Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training

Stroke Clinical Trial

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

Status Not yet recruiting

Clinical 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.

Clinical Trial 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).

1. 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)

2. A-Phase The stroke patient continues his/her regular occupational treatment for eight weeks.

The caregivers get no study-related treatment.

3. 2nd (Midterm)-Measurement Same procedure as the baseline measurement.

4. 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.

5. 3rd (Final) Measurement Same procedure as the baseline and second (Midterm-) measurement. ;

Related Conditions & MeSH terms

• Attention Deficit
• Attention Deficit Disorder with Hyperactivity
• Motor Disorder
• Motor Disorders
• Quality of Life
• Relatives
• Stroke

• NCT number: NCT03271788
• Study type: Interventional
• Source: Zurich University of Applied Sciences
• Contact: Silke Neumann, MSc
• Phone: 0041 58 934 49 76
• Email: neus@zhaw.ch
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2017
• Completion date: December 31, 2018