StrokeNCT03271788
Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training
A study testing Mindfulness, MBSR in people with Stroke and Relatives, run by Zurich University of Applied Sciences.
Trial summary
The main purpose of the study is to find out if MBSR (Mindfulness) in addition to occupational therapy, can improve the therapeutic results in stroke-patients and help relatives of stroke patients to improve their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Relatives, Motor Disorder
- What is being tested?
- Mindfulness, MBSR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 31 Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants (out-patients) fulfilling all of the following inclusion criteria are eligible for the study:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Adult stroke patients (outpatients) who gets regular occupational therapy
- Time after stroke at least 6 months
- Modified Rankin Scale ≥1≤ 4
- Mini Mental State ≥ 24
- Participants (caregivers) fulfilling all of the following inclusion criteria are eligible for the study:
- Close relative who is primary in charge and bear the largest burden of the caregiving of the stroke patient
Who cannot join
- Co-Morbidity (e.g. severe psychological, neurological disorders)
- Severe cognitive disorders
- Severe speech comprehension disorders
- Known or suspected drug, medication or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study to Evaluate the Effect of MBSR on Motor Learning, Attention, and Quality of Life in Stroke Patients and Their Relatives- a Monocentric Study
The main purpose of the study is to find out if MBSR (Mindfulness) in addition to occupational therapy, can improve the therapeutic results in stroke-patients and help relatives of stroke patients to improve their quality of life.
Read the detailed description
The study seeks primarily to determine the effect of Mindfulness (conducted additionally to occupational therapy) on physical and mental capabilities of life of stroke patients.
Furthermore, we want to find out if Mindfulness has a positive impact towards the quality of life and the daily burden of stroke patients and their caregivers.
The overall purpose of this study is to evaluate the feasibility of the process-basis, resources-basis, management-basis, and scientific basis for a further larger study. We want to conduct an exploratory case study as an A-B Design in which the A-Phase is "only regular occupational therapy" (no additive intervention) and the B-Phase contains the "regular occupational therapy" and "MBSR" (Mindfulness-Course; intervention).
Four stroke patients and their closest relative will be included in the study (n=8).
The study is non-blinded and no randomised allocation will take place. We will compare the outcomes of Phase B with the outcomes of Phase A of every person.
The purpose of the exploratory case study is to analyse the feasibility of the study design that will be used in a subsequent research study.
The study will last 16 weeks; split into two parts of eight weeks (A Phase and B-Phase).
- Baseline Measurement If the patient and the caregivers are included into the study they perform several measurements and questionnaires:
- Measurements to assess physical capabilities (Patient)
- Measurement to assess attention (Patient)
- Measurements to assess Quality of life daily burden of illness and caregiving (Patient and Caregiver
- Semi structured Interviews (Patient and Caregiver)
- A-Phase The stroke patient continues his/her regular occupational treatment for eight weeks. The caregivers get no study-related treatment.
- 2nd (Midterm)-Measurement Same procedure as the baseline measurement.
- B-Phase (Intervention Phase) Within the B-Phase of the study, the participant gets Mindfulness Training (intervention) in addition to the regular occupational therapy. Before Patients and Caregivers start the MBSR Course (Mindfulness) the get information from an experienced Mindfulness trainer about e.g. duration, contents of the course, etc. They have the opportunity to ask questions. The course lasts eight weeks. The MBSR group meet every week for 2.5h. The participants will get "homework" that they to perform at home (1h per day). If the duration of practice is to burdensome for the participants, then they can talk to the MBSR-trainer about time reduction.
- 3rd (Final) Measurement Same procedure as the baseline and second (Midterm-) measurement.
- Conditions
- Stroke, Relatives, Motor Disorder, Attention Deficit, Quality of Life
- Being tested
- Mindfulness, MBSR
- Medical subject headings
- Stroke, Motor Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness, MBSROther
Participants (stroke patients and one of their closest relatives) will conduct an MBSR Course in Phase B
| Study group | Role | What they receive |
|---|---|---|
| stroke patients and caregivers | Experimental | Stroke patients will conduct two phases ( A-Phase: regular occupational therapy; B-Phase occupational therapy with additional mindfulness) Caregivers of the patients will conduct the MBSR Course (Mindfulness) together with their relatives (Phase B). In Phase A they will not receive any treatment. Receives: Other: Mindfulness, MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks (Wolf et al., 1995). The first 6 items involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. Performance is rated on a scale (Wolf et al., 2005) from 1("does not attempt with UE being tested") to 6 ("appears normal"). Lower scores indicate lower functioning levels. Since a maximum of 120 s is allocated to each item, it is estimated to take approximately 30 min with additional time for measuring grip strength (item 14).
Measured: 20min
Motor Activity LOG (MAL)
The MAL is a scripted structured interview to measure real-works upper extremity function. Patients have to assess their capabilities of the upper limb in terms of
- How often do they use the affected limb in their everyday live and
- How would they evaluate the quality of the use? (Taub et al, 2011)
Measured: Time of performance: ca. 15 min
Assessment of Motor and Process Skills (AMPS)
The purpose of the AMPS is to evaluate a person's quality of performance of personal or instrumental activities of daily living (ADL) by observing the person doing the task (e.g. cooking a pancake, put on socks, etc.) The AMPS is used to test a person in a relevant and familiar environment as he or she performs ADL tasks that have been prioritized by the client.
