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

NCT02522962 | Unknown

• 1 other identifier: 2015/1715 REK
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

physical therapy; group-based; core stability; balance; movement quality; somatosensory stimulation; coordination

Outcome Measures

Primary Outcomes (8)

• Trunk Impairment Scale modified Norwegian Version

  The outcome measures sitting balance

  Baseline

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

  The outcome measures sitting balance

  1 week post intervention

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

  The outcome measures sitting balance

  3 months post intervention

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

  The outcome measures sitting balance

  6 months post intervention

• Mini-Balance Evaluation Systems Test

  The outcome measures standing and walking balance

  baseline

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

  The outcome measures standing and walking balance

  1 week post intervention

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

  The outcome measures standing and walking balance

  3 months post intervention

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

  The outcome measures standing and walking balance

  6 months post intervention

Secondary Outcomes (35)

• 10-Meter Walk Test

  Baseline

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

  1 week post intervention

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

  3 months post intervention

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

  6 months post intervention

• 2-Minutes Walk Test

  Baseline

Study Arms (2)

GroupCoreSIT

EXPERIMENTAL

Before the group training starts, the physiotherapist in charge of the group does a clinical assessment of each participant in order to individualise the training. Each training group will consist of three participants. The training sessions will last for 60 minutes, performed three days per week, for six weeks, between 10 am and 5 pm.

Behavioral: GroupCoreSIT

Standard care

ACTIVE COMPARATOR

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.

Behavioral: Standard care

Interventions

GroupCoreSIT BEHAVIORAL

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.

Also known as: Group based individualised stability training, Group based individualised balance training

GroupCoreSIT

Standard care BEHAVIORAL

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.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nordlandssykehuset HF: lead
• Helse Nord: collaborator
• University of Tromso: collaborator
• University Hospital of North Norway: collaborator
• Hasselt University: collaborator
• University of Memphis: collaborator

Study Sites (1)

Physiotherapy department, Nordlandssykehuset HF

Bodø, Norway

Location

Related Publications (1)

• Arntzen EC, Straume BK, Odeh F, Feys P, Zanaboni P, Normann B. Group-Based Individualized Comprehensive Core Stability Intervention Improves Balance in Persons With Multiple Sclerosis: A Randomized Controlled Trial. Phys Ther. 2019 Aug 1;99(8):1027-1038. doi: 10.1093/ptj/pzz017.

  PMID: 30722036 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Britt Normann, PhD

  Nordlandssykehuset HF

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 14, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-02

Locations

NO (1)