Brain ConcussionNCT03217695
A Study on the Effect of Mindfulness-based Yoga on Youth With Persistent Concussion Symptoms
A study testing Mindfulness-based Yoga Arm in people with Brain Concussion and Mild Traumatic Brain Injury, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial summary
Mild traumatic brain injury (mTBI), also known as concussion, is of great concern in the youth population, with incidences of injury steadily increasing within the past few years. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Brain Concussion, Mild Traumatic Brain Injury
- What is being tested?
- Mindfulness-based Yoga Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2016to 7 Oct 2016
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth between 13-18 years old;
- Persistent concussion symptoms greater than 1 month.
Who cannot join
- Less than 13 years old or greater than 18 years old;
- Non-English speaking;
- Severe (unmanaged) psychiatric diagnosis;
- Neurological disease;
- Diagnosed cardiac issues.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hopsital
Toronto, Ontario, M4G 1R8
About this study
Official title: A Pilot Study on the Effect of Mindfulness-based Yoga on Youth With Persistent Concussion Symptoms: Bridging Neurophysiological and Functional Outcomes
Mild traumatic brain injury (mTBI), also known as concussion, is of great concern in the youth population, with incidences of injury steadily increasing within the past few years. Current Canadian estimates have indicated that the total rate of concussions per 100,000 increased from 467 to 754 for boys and from 209 to 441 for girls from 2003-2010. As defined by the recent Zurich Consensus statement, concussion is a pathophysiological injury induced by biomechanical forces, which can be caused by impact to the head, neck or body. In 10-20% of youth, concussion symptoms persist in the weeks, months or even years following the injury. Consequently, youth with persistent concussion symptoms are unable to fully participate in the meaningful activities (e.g. attending school, engaging with friends and community) they did prior to the injury and experience a reduced quality of life.
Persistent concussion symptoms in youth requires an approach that directly addresses the rumination and attention to distressful thoughts about their functional performance, while still promoting appropriate levels of physical and cognitive demands. Targeting these constructs may shift the focus away from symptoms, while building self-efficacy and enhancing participation in daily activities. Mindfulness-based yoga (MBY) is a mind-body intervention that uses physical yoga poses, purposeful breathing techniques and a focus on being in the present moment. MBY encourages participants to develop moment-to-moment awareness of physical sensations, emotions, and thoughts, and promotes the cultivation of non-judgemental and accepting relationships to personal experiences. In chronic pain, fibromyalgia, mental health and now TBI populations, MBY has demonstrated benefits in physical (i.e. increased muscle strength, endurance), psychological (i.e. decreased stress, increased self-efficacy), cognitive (i.e. increased concentration) and social (i.e. emotional regulation, improved mood) domains. Although mindfulness based yoga has been validated as a form of rehabilitation in the adult population, its applicability for youth with persistent concussion symptoms has yet to be explored. Understanding the impact of a MBY intervention on this population may enhance management of persistent symptoms and ultimately, participation in meaningful activities.
Read more
In addition to the functional sequelae that ensue following this injury, concussion in both the acute and persistent phases is being recognized as a neurophysiological injury. Traditional methods of assessment following concussion place emphasis on subjective self-report and administration of neuropsychological batteries. These assessments are used in an effort to return the youth to activity (i.e school, sport). However, these methods can be unreliable as youth have a high incentive to return to play and neurocognitive resolution does not necessarily equate to pre-injury function. To augment these measures, an objective indicator of neurophysiological stress is needed. Heart rate variability (HRV) is an objective, neurophysiological indicator of autonomic nervous system functioning. HRV is quantified by measuring the time intervals between heartbeats. Increased variability in heart rate (i.e. increased HRV) is seen as healthy neurophysiological function, demonstrating an individual's ability to adapt and be flexible to the demands of the environment. Conversely, decreased HRV is demonstrative of an individual's reduced ability to respond flexibly to their environment. Investigating the impact of persistent concussion symptoms on HRV has the potential to enhance our understanding of autonomic nervous system functioning in the chronic phases of this injury for an understudied population.
The specific objectives are to: (1) adapt the MBY intervention protocol to suit the unique needs of youth with mTBI (i.e. safety, fatigue), (2) collect data on the impact of MBY on HRV, self-efficacy and participation, (3) describe changes in HRV, self-efficacy and participation associated with MBY across pre-intervention, post-intervention and 3 months following intervention, (4) identify if post concussion symptoms change (i.e. increase or decrease) following MBY and (5) identify if changes in post concussion symptoms occur with changes in HRV, self-efficacy and participation.
