Clinical trial NCT02198599: Mobility Enhancing Nursing Intervention
Official title: Effects of Mobility-Enhancing Nursing Intervention in Patients With MS and Stroke: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Multiple Sclerosis
Keywords: Multiple sclerosis
Stroke
Nursing
Mobility
Rehabilitation
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2014-07-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with multiple sclerosis, stroke, or brain injuries;
* German-speaking;
* Age 18 and older;
* Cognitively able to give written consent.

Exclusion Criteria:

* Patients who are agitated and cannot consent.

Primary outcomes:
measure: Change in Extended Barthel Index (EBI) between admission and discharge
timeFrame: Data were collected before randomisation (T0), after 15 days (T1) and at discharge / 30 days (T2)
Secondary outcomes:
measure: Change in Quality of life between admission and discharge
timeFrame: Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).
measure: Change in Fall Efficacy Scale between admission and discharge
timeFrame: Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Zurich University of Applied Sciences
state: Zurich
Study officials:
affiliation: Zurich University of Applied Sciences, Insitute of Nursing
name: Lorenz Imhof, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imhof L, Suter-Riederer S, Kesselring J. Effects of Mobility-Enhancing Nursing Intervention in Patients with MS and Stroke: Randomised Controlled Trial. Int Sch Res Notices. 2015 Feb 17;2015:785497. doi: 10.1155/2015/785497. eCollection 2015.