An interventional study of Mindfulness, MBSR in Stroke, Relatives and Motor Disorder, sponsored by Zurich University of Applied Sciences. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by Zurich University of Applied Sciences · Not applicable, Interventional, and Treatment
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.
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:
A-Phase The stroke patient continues his/her regular occupational treatment for eight weeks.
The caregivers get no study-related treatment.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 8 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Zurich University of Applied Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants (caregivers) fulfilling all of the following inclusion criteria are eligible for the study:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Mindfulness, MBSR
Participants (stroke patients and one of their closest relatives) will conduct an MBSR Course in Phase B
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).
Time frame: 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 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)
Time frame: 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/ )
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 10min
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.
Time frame: 60min
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2017; primary completion for Dec 2018, 12 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 12 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Zurich University of Applied Sciences