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury
- Being tested
- Mindfulness-based Yoga Arm
- Keywords
- Heart rate variability, Self-efficacy, Pediatrics, Mindfulness-based yoga, Symptoms
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Yoga ArmBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Yoga Arm | Experimental | 8-week period, 1x/week for 45-60 minutes/session. Sessions 1-2: Participants instructed to focus their attention on their breath, and the physical sensations in their bodies while holding the yoga postures, to develop sustained and focused attention. Sessions 3-4: exploring the sensorial qualities of physical sensation in the body whether pleasant or unpleasant and to notice thoughts and label them (e.g., "planning", "remembering"), and to the same with emotions (e.g., "worry", "frustration", "fear") to practice disengaging from automatic associative thinking. Session 6-8: Instructor will guide participants to allow sensations of discomfort or effort to be as they are and to bring awareness to automatic patterns of reactivity. The goal is to foster distress tolerance, provide opportunities for participants to practice self-care, and allow an opportunity to observe and respond skillfully, instead of react automatically, to unpleasant stimuli (sensations, emotions). Receives: Behavioral: Mindfulness-based Yoga Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Children's Assessment of Participation and Employment (CAPE) from pre-intervention to 3 month follow-up
Participants are asked to complete the 55-item questionnaire and answer questions about an activity based on five dimensions of participation: diversity (number of activities done), intensity, (with whom the youth does an activity with), where (they do it) and enjoyment of activities (King et al., 2007).
Measured: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Change in Self-Efficacy Questionnaire for Children (SEQ-C) from pre-intervention to 3 month follow-up
Participants are asked to rate their perceived ability to accomplish a task between 1 (not at all) to 5 (very well). The questions cover three domains of self-efficacy, namely social, academic and emotional.
Measured: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Change in Heart rate variability from pre-intervention to 3 month follow-up
Time (seconds) of beat-to-beat intervals, measured over a 24 hour recording
Measured: Pre-intervention, during each of the 8 weeks of mindfulness-based yoga (for 24 hours starting at 6PM when each of the yoga sessions begins until 6PM the following day), post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Secondary outcomes (2)
Post-Concussion Symptom Inventory (PCSI)
It is a 21-item self-report measure where symptom severity is rated on a scale of 0 to 6 (0= not at all, 3= moderate, 6=severe) for symptoms that occur within physical, cognitive, fatigue and emotional domains
Measured: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Godin Leisure-Time Exercise Questionnaire (GLTE)
It is a self-report measure that assesses weekly physical activity engagement by asking participants to indicate how many times per week they engage in strenuous (heart beats rapidly), moderate (not exhausting) or mild exercise (minimal effort).
Measured: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start4 Apr 2016
- Primary completion7 Oct 2016
- Study completion7 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Nick Reed, MScOT, PhD, Principal investigator, Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217695
- Sponsor's protocol ID
- BloorviewKR_MBY
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Publications
Abaji JP, Curnier D, Moore RD, Ellemberg D. Persisting Effects of Concussion on Heart Rate Variability during Physical Exertion. J Neurotrauma. 2016 May 1;33(9):811-7. doi: 10.1089/neu.2015.3989. Epub 2015 Oct 8.
PubMed 26159461Azulay J, Smart CM, Mott T, Cicerone KD. A pilot study examining the effect of mindfulness-based stress reduction on symptoms of chronic mild traumatic brain injury/postconcussive syndrome. J Head Trauma Rehabil. 2013 Jul-Aug;28(4):323-31. doi: 10.1097/HTR.0b013e318250ebda.
PubMed 22688212Belanger HG, Kretzmer T, Vanderploeg RD, French LM. Symptom complaints following combat-related traumatic brain injury: relationship to traumatic brain injury severity and posttraumatic stress disorder. J Int Neuropsychol Soc. 2010 Jan;16(1):194-9. doi: 10.1017/S1355617709990841. Epub 2009 Sep 17.
PubMed 19758488Blechert J, Michael T, Grossman P, Lajtman M, Wilhelm FH. Autonomic and respiratory characteristics of posttraumatic stress disorder and panic disorder. Psychosom Med. 2007 Dec;69(9):935-43. doi: 10.1097/PSY.0b013e31815a8f6b. Epub 2007 Nov 8.
PubMed 17991823Conder RL, Conder AA. Heart rate variability interventions for concussion and rehabilitation. Front Psychol. 2014 Aug 13;5:890. doi: 10.3389/fpsyg.2014.00890. eCollection 2014.