It measures the degree to which a person's ADL task performances are free of increased clumsiness or physical effort, decreased efficiency, safety risk, and/or need for assistance.
It is possible to score the quality of 16 ADL motor and 20 ADL process performance skills and facilitate occupation-focused documentation and occupation-based intervention planning. (Downloaded from website: http://www.innovativeotsolutions.com/content/amps/ )
Measured: 50min
ASPA (Attention and Performance Self-Assessment)
The purpose of the self-assessment questionnaire ASPA is to evaluate and analyse a person's memory and attention that is necessary in everyday tasks.
Measured: 5min
WHOQoL-BREF (for patients and caregivers)
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
The WHOQOL-BREF self-assessment was completed, together with socio-demographic and health status questions. Analyses of internal consistency, item-total correlations, discriminant validity and construct validity through confirmatory factor analysis, indicate that the WHOQOL-BREF has well to excellent psychometric properties of reliability and performs well in preliminary tests of validity. These results indicate that overall, the WHOQOL-BREF is a sound, cross-culturally valid assessment of QOL (Skevington et al, 2004).
Measured: 20 min
EQ-5D
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics, and in face-to-face interviews. It is cognitively undemanding, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire (Oemar et al., 2013)
Measured: 5 min
Pictorial Representation of Illness and Self Measure (PRISM) (patients and caregivers)
The PRISM is a tool used to represent the burden of an illness graphically.in relation to oneself and one's life measured with the Self-Illness-Separation (SIS) instrument (Streffer et al., 2009; Kassardjian et al., 2008)
Measured: 10min
Burden Scale of family caregivers BSFC (Häusliche Pflegeskala) only caregivers
The Burden Scale of Family Caregivers (BSFC) is a 28-item questionnaire developed ot measure the levels of perceived burden of family caregivers. The BSFC is designed for use
- to identify individual caregiver service needs, plan intervention, and evaluate progress in clinical practice.
- to evaluate service effectiveness of a program and to predict caregiver health and caregiving situation in research studies.
Measured: 10min
Secondary outcomes (1)
Semi-structured Interview (patients and caregivers)
Different topics that are important for the patients and the caregivers will be discussed e.g.
- Change in family-roles and relationship, handling of dependencies
- Daily burden, strain, daily problems
- Coping strategies
- Etc.
Measured: 60min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Dec 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silke Neumann, Zurich University of Applied Sciences
- Investigators
- Silke Neumann, MSC, Principal investigator, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271788
- Sponsor's protocol ID
- 97106125033101
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Effect of MBSR on Motor Learning, Attention, and Quality of Life in Stroke Patients and Their Relatives- a Monocentric Study
- ClinicalTrials.gov ID
- NCT03271788
- Acronym / sponsor ID
- 97106125033101
- Conditions
- Stroke, Relatives, Motor Disorder, Attention Deficit, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 5 Sep 2017 (actual)
- 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.
The main purpose of the study is to find out if MBSR (Mindfulness) in addition to occupational therapy, can improve the therapeutic results in stroke-patients and help relatives of stroke patients to improve their quality of life.
Detailed description
The study seeks primarily to determine the effect of Mindfulness (conducted additionally to occupational therapy) on physical and mental capabilities of life of stroke patients.
Furthermore, we want to find out if Mindfulness has a positive impact towards the quality of life and the daily burden of stroke patients and their caregivers.
The overall purpose of this study is to evaluate the feasibility of the process-basis, resources-basis, management-basis, and scientific basis for a further larger study. We want to conduct an exploratory case study as an A-B Design in which the A-Phase is "only regular occupational therapy" (no additive intervention) and the B-Phase contains the "regular occupational therapy" and "MBSR" (Mindfulness-Course; intervention).
Four stroke patients and their closest relative will be included in the study (n=8).
The study is non-blinded and no randomised allocation will take place. We will compare the outcomes of Phase B with the outcomes of Phase A of every person.
The purpose of the exploratory case study is to analyse the feasibility of the study design that will be used in a subsequent research study.
The study will last 16 weeks; split into two parts of eight weeks (A Phase and B-Phase).
- Baseline Measurement If the patient and the caregivers are included into the study they perform several measurements and questionnaires:
- Measurements to assess physical capabilities (Patient)
- Measurement to assess attention (Patient)
- Measurements to assess Quality of life daily burden of illness and caregiving (Patient and Caregiver
- Semi structured Interviews (Patient and Caregiver)
- A-Phase The stroke patient continues his/her regular occupational treatment for eight weeks. The caregivers get no study-related treatment.
- 2nd (Midterm)-Measurement Same procedure as the baseline measurement.
