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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02522962
• Date of registration: 10/08/2015
• Prospective Registration: Yes
• Primary sponsor: Nordlandssykehuset HF
• Public title: Innovative Physiotherapy and Coordination of Care for People With MS: a RCT and a Qualitative Study GroupCoreSIT
• Scientific title: Innovative Physiotherapy and Coordination of Care for People With Multiple Sclerosis: a Randomised Controlled Trial and a Qualitative Study
• Date of first enrolment: September 2015
• Target sample size: 80
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02522962
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Britt Normann, PhD
• Affiliation: Nordlandssykehuset HF

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Behavioral: Standard care

Behavioral: GroupCoreSIT

Primary Outcome(s)

Measure change in the outcome: Trunk Impairment Scale modified Norwegian Version [Time Frame: 1 week post intervention]

Mini-Balance Evaluation Systems Test [Time Frame: baseline]

Measure a change in the outcome: Mini-Balance Evaluation Systems Test [Time Frame: 6 months post intervention]

Measure a change in the outcome: Mini-Balance Evaluation Systems Test [Time Frame: 1 week post intervention]

Measure a change in the outcome:Mini-Balance Evaluation Systems Test [Time Frame: 3 months post intervention]

Measure change in the outcome: Trunk Impairment Scale modified Norwegian Version [Time Frame: 3 months post intervention]

Measure a change in the outcome: Trunk Impairment Scale modified Norwegian Version [Time Frame: 6 months post intervention]

Trunk Impairment Scale modified Norwegian Version [Time Frame: Baseline]

Secondary Outcome(s)

ActiGraph activity monitor. [Time Frame: baseline]

Measure a change in the outcome:Health Questionnaire (EQ-5D-3L) [Time Frame: 6 months post intervention]

Measure a change in the outcome: 10 Meter Walk Test [Time Frame: 6 months post intervention]

Measure a change in the outcome: MS Walking Scale-12 [Time Frame: 6 months post intervention]

Measure a change in the outcome: Patient Global Impression of Change [Time Frame: 3 months post intervention]

Measure a change in the outcome: Patient Global Impression of Change [Time Frame: 6 months post intervention]

Measure a change in the outcome:2-MinutesWalk Test [Time Frame: 3 months post intervention]

Measure a change in the outcome:MS Walking Scale-12 [Time Frame: 3 months post intervention]

Health Questionnaire (EQ-5D-3L) [Time Frame: Baseline]

Measure a change in the outcome:MS Walking Scale-12 [Time Frame: 1 week post intervention]

Measure a change in the outcome:Multiple Sclerosis Impact Scale-29 [Time Frame: 3 months post intervention]

Rivermead Visual Gait Assessment [Time Frame: Baseline]

Measure a change in the outcome:Multiple Sclerosis Quality of Life-54 (MSQOL-54) [Time Frame: 3 months post intervention]

Measure a change in the outcome:Multiple Sclerosis Quality of Life-54 (MSQOL-54) [Time Frame: 6 months post intervention]

Measure a change in the outcome: 2-Minutes Walk Test [Time Frame: 1 week post intervention]

Measure a change in the outcome:10 Meter Walk Test [Time Frame: 3 months post intervention]

Measure a change in the outcome:2-Minutes Walk Test [Time Frame: 6 months post intervention]

Measure a change in the outcome:ActiGraph activity monitor [Time Frame: 3 months post intervention]

Measure a change in the outcome:ActiGraph activity monitor. [Time Frame: 1 week post intervention]

Measure a change in the outcome:Health Questionnaire (EQ-5D-3L) [Time Frame: 1 week post intervention]

Measure a change in the outcome:Multiple Sclerosis Impact Scale-29 [Time Frame: 6 months post intervention]

MS Walking Scale-12 [Time Frame: Baseline]

Measure a change in the outcome:Multiple Sclerosis Impact Scale-29 [Time Frame: 1 week post intervention]

Measure a change in the outcome:Rivermead Visual Gait Assessment [Time Frame: 6 months post intervention]

Multiple Sclerosis Impact Scale-29 [Time Frame: Baseline]

Multiple Sclerosis Quality of Life-54 (MSQOL-54) [Time Frame: Baseline]

Measure a change in the outcome:Rivermead Visual Gait Assessment [Time Frame: 1 week post intervention]

The Patient Global Impression of Change [Time Frame: 1 week post intervention]

10-Meter Walk Test [Time Frame: Baseline]

Measure a change in the outcome: 10 Meter Walk Test [Time Frame: 1 week post intervention]

Measure a change in the outcome:Multiple Sclerosis Quality of Life-54 (MSQOL-54) [Time Frame: 1 week post intervention]

Measure a change in the outcome:Rivermead Visual Gait Assessment [Time Frame: 3 months post intervention]

2-Minutes Walk Test [Time Frame: Baseline]

Measure a change in the outcome:ActiGraph activity monitor [Time Frame: 6 months post intervention]

Measure a change in the outcome:Health Questionnaire (EQ-5D-3L) [Time Frame: 3 months post intervention]

Secondary ID(s)

2015/1715 REK

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital of North Norway

Helse Nord

University of Tromso

Hasselt University

University of Memphis