PubMed 25165461Deshpande S, Nagendra HR, Nagarathna R. A randomized control trial of the effect of yoga on Gunas (personality) and Self esteem in normal healthy volunteers. Int J Yoga. 2009 Jan;2(1):13-21. doi: 10.4103/0973-6131.43287.
PubMed 21234210Galantino ML, Galbavy R, Quinn L. Therapeutic effects of yoga for children: a systematic review of the literature. Pediatr Phys Ther. 2008 Spring;20(1):66-80. doi: 10.1097/PEP.0b013e31815f1208.
PubMed 18300936Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
PubMed 20350028Jonsson C, Andersson EE. Mild traumatic brain injury: a description of how children and youths between 16 and 18 years of age perform leisure activities after 1 year. Dev Neurorehabil. 2013;16(1):1-8. doi: 10.3109/17518423.2012.704955. Epub 2012 Oct 3.
PubMed 23030702King GA, Law M, King S, Hurley P, Hanna S, Kertoy M, Rosenbaum P. Measuring children's participation in recreation and leisure activities: construct validation of the CAPE and PAC. Child Care Health Dev. 2007 Jan;33(1):28-39. doi: 10.1111/j.1365-2214.2006.00613.x.
PubMed 17181750Leddy JJ, Kozlowski K, Fung M, Pendergast DR, Willer B. Regulatory and autoregulatory physiological dysfunction as a primary characteristic of post concussion syndrome: implications for treatment. NeuroRehabilitation. 2007;22(3):199-205.
PubMed 17917170Macpherson A, Fridman L, Scolnik M, Corallo A, Guttmann A. A population-based study of paediatric emergency department and office visits for concussions from 2003 to 2010. Paediatr Child Health. 2014 Dec;19(10):543-6. doi: 10.1093/pch/19.10.543.
PubMed 25587234McCrory P, Meeuwisse W, Aubry M, Cantu B, Dvorak J, Echemendia R, Engebretsen L, Johnston K, Kutcher J, Raftery M, Sills A, Benson B, Davis G, Ellenbogen R, Guskiewicz K, Herring SA, Iverson G, Jordan B, Kissick J, McCrea M, McIntosh A, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator C, Turner M. Consensus statement on Concussion in Sport - The 4th International Conference on Concussion in Sport held in Zurich, November 2012. Phys Ther Sport. 2013 May;14(2):e1-e13. doi: 10.1016/j.ptsp.2013.03.002. No abstract available.
PubMed 23664041Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.
PubMed 22029804Reed N, Murphy J, Dick T, Mah K, Paniccia M, Verweel L, Dobney D, Keightley M. A multi-modal approach to assessing recovery in youth athletes following concussion. J Vis Exp. 2014 Sep 25;(91):51892. doi: 10.3791/51892.
PubMed 25285728
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Effect of Mindfulness-based Yoga on Youth With Persistent Concussion Symptoms: Bridging Neurophysiological and Functional Outcomes
- ClinicalTrials.gov ID
- NCT03217695
- Acronym / sponsor ID
- BloorviewKR_MBY
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury
- Keywords
- Heart rate variability, Self-efficacy, Pediatrics, Mindfulness-based yoga, Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 7 Oct 2016 (actual)
- Study completion
- 7 Oct 2016 (actual)
- First posted
- 14 Jul 2017 (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.
Mild traumatic brain injury (mTBI), also known as concussion, is of great concern in the youth population, with incidences of injury steadily increasing within the past few years. Current Canadian estimates have indicated that the total rate of concussions per 100,000 increased from 467 to 754 for boys and from 209 to 441 for girls from 2003-2010. As defined by the recent Zurich Consensus statement, concussion is a pathophysiological injury induced by biomechanical forces, which can be caused by impact to the head, neck or body. In 10-20% of youth, concussion symptoms persist in the weeks, months or even years following the injury. Consequently, youth with persistent concussion symptoms are unable to fully participate in the meaningful activities (e.g. attending school, engaging with friends and community) they did prior to the injury and experience a reduced quality of life.