- B-Phase (Intervention Phase) Within the B-Phase of the study, the participant gets Mindfulness Training (intervention) in addition to the regular occupational therapy. Before Patients and Caregivers start the MBSR Course (Mindfulness) the get information from an experienced Mindfulness trainer about e.g. duration, contents of the course, etc. They have the opportunity to ask questions. The course lasts eight weeks. The MBSR group meet every week for 2.5h. The participants will get "homework" that they to perform at home (1h per day). If the duration of practice is to burdensome for the participants, then they can talk to the MBSR-trainer about time reduction.
- 3rd (Final) Measurement Same procedure as the baseline and second (Midterm-) measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patients and caregivers | Experimental | Other: Mindfulness, MBSRStroke patients will conduct two phases ( A-Phase: regular occupational therapy; B-Phase occupational therapy with additional mindfulness) Caregivers of the patients will conduct the MBSR Course (Mindfulness) together with their relatives (Phase B). In Phase A they will not receive any treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants (out-patients) fulfilling all of the following inclusion criteria are eligible for the study:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Adult stroke patients (outpatients) who gets regular occupational therapy
- Time after stroke at least 6 months
- Modified Rankin Scale ≥1≤ 4
Key exclusion criteria (5 listed)
- Co-Morbidity (e.g. severe psychological, neurological disorders)
- Severe cognitive disorders
- Severe speech comprehension disorders
- Known or suspected drug, medication or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language
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 |
|---|---|---|
| Mindfulness, MBSRParticipants (stroke patients and one of their closest relatives) will conduct an MBSR Course in Phase B | Other | stroke patients and caregivers |
Primary outcome
Wolf Motor Function Test
Time frame: 20min
The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks (Wolf et al., 1995). The first 6 items involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. Performance is rated on a scale (Wolf et al., 2005) from 1("does not attempt with UE being tested") to 6 ("appears normal"). Lower scores indicate lower functioning levels. Since a maximum of 120 s is allocated to each item, it is estimated to take approximately 30 min with additional time for measuring grip strength (item 14).
Motor Activity LOG (MAL)
Time frame: Time of performance: ca. 15 min
The MAL is a scripted structured interview to measure real-works upper extremity function. Patients have to assess their capabilities of the upper limb in terms of 1. How often do they use the affected limb in their everyday live and 2. How would they evaluate the quality of the use? (Taub et al, 2011)
Assessment of Motor and Process Skills (AMPS)
Time frame: 50min
The purpose of the AMPS is to evaluate a person's quality of performance of personal or instrumental activities of daily living (ADL) by observing the person doing the task (e.g. cooking a pancake, put on socks, etc.) The AMPS is used to test a person in a relevant and familiar environment as he or she performs ADL tasks that have been prioritized by the client. It measures the degree to which a person's ADL task performances are free of increased clumsiness or physical effort, decreased efficiency, safety risk, and/or need for assistance. It is possible to score the quality of 16 ADL motor and 20 ADL process performance skills and facilitate occupation-focused documentation and occupation-based intervention planning. (Downloaded from website: http://www.innovativeotsolutions.com/content/amps/ )
ASPA (Attention and Performance Self-Assessment)
Time frame: 5min
The purpose of the self-assessment questionnaire ASPA is to evaluate and analyse a person's memory and attention that is necessary in everyday tasks.
WHOQoL-BREF (for patients and caregivers)
Time frame: 20 min
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. The WHOQOL-BREF self-assessment was completed, together with socio-demographic and health status questions. Analyses of internal consistency, item-total correlations, discriminant validity and construct validity through confirmatory factor analysis, indicate that the WHOQOL-BREF has well to excellent psychometric properties of reliability and performs well in preliminary tests of validity. These results indicate that overall, the WHOQOL-BREF is a sound, cross-culturally valid assessment of QOL (Skevington et al, 2004).
EQ-5D
Time frame: 5 min
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics, and in face-to-face interviews. It is cognitively undemanding, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire (Oemar et al., 2013)
Pictorial Representation of Illness and Self Measure (PRISM) (patients and caregivers)
Time frame: 10min
The PRISM is a tool used to represent the burden of an illness graphically.in relation to oneself and one's life measured with the Self-Illness-Separation (SIS) instrument (Streffer et al., 2009; Kassardjian et al., 2008)
Burden Scale of family caregivers BSFC (Häusliche Pflegeskala) only caregivers
Time frame: 10min
The Burden Scale of Family Caregivers (BSFC) is a 28-item questionnaire developed ot measure the levels of perceived burden of family caregivers. The BSFC is designed for use * to identify individual caregiver service needs, plan intervention, and evaluate progress in clinical practice. * to evaluate service effectiveness of a program and to predict caregiver health and caregiving situation in research studies.
1 secondary outcome
Semi-structured Interview (patients and caregivers)
Time frame: 60min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Silke Neumann, MSC principal investigator
Zurich University of Applied Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness, MBSR in people with Stroke and Relatives, run by Zurich University of Applied Sciences.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silke Neumann, MSc (0041 58 934 49 76, neus@zhaw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: 20min). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2017.