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Sensorimotor Changes in Stroke Following Mindfulness

Primary Purpose

Stroke, Spasticity, Muscle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness meditation
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness meditation

Arm Description

Two weeks of short, daily guided mindfulness meditations were provided.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline Fugl Meyer Upper Extremity Scale at 2 weeks
This is a measure of sensory and motor impairment after stroke. This scale ranges from 0 - 66, where 0 represents greater impairment and 66 represents no impairment.
Change from Baseline Stroke Specific Quality of Life Survey at 2 weeks
This is a quality of life survey for individuals after stroke, with the following subscales: i. Mobility (Range: 0-30), higher values represent a better outcome ii. Energy (Range: 0-15), higher values represent a better outcome iii. Upper Extremity Function (Range: 0-25), higher values represent a better outcome iv. Work/productivity (Range: 0-15), higher values represent a better outcome v. Mood (Range: 0-25), higher values represent a better outcome vi. Self-care (Range: 0-25), higher values represent a better outcome vii. Social Roles (Range: 0-25), higher values represent a better outcome viii. Family Roles (Range: 0-15), higher values represent a better outcome ix. Vision (Range: 0-15), higher values represent a better outcome x. Language (Range: 0-25), higher values represent a better outcome xi. Thinking (Range: 0-15), higher values represent a better outcome xii. Personality (Range: 0-15), higher values represent a better outcome
Change from Baseline Freiburg Mindfulness Inventory at 2 weeks
This measure is of self-reported mindfulness capacity. Scores range from 14-56, where higher scores represent greater mindfulness ability.
Change from Baseline Hospital Anxiety and Depression Scale at 2 weeks
This is an assessment of anxiety and depression. There are two subscales - i. Anxiety Subscale (Range: 0-21), higher values represent a worse outcome ii. Depression Subscale (Range: 0-21), higher values represent a worse outcome