Persistent concussion symptoms in youth requires an approach that directly addresses the rumination and attention to distressful thoughts about their functional performance, while still promoting appropriate levels of physical and cognitive demands. Targeting these constructs may shift the focus away from symptoms, while building self-efficacy and enhancing participation in daily activities. Mindfulness-based yoga (MBY) is a mind-body intervention that uses physical yoga poses, purposeful breathing techniques and a focus on being in the present moment. MBY encourages participants to develop moment-to-moment awareness of physical sensations, emotions, and thoughts, and promotes the cultivation of non-judgemental and accepting relationships to personal experiences. In chronic pain, fibromyalgia, mental health and now TBI populations, MBY has demonstrated benefits in physical (i.e. increased muscle strength, endurance), psychological (i.e. decreased stress, increased self-efficacy), cognitive (i.e. increased concentration) and social (i.e. emotional regulation, improved mood) domains. Although mindfulness based yoga has been validated as a form of rehabilitation in the adult population, its applicability for youth with persistent concussion symptoms has yet to be explored. Understanding the impact of a MBY intervention on this population may enhance management of persistent symptoms and ultimately, participation in meaningful activities.
In addition to the functional sequelae that ensue following this injury, concussion in both the acute and persistent phases is being recognized as a neurophysiological injury. Traditional methods of assessment following concussion place emphasis on subjective self-report and administration of neuropsychological batteries. These assessments are used in an effort to return the youth to activity (i.e school, sport). However, these methods can be unreliable as youth have a high incentive to return to play and neurocognitive resolution does not necessarily equate to pre-injury function. To augment these measures, an objective indicator of neurophysiological stress is needed. Heart rate variability (HRV) is an objective, neurophysiological indicator of autonomic nervous system functioning. HRV is quantified by measuring the time intervals between heartbeats. Increased variability in heart rate (i.e. increased HRV) is seen as healthy neurophysiological function, demonstrating an individual's ability to adapt and be flexible to the demands of the environment. Conversely, decreased HRV is demonstrative of an individual's reduced ability to respond flexibly to their environment. Investigating the impact of persistent concussion symptoms on HRV has the potential to enhance our understanding of autonomic nervous system functioning in the chronic phases of this injury for an understudied population.
The specific objectives are to: (1) adapt the MBY intervention protocol to suit the unique needs of youth with mTBI (i.e. safety, fatigue), (2) collect data on the impact of MBY on HRV, self-efficacy and participation, (3) describe changes in HRV, self-efficacy and participation associated with MBY across pre-intervention, post-intervention and 3 months following intervention, (4) identify if post concussion symptoms change (i.e. increase or decrease) following MBY and (5) identify if changes in post concussion symptoms occur with changes in HRV, self-efficacy and participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Yoga Arm | Experimental | Behavioral: Mindfulness-based Yoga Arm8-week period, 1x/week for 45-60 minutes/session. Sessions 1-2: Participants instructed to focus their attention on their breath, and the physical sensations in their bodies while holding the yoga postures, to develop sustained and focused attention. Sessions 3-4: exploring the sensorial qualities of physical sensation in the body whether pleasant or unpleasant and to notice thoughts and label them (e.g., "planning", "remembering"), and to the same with emotions (e.g., "worry", "frustration", "fear") to practice disengaging from automatic associative thinking. Session 6-8: Instructor will guide participants to allow sensations of discomfort or effort to be as they are and to bring awareness to automatic patterns of reactivity. The goal is to foster distress tolerance, provide opportunities for participants to practice self-care, and allow an opportunity to observe and respond skillfully, instead of react automatically, to unpleasant stimuli (sensations, emotions). |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Youth between 13-18 years old;
- Persistent concussion symptoms greater than 1 month.
Key exclusion criteria (5 listed)
- Less than 13 years old or greater than 18 years old;
- Non-English speaking;
- Severe (unmanaged) psychiatric diagnosis;
- Neurological disease;
- Diagnosed cardiac issues.
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-based Yoga Arm | Behavioural | Mindfulness-based Yoga Arm |
Primary outcome
Change in Children's Assessment of Participation and Employment (CAPE) from pre-intervention to 3 month follow-up
Time frame: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Participants are asked to complete the 55-item questionnaire and answer questions about an activity based on five dimensions of participation: diversity (number of activities done), intensity, (with whom the youth does an activity with), where (they do it) and enjoyment of activities (King et al., 2007).
Change in Self-Efficacy Questionnaire for Children (SEQ-C) from pre-intervention to 3 month follow-up
Time frame: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Participants are asked to rate their perceived ability to accomplish a task between 1 (not at all) to 5 (very well). The questions cover three domains of self-efficacy, namely social, academic and emotional.
