Stroke Clinical Trial
Official title:
Effects of Mobility-Enhancing Nursing Intervention in Patients With MS and Stroke: Randomised Controlled Trial
Objectives: This parallel RCT investigated the effect of a new nursing intervention
(Mobility Enhancing Nursing Intervention - MFP) designed to improve the rehabilitation
programs' outcomes and patients' quality of life.
Intervention: The IG combined standard care with the 30-day mobility-enhancing-nursing
intervention (MFP). MFP placed patients on a mattress on the floor and used constant
tactile-kinaesthetic stimulation in everyday tasks to increase spatial orientation, to teach
patients to get up safely and to move independently.
Primary and secondary outcome measures: Outcomes were defined as functionality (Extended
Barthel Index, EBI), quality of life (WHOQoL), and fall-related self-efficacy (FES-I).
In Switzerland 100`000 people live with the consequences of neurological events and
illnesses. Most events are caused by cerebral vascular events, accidents, tumors and
illnesses such as Multiple Sclerosis (MS).
Despite the fact that symptoms and disabilities vary based on underlying causes and
individual manifestations, common in all those patients is a significant impairment in
sensory function, orientation, and mobility that present a great challenge for the affected
persons, their families and the health care providers.
Over the years nurses in addition to other health care providers in the rehabilitation
Center Valens, SG, have developed and refined interventions to specifically enhance
patients' safety, body perception, kinesthetic competence, mobility and functionality, and
to reduce burdens of care. The approach that has shown great promise is the mobility
enhancing nursing intervention referred to as "Mobilitätsfördernde Pflegeintervention
(MfP)".
In a first retrospective descriptive study Suter-Riederer et al (2008)) showed a significant
improvement in functional status of daily activities in agitated patients due to MfP.
Method A randomized-control trial will be conducted utilizing a mixed-method design in the
Neurological Clinic at the Rehabilitation Center Valens and 165 patient with stroke, MS and
brain injuries will be enrolled.Demographic, medical, and functional data as well as quality
of life measure will be obtained. Patients' experiences and perspectives will be explored
with narrative interviews.
Descriptive and inferential statistics, with p value set to .05, will be deployed to analyze
quantitative data. Constant comparative analysis will be used for qualitative data.
Expected results We hypothesize that the group with MfP has better score increase on the
Extended Barthel Index, has less fear of falling on the Fall Efficacy Scale after 30 days
and higher quality of life than the usual care group after 30 days and one months after
discharge. Additionally we hypothesize that the MfP group has less falls and longer time to
first fall than the usual care group. Secondary outcomes will be enhanced movement patterns
and kinaesthetic competence in the intervention group compared with the control.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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