Sensorimotor Changes in Stroke Following Mindfulness
Pilot Study of Sensorimotor Changes in Stroke Following Mindfulness
1 other identifier
interventional
11
1 country
1
Brief Summary
Roughly 30% of stroke survivors experience spasticity, a velocity-dependent increase in stretch reflexes. In this pilot study, the investigators aimed to examine the effects of mindfulness meditation on spasticity and quality of life in individuals after stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jul 2016
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2017
CompletedFirst Submitted
Initial submission to the registry
April 17, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedFebruary 22, 2024
February 1, 2024
7 months
April 17, 2018
February 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline Modified Ashworth Scale at 2 weeks
This scale measures post-stroke spasticity on a scale that ranges from 0-4 where 0 is no spasticity and the higher value represents a greater spasticity
This was measured before and after two weeks of meditation
Secondary Outcomes (4)
Change from Baseline Fugl Meyer Upper Extremity Scale at 2 weeks
This was measured before and after two weeks of meditation
Change from Baseline Stroke Specific Quality of Life Survey at 2 weeks
This was measured before and after two weeks of meditation
Change from Baseline Freiburg Mindfulness Inventory at 2 weeks
This was measured before and after two weeks of meditation
Change from Baseline Hospital Anxiety and Depression Scale at 2 weeks
This was measured before and after two weeks of meditation
Study Arms (1)
Mindfulness meditation
EXPERIMENTALTwo weeks of short, daily guided mindfulness meditations were provided.
Interventions
Short guided mindfulness meditations were provided on an MP3 player.
Eligibility Criteria
You may qualify if:
- Chronic stroke (greater than 1 year post stroke)
- Over 18 years old
- Moderate to severe motor deficits with self-reported spasticity
- No prior mindfulness meditation experience
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California
Los Angeles, California, 90089, United States
Related Publications (1)
Wathugala M, Saldana D, Juliano JM, Chan J, Liew SL. Mindfulness Meditation Effects on Poststroke Spasticity: A Feasibility Study. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19855941. doi: 10.1177/2515690X19855941.
PMID: 31215234DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- Assistant Professor
Study Record Dates
First Submitted
April 17, 2018
First Posted
May 23, 2018
Study Start
July 13, 2016
Primary Completion
February 17, 2017
Study Completion
February 17, 2017
Last Updated
February 22, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share