UnknownNot Applicable

Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training

8 participantsStarted 2017-12-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wolf Motor Function Test

Timeframe: 20min

Motor Activity LOG (MAL)

Timeframe: Time of performance: ca. 15 min

Assessment of Motor and Process Skills (AMPS)

Timeframe: 50min

ASPA (Attention and Performance Self-Assessment)

Timeframe: 5min

WHOQoL-BREF (for patients and caregivers)

Timeframe: 20 min

EQ-5D

Timeframe: 5 min

Pictorial Representation of Illness and Self Measure (PRISM) (patients and caregivers)

Timeframe: 10min

Burden Scale of family caregivers BSFC (Häusliche Pflegeskala) only caregivers

Trial details

NCT IDNCT03271788

SponsorZurich University of Applied Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-31

Contact for this trial

Silke Neumann, MSc

0041 58 934 49 76 neus@zhaw.ch

View on ClinicalTrials.gov More Stroke trials