NCT02198599

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

2.1 years

First QC Date

June 26, 2014

Last Update Submit

July 23, 2014

Conditions

Keywords

Multiple sclerosisStrokeNursingMobilityRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in Extended Barthel Index (EBI) between admission and discharge

    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)

Secondary Outcomes (2)

  • Change in Quality of life between admission and discharge

    Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).

  • Change in Fall Efficacy Scale between admission and discharge

    Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).

Study Arms (2)

Mobility-enhancing-nursing intervention

EXPERIMENTAL

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

Procedure: Mobility-enhancing-nursing intervention

Standard usual rehabilitation care

NO INTERVENTION

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.

Interventions

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.

Mobility-enhancing-nursing intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who are agitated and cannot consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich University of Applied Sciences

Winterthur, Canton of Zurich, 8401, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

StrokeMultiple Sclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Lorenz Imhof, Prof

    Zurich University of Applied Sciences, Insitute of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 26, 2014

First Posted

July 23, 2014

Study Start

March 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations