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Mobility Enhancing Nursing Intervention (MFP)

23. juli 2014 opdateret af: Prof. Dr. Lorenz Imhof, Zurich University of Applied Sciences

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).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Zurich
      • Winterthur, Zurich, Schweiz, 8401
        • Zurich University of Applied Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mobility-enhancing-nursing intervention
A 30 day mobility enhancing-nursing intervention for patients with Multiple Scerosis and stroke to expand kinaesthetic competence in order to increase compensation of limitations, improve functionality, and quality of life
Patients' mattresses are placed on the floor, which enables the patients to explore their environment safely without the risk of falling. Additionally, the patients' environment is arranged in accordance with a nursing assessment pertaining to the patients' impairment and abilities, their goals in terms of improved mobility, and the mobility they would require in order to live at home as independently as possible. Initially, most patients favour a specific side to get up. The goal of the intervention is to teach the patients to get up step by step and to move independently over both sides.
Ingen indgriben: Standard usual rehabilitation care
Participants in the control group will receive usual care, which is based on the principles of rehabilitation nursing. Based on patients functional ability (EBI data) the nursing process is used to determine objectives and interventions. The main focus is on providing a therapeutic environment and supporting and advancing abilities to perform the Activities of Daily Living, support mobility and kinesthetic perception.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Extended Barthel Index (EBI) between admission and discharge
Tidsramme: Data were collected before randomisation (T0), after 15 days (T1) and at discharge / 30 days (T2)
The Extended Barthel Index (EBI) is a validated and common instrument in rehabilitation settings to measure functionality. The EBI includes 16 items that are rated on a 4 and 5-point Likert scale (not possible, with support of a person, with low support, with facilities, independent). A score of 64 points indicates maximum independence.
Data were collected before randomisation (T0), after 15 days (T1) and at discharge / 30 days (T2)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Quality of life between admission and discharge
Tidsramme: Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).
Quality of life, was measured using the German version of the WHOQoL-Bref. The instrument includes 26 items that are rated on five 5-point Likert scale (very poor to very good, very dissatisfied to very satisfied, not at all to an extreme amount, not at all to extremely, never to always). The WHOQoL-Bref yields a score for general quality of life in each of four domains - physical, psychological, social, and environmental -with a score of 100 indicating maximum quality of life. Internal consistency for the subscales ranges between an alpha of 0•70 and 0•86.
Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).
Change in Fall Efficacy Scale between admission and discharge
Tidsramme: Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).
To measure fall-related self efficacy and fear of falls, the seven-item short version of the Fall Efficacy Scale (FES-I) was used. The FES-I is a well established instrument with a 4-point Likert scale. Scores range from 7 to 28. A higher score is synonymous with more fear of falls and less self-efficacy.
Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Lorenz Imhof, Prof, Zurich University of Applied Sciences, Insitute of Nursing

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2011

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

26. juni 2014

Først indsendt, der opfyldte QC-kriterier

21. juli 2014

Først opslået (Skøn)

23. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mobility-enhancing-nursing intervention

3
Abonner