StrokeNCT03534856
Sensorimotor Changes in Stroke Following Mindfulness
A study testing Mindfulness meditation in people with Stroke and Spasticity, Muscle, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Spasticity, Muscle
- What is being tested?
- Mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2016to 17 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: Pilot Study of Sensorimotor Changes in Stroke Following Mindfulness
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.
Read the 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.
- Conditions
- Stroke, Spasticity, Muscle
- Being tested
- Mindfulness meditation
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
Short guided mindfulness meditations were provided on an MP3 player.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation | Experimental | Two weeks of short, daily guided mindfulness meditations were provided. Receives: Behavioral: Mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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.
Measured: This was measured before and after two weeks of meditation
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:
- 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
Measured: This was measured before and after two weeks of meditation
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.
Measured: This was measured before and after two weeks of meditation
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
Measured: This was measured before and after two weeks of meditation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start13 Jul 2016
- Primary completion17 Feb 2017
- Study completion17 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sook-Lei Liew, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534856
- Sponsor's protocol ID
- HS1500196C0005
- Status last verified
- Feb 2024
- First submitted
- 17 Apr 2018
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31215234
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Sensorimotor Changes in Stroke Following Mindfulness
- ClinicalTrials.gov ID
- NCT03534856
- Acronym / sponsor ID
- HS1500196C0005
- Conditions
- Stroke, Spasticity, Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 13 Jul 2016 (actual)
- Primary completion
- 17 Feb 2017 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation | Experimental | Behavioral: Mindfulness meditationTwo weeks of short, daily guided mindfulness meditations were provided. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditationShort guided mindfulness meditations were provided on an MP3 player. | Behavioural | Mindfulness meditation |
Primary outcome
Change from Baseline Modified Ashworth Scale at 2 weeks
Time frame: This was measured before and after two weeks of meditation
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
4 secondary outcomes
Change from Baseline Fugl Meyer Upper Extremity Scale at 2 weeks
Time frame: This was measured before and after two weeks of meditation
Change from Baseline Stroke Specific Quality of Life Survey at 2 weeks
Time frame: This was measured before and after two weeks of meditation
Change from Baseline Freiburg Mindfulness Inventory at 2 weeks
Time frame: This was measured before and after two weeks of meditation
Change from Baseline Hospital Anxiety and Depression Scale at 2 weeks
Time frame: This was measured before and after two weeks of meditation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 31215234Wathugala 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation in people with Stroke and Spasticity, Muscle, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Modified Ashworth Scale at 2 weeks (time frame: This was measured before and after two weeks of meditation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.