Change in Heart rate variability from pre-intervention to 3 month follow-up
Time frame: Pre-intervention, during each of the 8 weeks of mindfulness-based yoga (for 24 hours starting at 6PM when each of the yoga sessions begins until 6PM the following day), post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Time (seconds) of beat-to-beat intervals, measured over a 24 hour recording
2 secondary outcomes
Post-Concussion Symptom Inventory (PCSI)
Time frame: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Godin Leisure-Time Exercise Questionnaire (GLTE)
Time frame: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
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 14 Jul 2017.
- Background: PubMed 26159461Abaji JP, Curnier D, Moore RD, Ellemberg D. Persisting Effects of Concussion on Heart Rate Variability during Physical Exertion. J Neurotrauma. 2016 May 1;33(9):811-7. doi: 10.1089/neu.2015.3989. Epub 2015 Oct 8.
- Background: PubMed 22688212Azulay J, Smart CM, Mott T, Cicerone KD. A pilot study examining the effect of mindfulness-based stress reduction on symptoms of chronic mild traumatic brain injury/postconcussive syndrome. J Head Trauma Rehabil. 2013 Jul-Aug;28(4):323-31. doi: 10.1097/HTR.0b013e318250ebda.
- Background: PubMed 19758488Belanger HG, Kretzmer T, Vanderploeg RD, French LM. Symptom complaints following combat-related traumatic brain injury: relationship to traumatic brain injury severity and posttraumatic stress disorder. J Int Neuropsychol Soc. 2010 Jan;16(1):194-9. doi: 10.1017/S1355617709990841. Epub 2009 Sep 17.
- Background: PubMed 17991823Blechert J, Michael T, Grossman P, Lajtman M, Wilhelm FH. Autonomic and respiratory characteristics of posttraumatic stress disorder and panic disorder. Psychosom Med. 2007 Dec;69(9):935-43. doi: 10.1097/PSY.0b013e31815a8f6b. Epub 2007 Nov 8.
- Background: PubMed 25165461Conder RL, Conder AA. Heart rate variability interventions for concussion and rehabilitation. Front Psychol. 2014 Aug 13;5:890. doi: 10.3389/fpsyg.2014.00890. eCollection 2014.
- Background: PubMed 21234210Deshpande S, Nagendra HR, Nagarathna R. A randomized control trial of the effect of yoga on Gunas (personality) and Self esteem in normal healthy volunteers. Int J Yoga. 2009 Jan;2(1):13-21. doi: 10.4103/0973-6131.43287.
- Background: PubMed 18300936Galantino ML, Galbavy R, Quinn L. Therapeutic effects of yoga for children: a systematic review of the literature. Pediatr Phys Ther. 2008 Spring;20(1):66-80. doi: 10.1097/PEP.0b013e31815f1208.
- Background: PubMed 20350028Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
- Background: PubMed 23030702Jonsson C, Andersson EE. Mild traumatic brain injury: a description of how children and youths between 16 and 18 years of age perform leisure activities after 1 year. Dev Neurorehabil. 2013;16(1):1-8. doi: 10.3109/17518423.2012.704955. Epub 2012 Oct 3.
- Background: PubMed 17181750King GA, Law M, King S, Hurley P, Hanna S, Kertoy M, Rosenbaum P. Measuring children's participation in recreation and leisure activities: construct validation of the CAPE and PAC. Child Care Health Dev. 2007 Jan;33(1):28-39. doi: 10.1111/j.1365-2214.2006.00613.x.
- Background: PubMed 17917170Leddy JJ, Kozlowski K, Fung M, Pendergast DR, Willer B. Regulatory and autoregulatory physiological dysfunction as a primary characteristic of post concussion syndrome: implications for treatment. NeuroRehabilitation. 2007;22(3):199-205.
- Background: PubMed 25587234Macpherson A, Fridman L, Scolnik M, Corallo A, Guttmann A. A population-based study of paediatric emergency department and office visits for concussions from 2003 to 2010. Paediatr Child Health. 2014 Dec;19(10):543-6. doi: 10.1093/pch/19.10.543.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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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.
Nick Reed, MScOT, PhD principal investigator
Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital
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-based Yoga Arm in people with Brain Concussion and Mild Traumatic Brain Injury, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
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 2 inclusion and 5 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 14 Jul 2017. 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 Canada. 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 in Children's Assessment of Participation and Employment (CAPE) from pre-intervention to 3 month follow-up (time frame: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up). The study lists 3 primary outcomes in all. 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 NCT03217695, which also lists 17 linked publications.
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 14 Jul 2017; AzTrials last refreshed its copy on 1 Nov 2026.