StrokeMFPNCT02198599
Mobility Enhancing Nursing Intervention
A study testing Mobility-enhancing-nursing intervention in people with Stroke and Multiple Sclerosis, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Multiple Sclerosis
- What is being tested?
- Mobility-enhancing-nursing intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with multiple sclerosis, stroke, or brain injuries;
- German-speaking;
- Age 18 and older;
- Cognitively able to give written consent.
Who cannot join
- Patients who are agitated and cannot consent.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Zurich University of Applied Sciences
Winterthur, Canton of Zurich, 8401
About this study
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).
Read the 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.
- Conditions
- Stroke, Multiple Sclerosis
- Being tested
- Mobility-enhancing-nursing intervention
- Keywords
- Multiple sclerosis, Stroke, Nursing, Mobility, Rehabilitation
- Medical subject headings
- Stroke, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility-enhancing-nursing interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).
Change in Fall Efficacy Scale between admission and discharge
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.
Measured: Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Prof. Dr. Lorenz Imhof, Zurich University of Applied Sciences
- Investigators
- Lorenz Imhof, Prof, Principal investigator, Zurich University of Applied Sciences, Insitute of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198599
- Sponsor's protocol ID
- 13DPD6_132090
- Other IDs
- 09/021
- Acronym
- MFP
- Status last verified
- Jul 2014
- First submitted
- 26 Jun 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27347547
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobility-Enhancing Nursing Intervention in Patients With MS and Stroke: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02198599
- Acronym / sponsor ID
- MFP / 13DPD6_132090
- Conditions
- Stroke, Multiple Sclerosis
- Keywords
- Multiple sclerosis, Stroke, Nursing, Mobility, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobility-enhancing-nursing intervention | Experimental | Procedure: Mobility-enhancing-nursing interventionA 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with multiple sclerosis, stroke, or brain injuries;
- German-speaking;
- Age 18 and older;
- Cognitively able to give written consent.
Key exclusion criteria (1 listed)
- Patients who are agitated and cannot consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobility-enhancing-nursing interventionPatients' 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. | Procedure or surgery | Mobility-enhancing-nursing intervention |
Primary outcome
Change in Extended Barthel Index (EBI) between admission and discharge
Time frame: 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.
2 secondary outcomes
Change in Quality of life between admission and discharge
Time frame: Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).
Change in Fall Efficacy Scale between admission and discharge
Time frame: Data were collected before randomisation (T0), after 15 days (T1) and at discharge (T2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Derived from this study: PubMed 27347547Imhof 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenz Imhof, Prof principal investigator
Zurich University of Applied Sciences, Insitute of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility-enhancing-nursing intervention in people with Stroke and Multiple Sclerosis, run by Zurich University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Extended Barthel Index (EBI) between admission and discharge (time frame: Data were collected before randomisation (T0), after 15 days (T1) and at discharge / 30 days (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02198599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.