordlandssykehuset HF

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2016-09-30

Completion

2019-12-31

Countries

• Norway

Study Locations