Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training

NCT03271788 | Unknown

• 1 other identifier: 97106125033101
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Relatives; Motor Disorder; Attention Deficit; Quality of Life

Outcome Measures

Primary Outcomes (8)

• 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).

  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 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/ )

  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.

  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).

  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)

  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)

  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.

  10min

Secondary Outcomes (1)

• Semi-structured Interview (patients and caregivers)

  60min

Study Arms (1)

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.

Other: Mindfulness, MBSR

Interventions

Mindfulness, MBSR OTHER

Participants (stroke patients and one of their closest relatives) will conduct an MBSR Course in Phase B

stroke patients and caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Close relative who is primary in charge and bear the largest burden of the caregiving of the stroke patient

You may not qualify if:

• 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

Sponsors & Collaborators

• Zurich University of Applied Sciences: lead

MeSH Terms

Conditions

Stroke; Motor Disorders; Attention Deficit Disorder with Hyperactivity

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Silke Neumann, MSC

  Zurich University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silke Neumann, MSc

CONTACT

0041 58 934 49 76; neus@zhaw.ch

Heidrun Becker, Prof

CONTACT

0041 58 934 64 77; heidrun.becker@zhaw.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 5, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 5, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share