Full Information

First Posted
April 17, 2018
Last Updated
May 11, 2018
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT03534856
Brief Title
Sensorimotor Changes in Stroke Following Mindfulness
Official Title
Pilot Study of Sensorimotor Changes in Stroke Following Mindfulness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 13, 2016 (Actual)
Primary Completion Date
February 17, 2017 (Actual)
Study Completion Date
February 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Thirty percent of stroke survivors experience spasticity, a velocity dependent increase in stretch reflexes, which negatively affects quality of life and activities of daily living (Thibaut et al. 2013). Spasticity is a secondary neurological symptom induced by neurological hyperreflexia seen in stroke and other neurological disorders (Bose et al. 2015). If left untreated, stroke survivors may develop contractures which can further impede motor recovery and participation in activities of daily life (Thibaut et al. 2013). Spasticity is typically treated with medications, botox injections, baclofen intrathecal pumps, occupational therapy, and physical therapy, but current treatment options are often expensive and effectiveness is generally unsatisfactory (Kheder and Nair 2012). Thus, there is a need to find low-cost, effective, and accessible methods that have the potential to help reduce spasticity and promote recovery. Increased spasticity has been linked to emotion-based stress, such as anxiety (Bhimani and Anderson 2014). Previous research has anecdotally linked meditation, a technique that has been used to reduce anxiety, to decreased post-stroke spasticity (Bhimani and Anderson 2014). In this pilot study, the researchers aimed to test whether two weeks of mindfulness meditation could lead to reduced anxiety and reduced post-stroke spasticity. Briefly, mindfulness meditation is a type of meditation that trains awareness and acceptance of the current inner and outer reality, and is often taught through Jon Kabat-Zinn's 8-week Mindfulness Based Stress Reduction (MBSR) course (Kabat-Zinn 1996). Importantly, while it is typically taught by an experienced teacher over a series of sessions, studies have also shown successful mindfulness practice via audio/video recording (Potter 2017), allowing for greater accessibility to mindfulness training for broader audiences, including those with mobility limitations. Although studies have found that mindfulness meditation may be linked to mood, anxiety, and pain reduction, it has not been directly connected to motor function or spasticity (Creswell et al. 2014; Moustgaard et al. 2007; Zeidan et al. 2010). Specifically, mindfulness intervention studies have reported decreased mental fatigue in people with TBI or stroke (Johansson et al. 2012) and a reduction in psychological stress and improvement in cognitive function in patients with multiple sclerosis (Blankespoor et al. 2017). One systematic review showed that mindfulness meditation helped patients cope with their chronic illnesses, including cancer, depression and general anxiety disorder, by improving their mood and anxiety symptoms (Hofmann et al. 2010). In stroke and transient ischemic attack survivors, there is small but growing evidence that mindfulness promotes positive results for psychological and psychosocial health (Lawrence et al. 2013). A pilot study with individuals after stroke used an 8-week Mindfulness-Based Cognitive Therapy (MBCT) intervention, which is a combination of MBSR with some insights from cognitive behavioral therapy, and found a reduction in anxiety and depression and an increase in quality of life, including physical functioning. (Moustgaard et al. 2007). Because of the anecdotal evidence linking stress to increased spasticity and the clinical evidence linking meditation to decreased stress, the researchers conducted a pilot study to explore whether two weeks of guided mindfulness meditation-a low-cost, home-based intervention-could improve spasticity, along with quality of life, stress and anxiety, in individuals after stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity, Muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness meditation
Arm Type
Experimental
Arm Description
Two weeks of short, daily guided mindfulness meditations were provided.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness meditation
Intervention Description
Short guided mindfulness meditations were provided on an MP3 player.
Primary Outcome Measure Information:
Title
Change from Baseline Modified Ashworth Scale at 2 weeks
Description
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
Time Frame
This was measured before and after two weeks of meditation
Secondary Outcome Measure Information:
Title
Change from Baseline Fugl Meyer Upper Extremity Scale at 2 weeks
Description
This is a measure of sensory and motor impairment after stroke. This scale ranges from 0 - 66, where 0 represents greater impairment and 66 represents no impairment.
Time Frame
This was measured before and after two weeks of meditation
Title
Change from Baseline Stroke Specific Quality of Life Survey at 2 weeks
Description
This is a quality of life survey for individuals after stroke, with the following subscales: i. Mobility (Range: 0-30), higher values represent a better outcome ii. Energy (Range: 0-15), higher values represent a better outcome iii. Upper Extremity Function (Range: 0-25), higher values represent a better outcome iv. Work/productivity (Range: 0-15), higher values represent a better outcome v. Mood (Range: 0-25), higher values represent a better outcome vi. Self-care (Range: 0-25), higher values represent a better outcome vii. Social Roles (Range: 0-25), higher values represent a better outcome viii. Family Roles (Range: 0-15), higher values represent a better outcome ix. Vision (Range: 0-15), higher values represent a better outcome x. Language (Range: 0-25), higher values represent a better outcome xi. Thinking (Range: 0-15), higher values represent a better outcome xii. Personality (Range: 0-15), higher values represent a better outcome
Time Frame
This was measured before and after two weeks of meditation
Title
Change from Baseline Freiburg Mindfulness Inventory at 2 weeks
Description
This measure is of self-reported mindfulness capacity. Scores range from 14-56, where higher scores represent greater mindfulness ability.
Time Frame
This was measured before and after two weeks of meditation
Title
Change from Baseline Hospital Anxiety and Depression Scale at 2 weeks
Description
This is an assessment of anxiety and depression. There are two subscales - i. Anxiety Subscale (Range: 0-21), higher values represent a worse outcome ii. Depression Subscale (Range: 0-21), higher values represent a worse outcome
Time Frame
This was measured before and after two weeks of meditation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: -
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31215234
Citation
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.
Results Reference
derived

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Sensorimotor Changes in Stroke Following Mindfulness

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