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.
The study addresses core elements in the health services for individuals with MS, constituting approximately 11000 in Norway. The two-armed pilot feasibility-RCT will be performed across the MS-outpatient (MS-OP) clinic, Nordland Hospital Trust, Bodø (NLSH), and in two surrounding municipalities, including 30 employed participants who will be followed for 10-weeks. The new intervention and pathway, CoreDISTparticipation, builds on GroupCoreDIST, which is previously found effective short and long term compared to standard care. CoreDISTparticipation consists of three phases: a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST for 60 minutes, 2 times per week supplemented with home exercise programs focusing on balance, walking and physical activity. The participants will have access to exercise programs on videos through an open website at Nord University to digitally support home training. To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist (who leads the group trainings) will take place in phase b; followed by phase c) which include four weeks of outdoor group based exercises and physical activity led by a physiotherapist, for 60 minutes, 2 times per week supplemented with the same home exercise programs as in phase b. Evaluation of employment and physical activity will be conducted using an evaluation form. The control group will receive usual consultations at the MS-OP clinic, as well as a session with a physiotherapist at the MS-OP clinic, exploring possibilities for change in balance and walking. In the municipality the control group will follow standard care (their usual follow-up). The research team will examine feasibility, preliminary between-group differences regarding balance, walking, physical activity level, health related quality of life and barriers in employment, as well as the users' experiences with participation in the CoreDISTparticipation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
CoreDISTparticipation is a thorough intervention that contains coordination of services (physiotherapy, MS-nursing and work adaptations) between the MS-OP clinic and the municipality aiming to improve function, physical activity and employment in individuals with MS.
The standard care group will follow regular consultations at the MS-outpatient clinic including a session with the physiotherapist. Furthermore, this group will follow usual care in the municipality which might include other forms of physiotherapy or physical activity. These will be registered.
Bodø Municipality
Bodø, Norway
Physiotherapy department, Nordlandssykehuset HF
Bodø, Norway
MS Work Difficulties Questionnaire-23
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Time frame: Baseline
Six-Minutes Walk Test
Walking distance within six minutes
Time frame: Baseline
MS Work Difficulties Questionnaire-23
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Time frame: 5 weeks post-test
Six-Minutes Walk Test
Walking distance within six minutes
Time frame: 5 weeks post-test
MS Work Difficulties Questionnaire-23
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Time frame: 10 week post-test
Six-Minutes Walk Test
Walking distance within six minutes
Time frame: 10 week post-test
Trunk Impairment Scale Norwegian Version
Dynamic sitting balance, 6 items, top score 16.
Time frame: Baseline
Mini Balance Evaluation Systems Test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Time frame: Baseline
Force Platform
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Time frame: Baseline
Activity monitors outcome 1
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Time frame: Baseline
Activity monitors outcome 2
The monitors measure number of steps within 7 days
Time frame: Baseline
European Quality of Life 5-Dimension-3 Level
Self-perceived health related quality of life regarding five domains, each with three items, and a Visual Analog Scale (0-100) recording perceived health.
Time frame: Baseline
Multiple Sclerosis Walking Scale-12
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Time frame: Baseline
Multiple Sclerosis Impact Scale-29
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Time frame: baseline
Weight
Self reported weight by kilogram
Time frame: baseline
Height
Self reported height by centimetre
Time frame: baseline
age
Self reported age by years
Time frame: baseline
Social status
Self reported social status; married, cohabitant, living alone
Time frame: baseline
Type of multiple sclerosis
Self reported main types: relapsing remitting, primary progressive, secondary progressive
Time frame: baseline
Year of diagnosis multiple sclerosis
Self reported by year
Time frame: baseline
Medications
Self reported by type of medications
Time frame: baseline
Expanded disability status scale
Self reported or from journal functional status at last yearly control by a neurologist
Time frame: baseline
Occupation
Self reported
Time frame: baseline
Percentage of work
Self reported percentage of work the previous month
Time frame: baseline
Length of education
Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
Time frame: baseline
Trunk Impairment Scale Norwegian Version
Dynamic sitting balance, 6 items, top score 16.
Time frame: 5 weeks post-test
Mini Balance Evaluation Systems Test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Time frame: 5 weeks post-test
Force Platform
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Time frame: 5 weeks post-test
Activity monitors outcome 1
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Time frame: 5 weeks post-test
Activity monitors outcome 2
The monitors measure number of steps within 7 days
Time frame: 5 weeks post-test
European Quality of Life 5-Dimension-3 Level
Self-perceived health related quality of life regarding
Time frame: 5 weeks post-test
Multiple Sclerosis Walking Scale-12
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Time frame: 5 weeks post-test
Multiple Sclerosis Impact Scale-29
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Time frame: 5 weeks post-test
Percentage of work
Self reported percentage of work
Time frame: 5 weeks post-test
Trunk Impairment Scale Norwegian Version
Dynamic sitting balance, 6 items, top score 16.
Time frame: 10 weeks post-test
Mini Balance Evaluation Systems Test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Time frame: 10 weeks post-test
Force Platform
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Time frame: 10 weeks post-test
Activity monitors outcome 1
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Time frame: 10 weeks post-test
Activity monitors outcome 2
The monitors measure number of steps within 7 days
Time frame: 10 weeks post-test
European Quality of Life 5-Dimension-3 Level
Self-perceived health related quality of life regarding
Time frame: 10 weeks post-test
Multiple Sclerosis Walking Scale-12
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Time frame: 10 weeks post-test
Multiple Sclerosis Impact Scale-29
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Time frame: 10 weeks post-test
Percentage of work
Self reported percentage of work
Time frame: 10 weeks post-test
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