Los Angeles, California 90089

  • Spasticity, Muscle

Purpose:

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.


Study summary:

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.


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:


Study is Available At:


Original ID:

HS1500196C0005


NCT ID:

NCT03534856


Secondary ID:


Study Acronym:


Brief Title:

Sensorimotor Changes in Stroke Following Mindfulness


Official Title:

Pilot Study of Sensorimotor Changes in Stroke Following Mindfulness


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Southern California


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Study Dates

Start Date:July 13, 2016
Completion Date:February 17, 2017
Completion Type:Actual
Primary Completion Date:February 17, 2017
Primary Completion Type:Actual
Verification Date:May 2018
Last Changed Date:May 11, 2018
First Received Date:April 17, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change from Baseline Modified Ashworth Scale at 2 weeks
Time Frame:This was measured before and after two weeks of meditation
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Change from Baseline Fugl Meyer Upper Extremity Scale at 2 weeks
Time Frame:This was measured before and after two weeks of meditation
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Change from Baseline Stroke Specific Quality of Life Survey at 2 weeks
Time Frame:This was measured before and after two weeks of meditation
Safety Issues:False
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 Funct
Outcome Type:Secondary Outcome
Measure:Change from Baseline Freiburg Mindfulness Inventory at 2 weeks
Time Frame:This was measured before and after two weeks of meditation
Safety Issues:False
Description:This measure is of self-reported mindfulness capacity. Scores range from 14-56, where higher scores represent greater mindfulness ability.
Outcome Type:Secondary Outcome
Measure:Change from Baseline Hospital Anxiety and Depression Scale at 2 weeks
Time Frame:This was measured before and after two weeks of meditation
Safety Issues:False
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

Study Interventions

Intervention Type:Behavioral
Name:Mindfulness meditation
Description:Short guided mindfulness meditations were provided on an MP3 player.
Arm Name:Mindfulness meditation

Study Arms

Study Arm Type:Experimental
Arm Name:Mindfulness meditation
Description:Two weeks of short, daily guided mindfulness meditations were provided.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Southern California

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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