Employment is low in people with MS, even when physical levels of functioning are high. The purpose of this study is to investigate if an individually tailored intervention combining individualized physiotherapy and work adaptation works better than usual care in terms of reducing barriers for work and improving levels of physical activity. The utility of the intervention will be investigated in terms of quality adjusted life years, long-term employment status and work-related costs.
Physiotherapy and physical activity interventions can reduce fatigue, improve balance, walking, HRQoL, and may improve neuromuscular and physical functioning in people with MS. However, these interventions lack coordination between health care levels and sectors and rarely address vital employment adaptations. Optimizing function and physical activity, when disability is low and neuroplasticity is optimal, can be valuable for maintaining work as levels of fatigue, mobility related symptoms and cognitive disturbances are associated with current employment. People with an MS-diagnosis who reside in the North of Norway will be identified from patient lists from the neurological out-patient clinics in the participating hospitals. Upon the provision of written informed consent, all participants will undergo baseline testing prior to randomization into either the intervention or the control group. The intervention group will receive a physiotherapy assessment at the hospitals focusing on opportunities for change. Following this assessment they will participate in group training with a municipality physiotherapist twice weekly for six weeks followed by independent training for six weeks. In addition, both participants and their employers will get access to information films on opportunities for work adaptations and the importance of physical activity. Structured meetings with a specially trained employment consultant, the participant and their employer will be held to discuss possible work adaptations. Goals will be set and formally evaluated. Retests will be carried out at week 9, 16 and 52. Registry data on employment will be obtained from the Norwegian labour and welfare administration as a part of a cost-benefit analysis of the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
114
CoreDISTparticipation is a multi-disciplinary individualized intervention that concurrently combine 1) providing PwMS and their employers with information on MS, possibilities for work-adaptations within the welfare system and the importance of physical activity 2) Structured goal-setting regarding reducing barriers for work and regarding physical function and activity for PwMS 3) A physiotherapy intervention focusing on improving the underlying prerequisites for balance and walking along with high intensive training and promotion of physical activity 4) structured evaluation and adjustment of goals.
Nordlandssykehuset HF
Bodø, Nordland, Norway
Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version
How frequently individuals with MS perceive psychological/cognitive (11 items), physical (8 items), external, (4 items) barriers related to work, scored by a 5-point scale (0=best).
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Levels of physical activity measured using ActiGraph wGT3x-BT monitors
% of time in mild, moderate, intensive physical activity and sedate time
Time frame: Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline
6 meter walk test
Walking distance (meters) within six minutes
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Step count using ActiGraph wGT3x-BT monitors
Daily average number of steps
Time frame: Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline
Fatigue Severity Scale -Norwegian version
Self-report, 9 items: physical, social and cognitive effects of fatigue, scale:1-7 (high score indicates higher levels of fatigue).
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Multiple Sclerosis Walking Scale-12
Self-reported perception of walking, 12 items, score on a 5-point scale. Higher score indicate higher impact of MS on the individuals walking ability.
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Mini Balance Evaluation Systems Test (MiniBESTest)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3-point scale. Higher score indicate better performance.
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Trunk Impairment Scale-modified Norwegian version (TISmodNV)
Trunk control in sitting. 6 items, score on a 2- or 3-point scale, sum range 0-16 points. Higher score indicates higher levels of trunk control.
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Postural control measured by AccuGait Optimized force platforms
Measures postural control in standing, tandem, one-leg standing: postural sway of center of pressure.
Time frame: Baseline, 9, 16 and 52 weeks post baseline
European Quality of Life 5-Dimension (EQ-5D-5L) + Complementary questions
Self-perceived HRQoL regarding five domains, and a VAS scale (0-100) on overall health. Complementary questions on sleep, wellbeing, emotions, social relations (advocated by the Norwegian Health Institute). Higher score indicate better self-perveived health.
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Multiple Sclerosis Impact Scale 29-Norwegian version
Self-perceived physical (13 items), psychological (9 items) impact on HRQoL, a 5-point scale. Higher score indicate increased impact of MS on the individuals day-to-day life.
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Patient Global Impression of Change - physical activity and balance
A global index that is used to rate the response of a condition to a therapy (transition scale). Higher score indicate improvement.
Time frame: Baseline, 9, 16 and 52 weeks post baseline